StandardThe In This Issue CEO Column Science and Standards Global Health Impact Programs Inside USP USP Hosts International Exchange on Public Quality Standards for Medicines and Foods with Regulatory Authorities and National Reference Labs R egulatory and enforcement agencies, as well as national reference laboratories around the world regularly seek advice from the U.S. Pharmacopeial Convention (USP) on how to establish, implement and enforce public quality standards to help ensure the quality of medicines, foods and dietary supplements available to their populations. On June 17, USP welcomed representatives from three different continents to its International Training Program (ITP). Delegations from the Middle East, Africa, Russia and the former Soviet Republics spent two weeks at USP headquarters learning about USP processes and standard-setting activities for chemical and biological medicines, as well for herbal medicines, dietary supplements, and foods. USP staff and ITP participants from countries in Africa and the Middle East. “Public standards are critically important to help ensure the quality of all medicines,” said Dr. Roger L. Williams, chief executive officer of USP. “The International Training Program is a unique opportunity for countries interested in improving their health systems and regulatory framework, and also for USP to learn more about the global regulatory and compendial landscape.” Speakers addressed enforcement and scientific aspects of implementing public standards, and how the global market is influencing the regulation of medicines and dietary supplements, as well as healthcare quality and safety, quality assurance and global health programs. “With manufacturing and commercialization increasingly crossing borders, it is important to consider the need to exchange information with other regulatory and scientific organizations around the globe,” said Dr. Fahad Ibrahim Al-Jenoobi,executive director for the Product Evaluation and Standards Setting division of the Saudi Food and Drug Authority, and one of the ITP participants “USP is facilitating the improvement of health systems by providing the opportunity to openly discuss the issues involved in supplying good quality medicines.” Delegations spent two weeks learning about USP processes and standard-setting activities for chemical and biological medicines, as well for herbal medicines, dietary supplements, and foods. Measurable Value to Regulatory Bodies Worldwide USP started ITP in 2012 to foster an exchange of information among medicines control authorities around the world. Part of this year’s program included a presentation of the current regulatory framework in each of the countries invited to ITP. While some of them are in the beginning stages of establishing a regulatory body and a national reference laboratory, others are further along in following USP’s model and are already working to enforce public standards of quality and offer good quality medicines to their populations. Continued on page 15. See International Training Program Vol. 11 | Issue 2 | Fall 2013 In This Issue CEO Column 3 Message from the CEO Shared Opportunities and Challenges for ChP and USP 4 Q & A with Roger Williams Upcoming Events Workshops USP Headquarters– Rockville, MD 4 Economically-Motivated Adulteration of Food Ingredients and Dietary Supplements Co-sponsored by: USP, IFT, NPA and UNPA September 26–27, 2013 4 Ophthalmic Preparations October 21–22, 2013 4 Cell- and Tissue-based Regenerative Medicine Products: From Characterization to Compendial Assays November 7–8, 2013 4 <1> Injections and Implanted Drug Products (Parenterals)—Product Quality Tests November 22, 2013 4 Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables Co-sponsored by: USP and PQRI December 9–10, 2013 4 Nanomaterial Drug Products: Current Experience and Management of Potential Risks Co-sponsored by: USP and PQRI January 14–15, 2014 4 Dissolution Testing of Capsules March 24–15, 2014 4 Good Distribution Practices Workshop May 19–20, 2014 4 6th Bioassay Workshop June 2–3, 2014 Science and Standards 5 Economically-Motivated Adulteration of Food Ingredients and Dietary Supplements Workshop 5 USP Global Education and Training Expanding Offerings and Technology 6 First 2010-2015 USP Excipients Stakeholder Forum Held in June 7 USP Hosts PNP Stakeholder Forum 7 USP Revises General Chapter <771> Ophthalmic Ointments to Include All Dosage Forms 8 New Standards for Pomegranate Juice, Spirulina and Other Food Ingredients Proposed for FCC 9 USP Officials Visit Vietnam and Korea 10 Science & Standards Symposium in São Paulo 10 2013–2014 USP Global Fellowship Awards 11 First USP Workshop on Host Cell Impurities in Biotechnology Products Co-Hosted by BEBPA 11 Highlights of Upcoming USP Workshops Global Health Impact Programs 12 CePAT’s First Group of Students Successfully Complete Course Module on Medicines Dossier 13 Regional Training in Latin America Helps National Labs Control Medicines Quality 13 Senegal Regulators Recall Five Lots of ACTs Inside USP 14 USP Announces New Senior Vice President of Development 14 USP Announces New Acting Chief Operating Officer 14 On-Demand Webinars Provide Resolution Updates Visit www.usp.org/meetings-courses/calendar for more information on these events. Message from the CEO Shared Opportunities and Challenges for ChP and USP Roger L. Williams, M.D. R eaders of the “Message from the CEO” column may recall that I occasionally share—or give over—this space to another author. In this instance, I’m both honored and delighted to share the column with a colleague, friend, and compendial partner, Mr. Zhang Wei, Secretary General of the Chinese Pharmacopoeial Commission (ChP). There are many reasons to do this, but principal among them is that Zhang Wei and I are welcoming attendees to two important meetings the week of September 18 in Baltimore, Maryland. What are these meetings and why are they important? First is the Science & Standards Symposium that ChP and USP are sponsoring jointly in the United States for the first time. USP has held annual science meetings for many years, which have grown and changed in exciting ways. USP also has ‘echoed’ such meetings in other countries around the world, working collaboratively with our pharmacopoeial partners. In parallel—and as part of the Memorandum of Understanding between ChP and USP signed in 2008 (renewed in 2012)—ChP and USP began holding a science meeting in China every other year. What makes the 2013 Science & Standards Symposium significant is a new agreement that the two pharmacopoeias will now hold these every year, not just biennially, alternating them between the US and the China. Thus ChP and USP will plan a joint Science & Standards Symposium in China in 2014. USP will, of course, continue its Science & Standards Symposia in the US even in the ‘off’ years when ChP and USP are meeting in China. Conceptually, this plan draws together USP and ChP into even more important bonds of collaboration and synergy, building on prior successes. We also are hosting the third Global Summit of the Pharmacopoeias (GSP), an initiative of the ChP begun during the tenure of Mr. Zhang’s predecessor, Mr. Wu Zhen, and now continued by Mr. Zhang. The meeting in Baltimore takes place on Friday, September 20, 2013, following the close of the Science & Standards Symposium. This GSP features a new, open-to-the-public session on global pharmacopoeial harmonization activities and future direction. The GSP has special importance because it is a meeting of national pharmacopoeias that allows each member to exchange information and focus on its own interests and challenges. The World Health Organization (WHO) also has an effort with pharmacopoeias, which is resulting in a multilateral effort to create “Good Pharmacopoeial Practices” (GPhPs). WHO will take the completed GPhPs to the Expert Committee on Specifications for Pharmaceutical Preparations, which draws on global pharmacopoeial expertise to advance its own International Pharmacopoeia. WHO has been invited and is most welcome to attend both the Science & Standards Symposium and the GSP. As my colleague Mr. Zhang notes, “Both the Chinese and the US pharmacopoeias want to underscore that the reason for all these meetings of diverse national and international health organizations is to help ensure, in an increasingly globalized world, the quality of medicines and foods. And we emphasize the importance of good science as the essential foundation of pharmacopoeial standards and practices. But most important of all is the friendship that arises from meeting, talking, and listening to opportunities and challenges that confront us all in bringing good quality food and medicines to practitioners, patients, and consumers everywhere.” g Most important of all is the friendship that arises from meeting, talking, and listening to opportunities and challenges that confront us all in bringing good quality food and medicines to practitioners, patients, and consumers everywhere. Zhang Wei, Secretary General of the Chinese Pharmacopoeial Commission (ChP) usp.org | 3 Q & A with Roger Williams What kind of organization did you find when you started at USP in 2000? Was it what you expected? When I arrived at USP, I’d say the organization had been “McKinsey’d.” I use it as a verb, because USP had undergone an extensive evaluation by McKinsey & Company (the management consultancy) at the request of the Board of Trustees (BoT) to see how the organization was faring. The general sense was that it was not faring very well. There’s a phrase, “stick to your knitting,” and that’s something USP was not doing. The organization had done a number of things very well that were not our “knitting.” An example of this was our drug information publications. These products were ultimately sold to Micromedex, now Thomson Reuters, for $10 million. That helped a lot, but it wasn’t until four years later that the BoT exited from drug information altogether. In the meantime, USP’s core compendia, the United States Pharmacopeia–National Formulary (USP–NF), were suffering from neglect. There were many missing monographs, and many of the existing monographs were very much out of date. How would you characterize USP as it is today? What have been the most significant changes? As I talk about USP today, more than 13 years later, I’d still say that the USP–NF, still suffer from missing and outdated monographs. But there are big differences between 2000 and now: first, I understand what the backlog is; and second, I understand how we can close the backlog. Any discussion of missing and outdated monographs starts with identifying which medicines are legally marketed in the United States, which can be difficult to define. The estimated number is around 11,000. There are approximately 30 new entries each year, with about twice that number of dosage forms, which means a total of roughly 70 to 75 new entities annually. And FDA also removes drugs from the market each year for reasons of safety and efficacy. Do we remove those monographs from the compendia? We need to keep in mind that many of these drugs, even if no longer allowed for human use in the United States, are still used here for animals, and in humans and animals in other parts of the world. Because the USP–NF is global, there are more considerations than those that prevail domestically. The USP–NF is missing up to 5,500 monographs, while around 2,600 need to be updated. How can we fill these gaps? USP has embarked on an interesting experiment: the Medicines Compendium, which we launched in the summer of 2011. USP has learned that it can to create monographs and reference materials in its own laboratories, without relying on outside donors. This came to me in the past two years, and it had to be shown to me. Looking back, I should have seen this sooner; it’s important because the donor model has proven to be quite limited. Under the donor model, USP will never catch up to its backlog or modernize all its scientifically outdated monographs. What I call the “DIY” model can be robust, depending on resources of staff and equipment. If USP follows this model aggressively, the USP–NF could be complete in the next four to five years. What have been the biggest challenges that USP, and you, have faced during your tenure? When I speak of challenges, I also speak of opportunities, because the two are closely linked. One initiative that falls in both categories is USP’s attempt at globalization. “Globalization” has many meanings, depending on who you are and where you sit. For us, it comes down to understanding who is buying USP standards. During my time at USP, there has been a nearly complete reversal from almost entirely within the U.S. to primarily outside the U.S. And this relates to where drugs and their ingredients are manufactured now—most come from outside the U.S., and mostly from India. When I started at USP in 2000, there were voices on the BoT who thought USP should not extend its reach globally. They were mistaken, as has been clearly demonstrated. It was a challenge to overcome this reluctance, but well worth it. The Board’s decision to establish a facility in India was a smart one—I’d say that India is “where drugs are at” in 2013. Other challenges include the publication process of the USP–NF. I initially had what I’ve come to see as an almost humorous view of that process, which, I learned, takes a very long time. For a general chapter, it can be as much as two to three years, and for a monograph, around two years. Given the pace of drug innovation, this is really not workable nor in the interest of public health. Contrast this with FDA, which can turn around review and approval of a new drug in six months—and they’re criticized for slowness and backlog! Additionally, a big challenge for USP, as for any organization, is getting the right people and the right leadership—and the right processes. What are you most proud of when you look back at your time leading the organization? I’m very proud that USP has grown dramatically—four to five times, in terms of both staff and revenue—and that growth has accompanied and supported our global outreach. We have been successful overseas, we work with other pharmacopoeias, we have active working agreements with regulatory agencies and scientific bodies all over the world. We work closely with a global cadre of extremely sophisticated scientists, including those who have joined our expanded Expert Committee structure and our Convention membership. For me, personally, this has been most illuminating and gratifying. What advice would you give the next CEO? The new CEO will be a very fortunate person. He or she will take charge of an organization with a global footprint. USP is poised to build on the accomplishments of the past decade-plus, and with the help of the organization’s talented staff and dedicated volunteers the new CEO will be able to take full advantage of this strong foundation. I promise, he or she will learn and will grow in the process, as I have. g 4 | The Standard | Fall 2013 Science and Standards A Economically-Motivated Adulteration of Food Ingredients and Dietary Supplements Workshop Exusing a combination of carefully designed documentary standards, and appropriate reference materials, recent trends in spectroscopy and genetic methods to trace and detect adulteration, as well an overview of how other regions in the world are trying to deter adulteration. Speakers will include representatives from the FDA, USDA, Health Canada, academia and contract laboratories, as well as the Chinese National Center for Food Safety and Risk Assessment and industry representatives, including General Mills, Kraft Foods and Nestlé. A pre-workshop Pharmacopeial Education course on how to effectively use the Food Chemicals Codex (FCC) is being offered on September 25, 2013. Participants will learn how to effectively use food ingredient standards in the FCC and FCC Supplements. Included in the course curriculum are overviews on how FCC standards are developed and how to participate in the standards-setting process via the FCC Forum, USP’s free, online resource that gives FCC users a chance to review and comment on proposed changes to the compendium. For more information and to register to the workshop and to the preworkshop FCC course, please visit: http://uspgo.to/food-ds-workshop. g please cut headline dulteration of food ingredients and dietary supplements is an ongoing issue for manufacturers and consumers alike, as more ingredients are sourced globally and new, improved tests and techniques to detect adulteration are developed. The extent of adulteration, the emergence of promising detection techniques, and the role that quality standards can play in assisting industry and protecting consumers are among areas of focus for an upcoming workshop, “Economically-Motivated Adulteration of Food Ingredients and Dietary Supplements,” September 26–27, 2013, in Rockville, Md. The workshop is sponsored by USP and cosponsored by the Institute of Food Technologists (IFT), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA). “In the food and dietary supplement industries, manufacturers are constantly concerned about the quality of their ingredients and products, which are valued by consumers for their purported nutrition, health benefits, flavors or other characteristics,” said Dr. Gabriel Giancaspro, vice president for foods, dietary supplements and herbal medicines at USP. “As supply chains become more globalized, high-valued ingredients become constant targets for adulteration. This workshop will explore how public standards can help ensure the authenticity of such ingredients and serve all stakeholders in protecting the supply chain. This is an opportunity for an open forum to discuss the latest technologies used to keep the foods and dietary supplements free from adulterants in this country and abroad.” Among the workshop highlights are modern methods of analysis and techniques for detecting adulterants in foods and dietary supplements, an overview of the compendial role in preventing and deterring adulteration of food ingredients and dietary supplements, USP Global Education and Training Expanding Offerings and Technology Based on the ever changing needs of scientists, industry professionals, and healthcare practitioners around the world, USP Global Education and Training (formerly Pharmacopeial Education), will be expanding the current format from a face-to-face delivery model to a multi-delivery one that increases access to premium content. The new format will allow for content to be taught to students around the world in a variety of ways including, how-to videos, live webinars with question and answer segments, ondemand webinars, self-paced interactive courses, and courses that combine face-to-face and online offerings. A number of courses will also be offered at USP Headquarters in Rockville where construction on a new training laboratory will be completed soon. Additionally, USP is currently working on establishing partnerships with other trade and membership organizations to provide even more courses. More information and course listings can be found at: www.usp. org/meetings-courses/courses. g usp.org | 5 Science and Standards F First 2010–2015 USP Excipients Stakeholder Forum Held in June monographs with the Pharmacopoeial Discussion Group and other pharmacopoeias; and reference procedures applicable to drugs with different routes of synthesis. Ms. Catherine Sheehan, USP senior director of excipients, provided a historical and legal overview of USP–NF, discussed the enforcement role of the U.S. Food and Drug Administration (FDA) relative to USP’s standards setting role and stressed that stakeholders should become familiar with the Pharmacopeial Forum (PF) public comment and monograph submission processes. Ms. Sheehan also discussed the excipient track of presentations at the September Science & Standards Symposium (S3) in Baltimore and the halfday pharmacopeial education course on General Chapter <1059> Excipient Performance preceding the S3 meeting. Ms. Sheehan invited participants to suggest topics for a future USP Excipients Stakeholder Forum by completing the attendee evaluation form on the USP website. Dr. Steve Wolfgang of FDA shared perspectives related to the globalized excipient supply chain, the emergence and proliferation of threats to drug quality; the impact of substandard excipients on drug product safety and quality and the role of quality by design and end-user authenticity checks. Dr. Wolfgang also discussed the development of the American National Standards Institute—NSF International 363 Excipient Good Manufacturing Standard, which sets a baseline for certification of a quality management system approach. Dr. Wolfgang stressed the limitations of this standard and that a compendial monograph with improved standards for excipient testing can further promote quality by reducing variations in identity, composition and characterization. Representatives from the International Organization of the Flavor Industry, IPEC Federation, the BioPhorum Operations Group and the Industrial Minerals Association of North America gave brief overviews of their activities with USP. Additional speakers addressed the USP the Spectral Library project, excipient monograph modernization, excipient monographs in the Medicines Compendium, other USP–NF general chapters related to excipients as well as other relevant pharmacopeial education courses. For more information about USP’s Stakeholder Forums, visit: www.usp.org/meetings-courses/stakeholder-forums. g or the first time during its 2010-2015 cycle, USP hosted the Excipients Stakeholder Forum at the Rockville headquarters on June 7, 2013. More than 250 excipient manufacturers, pharmaceutical manufacturers, regulators and other stakeholders attended the forum in person or via WebEx. The forum is part of an organizational initiative to increase interactions with excipient stakeholders that manufacture, supply and use excipients for pharmaceutical purposes. The goals of the USP Excipients Stakeholder Forum were to provide stakeholders with an update on USP’s standards-setting processes and activities related to excipients, and to discuss other topics of interest related to excipients in an effort to encourage and receive stakeholder feedback on USP’s standards. Several monographs and general chapters related to excipients appear in USP’s compendia of standards, USP–NF. The forum is part of an organizational initiative to increase interactions with excipient stakeholders that manufacture, supply and use excipients for pharmaceutical purposes. The forum was chaired by Ms. Patricia Zawilak, representing the International Pharmaceutical Excipients Council (IPEC) Americas. USP chief executive officer, Dr. Roger L. Williams, provided an update on USP’s new standards on elemental impurities, discussing the deferral of the standards’ May 1, 2014, implementation date as well as the relationship of the new standards to the International Conference on Harmonisation Q3D Impurities: Guideline on Metal Impurities Step 2 document. According to Dr. Williams, USP has formed an Elemental Impurities Advisory Group that will address implementation requirements related to the new standards and their impact on manufacturers. USP will keep stakeholders informed through web postings on the Elemental Impurities Key Issues page (www.usp.org/usp-nf/key-issues/elemental-impurities). Executive vice president of global science and standards and chief science officer at USP, Dr. V. Srini Srinivasan, provided an overview of USP, including its mission; structure; the Global Science and Standards Division; and USP’s expanded laboratory capacity in India, China, and Brazil. Dr. Srinivasan gave an overview of key USP excipient initiatives including the development of new monographs; modernizing and redesigning existing monographs; harmonization of Join the Conversation. Follow USP on 6 | The Standard | Fall 2013 USP Hosts PNP Stakeholder Forum n June 11, 2013, USP hosted the Prescription/Nonprescription (PNP) Stakeholder Forum at its headquarters in Rockville, Md. The PNP Stakeholder Forum provides USP with an opportunity to share updates on topics of interest to manufacturers of prescription and nonDr. Vinod Shah of USP presents prescription medicines and during the PNP Stakeholder Forum. to gather valuable feedback from stakeholders. Participants from industry, the regulatory community and pharmacopeial organizations attended the forum, in person or via the web. USP stakeholder forums play a key role in the exchange of information and perspectives that help USP develop and improve its standards. After welcoming remarks from Dr. Elaine Vandenberg, PNP chair representing the Calibration and Validation Group, and Dr. Roger Williams, USP’s chief executive officer, Dr. Shawn Dressman, vice president of chemical medicines, presented on USP’s monograph development process based on monograph donations from external sources. Dr. Benham Davani, director of monograph modernization, described USP’s ongoing modernization activities for USP–NF monographs, which includes expansion of USP’s laboratory capabilities to support these efforts. O Acting senior vice president for global laboratory operations, Dr. Hermes van der Lee, gave an overview of USP’s U.S. and global laboratory capabilities. Dr. van der Lee discussed research and development, reference standards evaluation and characterization, and reference standards production laboratories in U.S., Brazil, China and India, and their roles in supporting monograph development and modernization as well as reference standards development. Ms. Shawn Becker, director of healthcare quality standards (HQS), discussed ongoing work by USP Expert Committees and Expert Panels on hazardous drugs and compounding for investigational studies, along with several other new initiatives emanating from the HQS group. Other presentation topics included general chapters on validation and verification and regulatory perspectives on these chapters; pharmacopeial and monograph harmonization; an update on USP’s new general chapters on elemental impurities; USP’s Mid-Cycle Meeting for volunteer groups and Pubs 2.0 (UPS’s new publication platform). Dr. Williams presented on a new model for developing harmonized standards based on reference procedures. USP consultant, Dr. Vinod Shah, discussed USP’s general chapters on dosage forms. Updates were also provided to the stakeholders from the General Notices Project Team as well as the Compendial Improvements Project Team of PNP. For more information about USP’s Stakeholder Forums, go to: www.usp.org/meetings-courses/stakeholder-forums. g T USP Revises General Chapter <771> Ophthalmic Ointments to Include All Dosage Forms that Can Be he anatomy and physiology of the eye make it one of the most complex systems in the human body. While its many innate barriers offer protection against the invasion of undesired molecules, pathogens and particulates, they pose a challenge to the delivery of ocular drugs. Ophthalmic drug delivery is used only for the treatment of local conditions of the eye and cannot be used as a portal of drug entry to the systemic circulation. Topical application of drops, ointments, gels and emulsions to treat diseases in the anterior segment of the eye (different layers of the cornea, conjunctiva, sclera, iris and ciliary body) continues to be a popular method because of the ease of administration and low cost. The advancement of technology has increased the options of dosage forms applied to the eye, from the most commonly used (solutions, suspensions, ointments, gels, emulsions, injections, inserts and implants) to novel applications, such as colloidal systems (with please cut headline controlled release of drugs to the targeted site through nanoparticles and microemulsions); hydrogels (three-dimensional, hydrophilic networks capable of taking large amounts of water or biological fluids); microneedles (drug-coated dissolving needles that can easily be removed after the drug is administered); ultrasound (currently being studied to deliver beta-blockers across the cornea in the treatment of glaucoma); and other non-invasive methods designed to deliver drugs to intraocular regions. USP General Chapter <771> Ophthalmic Ointments currently addresses some parameters and characteristics only for ophthalmic ointments, including added substances, containers, metal particles and leakage. In an effort to modernize the general chapter, and align it with other USP general chapters related to pharmaceutical dosage forms, USP is revising General Chapter <771> to cover all Continued on page 15. See General Chapter <771> Revision usp.org | 7 Science and Standards SP is proposing new quality standards, or monographs, in its Food Chemicals Codex (FCC) 9th Edition, for Spirulina, Brilliant Black PN and a new FCC Identity Standard developed for Pomegranate Juice. The new FCC Identity Standards not only provide tests that focus on the confirmation that a product is what it purports to be, but also tests for substances that should not be found in an authentic product, therefore indicating adulteration. Manufacturers and other parties provided comment on (bad these proposals in the most recent FCC Forum (www.usp.org/fcc/ link) fccForum.html)—the free, online vehicle for the public to review and comment on draft FCC standards. “USP’s public standards in the FCC define the identity, quality and purity of food ingredients,” said Dr. V. Srini Srinivasan, USP’s executive vice president for global science and standards and chief science officer. “These can be an important resource for manufacturers as they source ingredients from suppliers around the world, offering assurance that they are receiving what they expect. The new FCC Identity Standards take food safety one step further, not only describing a food ingredient, but testing for components that could help manufacturers and formulators make sure their ingredients are not adulterated. ” Highlights of the FCC Forum for the period of June–September, 2013 included: • Pomegranate Juice—Pomegranate juice is obtained from the arils of the pomegranate fruit (Punica granatum), which may be filtered, treated with pectinase enzymes for clarification and pasteurized. The FCC Identity Standard for pomegranate juice gives users a description of the ingredient as well as a series of identification tests and acceptance criteria. Geographical and seasonal variations were taken into consideration in development of the standard, and a series of tests for substances that should not be present in pomegranate juice (e.g., sorbitol and tartaric acid). Candidates for other FCC Identity Standards in the future are high-cost, high-demand ingredients, such as cinnamon, paprika and bay leaves, which could help manufacturers and formulators test source materials they intend to use in their food products. FCC Identity Standards should be considered informational only and should not be confused with FCC monograph specifications. Food ingredients for which an FCC monograph exists will not be included in the Identity Standards section of FCC. • Spirulina—Spirulina is the dried biomass of the cyanobacterium Arthrospira platensis. Rich in protein (up to 60% of its contents), spirulina is considered safe for consumption by humans and animals, and it has been cultivated and used as a food source worldwide. The U.S. Food and Drug Administration (FDA) has not questioned the basis for the Generally Recognized as Safe (GRAS) designation to spirulina under the conditions of its intended use, thus restricting it as a food additive in amounts that U New Standards for Pomegranate Juice, Spirulina and Other Food Ingredients Proposed for FCC range from 0.5 to 3.0 grams per serving. Formulators use spirulina in specialty food bars, powdered nutritional drinks, popcorn, beverages, fruit and fruit juices, frozen desserts and condiments. For regulatory compliance and formulation considerations, it is critical for manufacturers to be able to accurately identify the material they have sourced. The new USP monograph has a specific test to ensure the absence of microcystins – toxins produced by certain types of cyanobacteria that may lead to severe liver damage. When cultivated and harvested under controlled conditions, the growth of other cyanobacteria is prevented, which subsequently averts the production of microcystins. The presence of microcystins indicates that the ingredient has either been adulterated with lower cost, microcystins-producing types of cyanobacterium, or that cultivation has not been done according to Good Manufacturing Practices. • Brilliant Black PN—This synthetic food color is used in products requiring the color black in their formulations (e.g., jams, chocolate syrup, candies). FDA has not approved this color for use in food in the United States but it has been approved in other countries. Because the FCC is a global compendium, it includes monographs for ingredients such as food colors that are used widely and considered safe in other countries. One challenge in testing synthetic colorants is the measurement of impurities and the availability of reference materials for those impurities. USP is developing new reference standards for the impurities proposed in the monograph for Brilliant Black PN to support this need, allowing more accurate testing and ultimately helping provide a better safety profile for this ingredient. The issue of the FCC Forum for the period of June to September 2013 has been reformatted to provide greater ease-of-use and enhanced functionality. The new FCC Forum will include additional search options, highlighted search results for easy viewing, the ability to click through and preview search results. For more information about the FCC and the FCC Forum, visit: www.usp.org/ food-ingredients/ food-chemicalscodex. g 8 | The Standard | Fall 2013 USP Officials Visit Vietnam and Korea U SP officials visited Vietnam and Korean in June to participate in the 3rd ASEAN-USP Scientific Symposium in Hanoi, Vietnam, and to meet with the Korean Ministry of Food and Drug Safety (MFDS—formerly Korean Food and Drug Administration). The ASEANUSP collaboration began in 2009, under a technical cooperation agreement. The organizer of the 2013 symposium was the Vietnamese Ministry of Health, through the National Institute of Drug Quality Control. The theme of the meeting was “Strengthening Regional Collaboration to Ensure Quality of Pharmaceuticals.” Nearly 200 representatives of drug regulatory agencies, official medicines control laboratories, academia, pharmaceutical manufacturers and other stakeholders attended, including representatives from all four ASEAN Region pharmacopoeias―Vietnamese, Indonesian, Philippine, and the Thai Herbal Pharmocopoeia. For the first time, the ASEAN Secretariat, Ms. Jintana Sriwongsa, attended an ASEAN-USP Symposium. Symposium presentations included overviews of the Vietnamese and Philippine pharmacopoeias; ASEAN reference standards; research on extraction, isolation and purification of natural compounds to establish reference standards for quality control of medicinal materials and herbal medicines in Vietnam; microbial test methods; and monitoring of antibiotic, anti-malarial and anti-tuberculosis medicines in Laos. A Vietnamese Stakeholder Forum was held after the symposium, where USP’s CEO Roger L. Williams offered an overview of USP’s products and services, and USP’s vice-president for international business development, Ed Zhao, provided an overview of USP’s allied compendial programs. Mr. Tran Kim Thoan, director of quality management for Vietnamese PYMEPHARCO, presented an overview of quality control for global standards from Vietnamese pharmaceutical manufacturers. Pharmacopeial Education courses were also held for approximately 100 attendees on dissolution testing, validation and verification of analytical procedures, and USP Reference Standards. USP’s delegation also traveled to Korea for meetings to advance the relationship with MFDS and the revision of a memorandum of understanding (MOU) signed between with USP and MFDS in 2012. The meeting to revise the MOU included discussions about in three areas: chemical drugs, biologics and medical devices. Proposed changes to the MOU (currently under review by MFDS) would also enable broader standards-setting collaborations. The same Pharmacopeial Education courses held in Vietnam were offered in Korea for 72 participants, including members of MFDS. This was the first time manufacturers had the opportunity to personally interact and engage with USP scientists. USP encouraged MFDS to attend the upcoming Global Summit of the Pharmacopoeias in September, 2013, in Baltimore, Md., and asked MFDS to appoint members for USP Expert Committees, as well as name a delegate to the 2015 USP Convention meeting. g USP delegation and Korean officials work on the revision of an MOU signed in 2012. usp.org | 9 Science and Standards T Science & Standards Symposium in São Paulo he 2nd Annual USP-Brazil Science & Standards Symposium in São Paulo, “Partnering Globally for 21st Century Medicines,” took place on July 25–26. Attended by 400 regulators, academicians, pharmaceutical manufacturers and quality assurance and control experts from Brazil and other Latin American countries as well as the U.S., the meeting focused on quality standards for chemical and biological medicines as well as globalized approaches to developing quality standards. “It is critical for organizations that support global health—manufacturers, regulators and pharmacopoeial groups alike—to maintain an ongoing dialogue on best approaches for establishing and harmonizing standards for medicines that help safeguard health regionally and throughout the world,” said Dr. Roger L. Williams,, chief executive officer of USP. “As the global industry and medicines themselves become more complex, we need standards to help ensure that the quality of all medicines is well protected.” According to Dr. Mônica Co-sponsors of the meetSoares, Brazilian Pharmacoing were Brazil’s National poeia coordinator at ANVISA, Health Surveillance Agency “Meetings like the Science (ANVISA)/Brazilian Pharma& Standards Symposium and copoeia, the University of partnerships with organiSão Paulo School of Pharmazations such as USP give ceutical Sciences, the São Dr. Monica Soares, Brazilian Pharmacopeia Coordinator at ANVISA, Prof. Dr. Filipe those of us responsible for Paulo Pharmacy Council, the Soares Quirino Silva, Head of Chemistry Department at INCQS, Dr. Roger Williams protecting the supply of Federal University of Minas and Prof. Dr. Gerson Pianetti, Brazilian Pharmacopeia, Commission President medicines in Brazil and other Gerais School of Pharmacy, Latin American countries a the Foundation for Popular chance to learn from one another about the challenges we share Medicines and the National Academy of Pharmacy. The meeting and generate solutions for addressing those challenges.” marked the first time that ANVISA has co-sponsored a USP scientific meeting in Brazil, underscoring the importance of multi-national relationships among health organizations. Continued on page 15. See S3–São Paulo 2013-2014 USP Global Fellowship Awards U SP has awarded three Global Fellowship Awards for the 2013– 2014 academic year. The Fellowships are for research focusing on a portable method for counterfeit drug analyses, the development of monographs for human immunodeficiency virus infection/acquired immunodeficiency syndrome (HIV/AIDS) medicines used to treat cases of resistant infections and the use of speciesidentification assays in adulterated products. The goal of the USP Global Fellowship Awards is to advance research that contributes to innovative or updated quality standards for medicines, food ingredients and dietary supplements, and to support the work of early career scientists in these fields. The $50,000 Global Fellowship Awards recognize research that directly address a specific USP scientific or research need. Since the program’s inception in 1981, USP has invested nearly $4 million in over 200 Fellowship awards. Each of the following students has received a $50,000 USP Global Fellowship award for the 2013–2014 academic year: Adam L. Kaylor, Ph.D. candidate, Georgia Institute of Technology Area of Research – Development of a new pulsed plasma ion sources for counterfeit drug analyses by portable ion mobility spectrometry and rapid liquid chromatographymass spectrometry Haichen Nie, M.S., Purdue University Area of Research – Sustainable medicines for Africa—Development of monographs and associated knowledge to increase access to HIV/AIDS medicines for resistant infections (Darunavir-Ritonavir) Sharla M. Peters, Postdoctoral candidate, Howard University Area of Research – Development of a multiplex real-time polymerase chain reaction assay for the detection of ruminant material in adulterated products Details about the USP Global Fellowship Awards are available at: http://uspgo.to/ fellowship-awards. g 10 | The Standard | Fall 2013 T First USP Workshop on Host Cell Impurities in Biotechnology Products Co-Hosted by BEBPA echnological, regulatory, and clinical issues related to residual host cell impurities in biotechnology-derived products were the focus of a workshop co-sponsored by USP and the BioPharmaceutical Emerging Best Practices Association (BEBPA). The workshop, “Measurement of Residual Host Cell Protein (HCP) and DNA in Biotechnology Products,” took place on June 3–4 and was the first USP has held on this topic. Modern biological therapies such as monoclonal antibodies and therapeutic proteins made through recombinant techniques rely on host cells such as E. coli or Chinese hamster ovary cells for their production. Residual host cell impurities are unwanted proteins or DNA from the manufacturing cell substrate that remain in a final product after purification. The workshop featured two days of presentations from industry, academic, regulatory and pharmacopeial stakeholders covering regulatory considerations and platform approaches for the measurement of residual DNA and HCPs; HCP assay and reagent qualification issues; emerging technologies; and pharmacopeial development of best practice standards for measuring residual DNA and HCP. One of the most popular discussion topics for the meeting was the concept of HCP coverage. A host cell can express many types of proteins, and methods for measuring residual impurities need to be sensitive enough to identify HCPs against a backdrop of other proteins already abundant in a drug product. It is important that an assay is actually detecting—or “covering”—most of the HCP proteins in a mixture, and advantages and disadvantages of different methods (e.g., ELISA versus two-dimensional electrophoresis, etc.) were explored. Platform approaches for measuring residual HCP were also discussed. Developed mostly within large biopharma companies, platform approaches use the same cell lines and cell culture conditions over a range of products. This aids in the development of a set of critical reagents that can be used to measure HCPs in multiple purification stages and products that use common platforms. Workshop speakers included representatives from the U.S. Food and Drug Administration, the Paul Ehrlich Institute (Germany), Amgen, Covance, Genentech, Biogen, University of Rhode Island, University of Notre Dame, Waters Corporation, Novartis Pharma AG, Pfizer, and Janssen/Johnson & Johnson. Workshop attendees also heard from USP’s Expert Panels on standards-setting activities related to measurement of residual HCP and DNA in biotechderived products. Two new general chapters for the measurement of residual HCP and DNA impurities are planned for publication in Pharmacopeial Forum in 2014, and the speakers encouraged the biopharmaceutical manufacturing community to comment when they appear online. g Highlights of Upcoming USP Workshops Cell and Tissue-based Regenerative Medicine Products: From Characterization to Compendial Assays November 7–8, 2013 Cell therapy and tissue-engineered products represent a growing segment of the biotechnology industry. However, the development, clinical translation and marketing authorization of these products faces many challenges, including the lack of established quality attributes to define and assess the finished products. Living cells, unlike classic pharmaceutical products, have the potential to change their properties during manufacturing—sometimes intentionally, such as through differentiation; in other cases unintentionally, such Currently, USP–NF contains tissue monographs describing assays that have been developed and validated to ensure that a specific process yields a product with the necessary quality attributes. In some cases, these assays have not been correlated to clinical outcomes, since the majority of these products are not required to undergo clinical trials prior to marketing. Only a few cell therapy products are approved through the Biologic License Application pathway, with many more under development and pending regulaContinued on page back cover. See Upcoming Workshops as through loss of functional activity. This creates a challenge for characterization and standardization. usp.org | 11 Global Health Impact Programs please cut headline CePAT’s First Group of Students Successfully Complete Course Module on Medicines Dossier Eval- CePAT’s trainees from six countries in Sub-Saharan Africa finish the dossier evaluation training module in Ghana. July, 2013. N ational regulatory frameworks for pharmaceutical products vary greatly among countries, as does their degree of technical capacity to carry out dossier evaluations that adequately assess the safety, quality, and efficacy of medicines. One of the goals of USP’s newly launched Center for Pharmaceutical Advancement and Training (CePAT), in Accra, Ghana, is to address deficiencies in regulatory frameworks in developing countries in Sub-Saharan Africa. On July 8, 2013, CePAT offered the first module of dossier evaluation training to regulatory authorities of six African countries (Ghana, Ethiopia, Sierra Leone, Kenya, Nigeria and Senegal), including case studies to illustrate important concepts and thereby help build the necessary knowledge and skills in dossier assessment and registration of medicines. Some of the highlights of the two-week training course involved an introduction to medicines dossier evaluation and a review of basic concepts, including general information, specifications, control and stability of drug substances; analytical methods and method validation; and product dossier assessment in common technical documents. C. Patricia Alsup, Deputy Chief of Mission for the United States Embassy in Ghana, presented the certificates of participation in the training in a ceremony also attended by Dr. Stephen K. Opuni, chief executive officer of the Ghana Food and Drugs Authority. “CePAT is one of the most important initiatives to ever be implemented in this part of the world, as it goes deep into the root problem of lack of quality medicines in Africa, which is insufficient human resource capacity,” said Dr. Opuni. “Training the regulatory bodies in Africa so they can apply what they see and learn at CePAT within their own agencies and train their peers to bring sustainability to those agencies is a very important step in offering better medicines and ultimately better health to our populations.” The dossier evaluation class will come back for the second part of the training module in the spring of 2014, to report how they have used the information they learned at CePAT in their national regulatory agencies, and to start the advanced training module, where they will focus on topics involving clinical trials, biologics and vaccines manufacturing and validation and bioequivalence of medicines. CePAT will offer two other training modules on Good Manufacturing Practices (GMP) and Quality Assurance, starting in September 2013. For more information about CePAT’s courses and eligibility criteria, e-mail:
[email protected]. g 12 | The Standard | Fall 2013 P Regional Training in Latin America Helps National Labs Control Medicines Quality QM conducted a laboratory training workshop at Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia’s official medicine control laboratory (OMCL), for 13 analysts from the OMCLs of Brazil, Colombia, Ecuador, Guyana, Peru and Suriname. The hands-on workshop focused on analysis of Artemether-Lumefantrine (Coartem®), a fixed-dose combination medicine used as the first-line treatment for malaria in those countries. The training covered practical aspects of high performance liquid chromatography (HPLC), dissolution and thin-layer chromatography (TLC) analysis. Being able to perform these laboratory techniques independently will help the OMCLs sustain their medicines quality control systems. Throughout the workshop, PQM trainers encouraged the participants to practice the techniques and ask any questions that arose. By the closing ceremonies, the trainees were able to perform HPLC assay, dissolution, and TLC procedures according to pharmacopeial standards and evaluate the quality of antimalarial products using available public standards. In order to reinforce the analytical methods learned during the workshop, PQM is sending additional samples to the trainees so they can perform the analyses on their own. The results of those quality control tests will be forwarded to PQM for review, comment, and further instruction, as needed. The workshop was jointly organized by PQM, INVIMA and the Pan-American Health Organization with funding from the Amazon Malaria Initiative (AMI) through USAID. g Representatives of OMCLs in Brazil, Colombia, Ecuador, Guyana, Peru and Suriname participated in the training that covered HPLC and TLC analyses. Senegal Regulators Recall Five Lots of ACTs The Direction of Pharmacies and Medicine (DPM), Senegal’s medicines regulatory authority, recalled, in June 2013, five different lots of Artemisinin-based combination therapy (ACT) medicines based on results of medicines quality monitoring (MQM) data collected in collaboration with USP’s Promoting the Quality of Medicines (PQM) program. The samples of combinations of Artemether and Lumefantrine, and Artemether and an unidentified substance were collected during routine post-marketing surveillance from around the country, screened for quality using Minilab© basic tests, and confirmed as substandard through compendial testing at the medicines quality control laboratory, Laboratoire National du Controle des Medicaments (LNCM). Supported by DPM, new management at the LNCM has promptly imposed regulatory actions against violators. The official recall notices for these ACTs were sent to the companies involved, wholesalers, and the National Supply Pharmacy. Reports on the products in question were also shared with USAID, national disease control programs, regional chief doctors, and other health departments. In addition to the MQM program, PQM has been helping the LNCM prepare to apply for ISO 17025 accreditation. On a recent trip to Dakar to qualify several pieces of lab equipment, LNCM director Pr. Yerim Diop expressed his appreciation for the technical assistance PQM has provided, crediting it for the progress the lab has made towards accomplishing its goal. Because of the advances the lab has made, LNCM is planning to submit a proposal to get their Microbiology and Vaccine laboratories prequalified by the World Health Organization (WHO) Prequalification Programme. g usp.org | 13 Inside USP USP Announces New Senior Vice President of Development USP is pleased to announce the appointment of Dr. Michael D. Maves as senior vice president of development. Dr. Maves brings a depth and breadth of medical, global health and management experience to this newly-created position at USP, which is designed to extend the organization’s standards-setting expertise into the worldwide philanthropic arena. Dr. Maves, who previously served on USP’s Board of Trustees, has resigned that position to take on his new responsibilities. “I’m delighted that Mike Maves has accepted this key, strategic role,” said Roger L. Williams, M.D., USP’s chief executive officer. “He is uniquely qualified to lead USP’s initiatives in development, and in the execution of capacitybuilding activities in resource-constrained parts of the world. His understanding of USP’s please mission as a global standards-setting organization from his time on our Board builds on his cut extensive experience as a physician, teacher, global health leader and visionary executive.” Dr. Michael D. Maves 2-3 lines On-Demand Webinars Provide Resolution Updates At each five-year USP Convention Membership meeting, delegates adopt resolutions to help guide USP’s strategic direction. Led by Convention President Dr. Tim Franson, USP produced a series of four “town hall” webinars to update our members and other interested parties on the progress of the resolutions adopted in 2010. During the series, attendees heard updates on the following resolutions: • Strengthen focus on core compendial activities (Resolution 2) • Strengthen USP’s relationship with the U.S. Food and Drug Administration (FDA) (Resolution 3) • Support and advance global public health initiatives (Resolution 4) • Strengthen and expand harmonization efforts (Resolution 5) • Continue and expand commitment to quality standards for food ingredients (Resolution 6) • Promote availability, use and recognition of quality standards for dietary supplements (Resolution 7) • Develop, maintain and promote adoption of quality standards for compounded medicines (Resolution 8) • Explore development of quality standards of value to practitioners and the public (Resolution 9) Dr. Franson introduced each topic, and USP staff shared progress toward each resolution, and answered audience questions. In addition to nearly 80 online attendees who participated in the live sessions, recordings have been viewed more than 150 times on YouTube. You can view the recorded webinars on the USP website at www.usp.org/membersoverview/town-hall-webinars, or on YouTube. g Dr. Maves, a board-certified surgeon, served most recently as the executive vice president of Project HOPE, a global nonprofit health education and humanitarian assistance organization with more than 400 employees worldwide and programs in more than 35 countries. Prior to that, he was executive vice president and chief executive officer of the American Medical Association (AMA), the largest medical professional association, representing nearly 225,000 physician members. Dr. Maves came to the AMA after serving as president of the Consumer Healthcare Products Association, the major U.S. trade association representing manufacturers of over-the-counter medicines and dietary supplements. Earlier in his career, he led the American Academy of Otolaryngology–Head and Neck Surgery; chaired the Department of Otolaryngology at the Saint Louis University College of Medicine; and served as professor and leader of medical departments at a number of universities and military divisions. USP Announces New Acting Chief Operating Officer USP is pleased to announce the promotion of Richard Wailes to the position of acting executive vice president and chief operating officer of the organization. Mr. Wailes is advancing from vice president of sales and marketing, a position he has held since 2002. In his new role, he will continue to oversee the sales, marketing and customer service operations, and adds responsibility for information services; finance, accounting and treasury; and global communications. Mr. Wailes joined USP in January 1999 as director of human resources. He was promoted to vice president, human resources and client services in 2000. Prior to joining USP, he had experience in sales and marketing, operations, and human resources at Fortune 500 corporations, including IBM, Avery Dennison, WellPoint Health Networks, and Thermo Electron. Richard Wailes Mr. Wailes earned an M.B.A. at Harvard Business School and a B.A. in American studies from Amherst College, magna cum laude. g 14 | The Standard | Fall 2013 The Standard International Training Program Continued from front cover Liberia, for example, has had a long relationship with USP that started through the Promoting the Quality of Medicines Program (PQM), which helped them establish their regulatory framework. The Liberia Medicines and Health Products Regulatory Authority (LMHRA) also received assistance from USP’s TAP program (Technical Assistance Program), and with funding from other international development agencies, the country was able to establish a sustainable medicines control program and is working towards WHO (World Health Organization) Prequalification and ISO Certification of their national Quality Control lab. “We were pleased to improve our understanding of USP’s scope and its involvement in aspects of medicines quality,” said Dr. David Sumo from LMHRA. “With ITP we deepened our knowledge about what USP does and we hope to strengthen our relationship with USP’s scientists so we can offer better access to quality medicines to Liberians.” A second delegation of international regulatory authorities and national reference lab professionals from Latin America, Middle East and Africa is schedule to visit USP for another ITP session in the fall of 2013. For more information about the program to hear what other participants had to say about their experience at USP, visit: http://uspgo.to/itp. g (bad link) ITP presentation from Gambia representative, Ms. Janneh Markieu. General Chapter <771> Revision Continued from page 7 dosage forms that can be applied to the eye. The revised version, General Chapter <771> Ophthalmic Preparations—Quality Tests, will also include appropriate quality tests. Dissolution and drug release tests pertaining to all of these dosage forms will be included in the new General Chapter <1771> Ophthalmic Preparations—Performance Tests. A stimuli article to the revision process, titled Ophthalmic Preparations is available for comment in Pharmacopeial Forum (PF) 39(5) [September–October 2013]. The article presents the rationale to support the general chapter revisions and contains a description and characteristics related to novel dosage forms, container closure systems, drug product quality tests and performance tests, dissolution and drug release tests. To clarify aspects of the proposed revision to both General Chapter <771> and General Chapter <1771>, and to bring together stakeholders who work with ophthalmic preparations for human and veterinary use, USP is holding a workshop on October 21–22, 2013 at its headquarters in Rockville, Md. Other topics included in the workshop are formulation approaches to overcome barriers in the eye, microbiological requirements (sterility, antimicrobial effectiveness, bacterial endotoxins), critical quality attributes of ophthalmic dosage forms (particulate matter, leachables and extractables), stability requirements and dissolution and drug release from modified dosage forms. For more information about the workshop, (bad the most recent agenda and registration, visit http://uspgo.to/ophthalmicpreparations. g link) S3–São Paulo Continued from page 10 Emphasizing global partnerships for standards development and harmonization, presentations addressed topics such as: • Using a comprehensive monograph and more modern understanding of in vitro dissolution to reduce regulatory burden • Quality determination of modern biologic medicines including monoclonal antibodies, heparin, and tumor necrosis factor • New approaches for developing global public quality standards, such as the Medicines Compendium (MC), and working in partnership with all national pharmacopoeias • USP standards for impurities in medicinal ingredients and products • Standards for first and subsequent entry non-interchangeable biologics, biosimilars, and interchangeable biosimilar medicines. Prior to the start of the symposium, a ribbon-cutting ceremony marked the recent expansion of USP-Brazil’s laboratory site in São Paulo. Established in 2008, USP–Brazil is one of USP’s four global laboratory facilities, which also include Shanghai, China; Hyderabad, India and Rockville, Md. (U.S. headquarters). The expansion at USP–Brazil will increase the organization’s capabilities to update and modernize standards appearing in U.S. Pharmacopeia and the National Formulary (USP–NF). USP-Brazil also is developing standards for the MC. g usp.org | 15 Upcoming Workshops Continued from page 11 tory approval. The quality attributes of both cellular and decellularized products vary from one product to another, and molecular markers are often used as a surrogate to determine identity, purity, or potency. This workshop aims to bring together key stakeholders from industry, academia, and government to identify opportunities and challenges in defining relevant and appropriate characterization assays for cell and tissue-based products, to establish priorities, and to identify assays that are ready for inclusion in USP–NF. For more information, visit: http://uspgo.to/cell-tissue. Headquarters 12601 Twinbrook Parkway Rockville, Maryland 20852 U.S.A. +1-301-881-0666 1-800-227-8772 (U.S. and Canada) 00-800-4875-5555 (Select Europe) Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables December 9–10, 2013 Plastic packaging systems for pharmaceutical products should adequately protect the product, be compatible with the product, and be composed of materials that are safe for use. From a chemical perspective, ingredients from a pharmaceutical product should not be absorbed onto the surface or into the body of the plastic packaging system. Furthermore, the packaging system should not release substances that can accumulate in the pharmaceutical product in quantities sufficient to affect its stability or to present a risk of toxicity. To this end, USP is proposing the revision and development of a suite of plastic packaging system standards that will publish in Pharmacopeial Forum (PF) 39 (5) [September–October 2013]. The PQRI Extractables and Leachable Working Group is also working to develop guidelines, specifically for packaging systems used for parenterals and ophthalmic drug products. The purpose of this workshop is to bring stakeholders together to discuss and collect feedback on the new standards and recommendations by both organizations. For more information, visit: http://uspgo.to/extractables-leachables. Europe/Middle East/Africa Münchensteinerstrasse 41 CH-4052 Basel, Switzerland +41 (0)61 316 30 10 USP–India Private Limited IKP Knowledge Park Turkapally Village Genome Valley Shameerpet, Ranga Reddy District Hyderabad 500 078, A.P., India +91-40-4448-8888 USP–China Building 11 Lane 67, Libing Road Zhangjiang Hi-Tech Park 201203 Shanghai China +86-21-51370600 <1> Injections and Implanted Drug Products (Parenterals)— Product Quality Tests December 16, 2013 USP taxonomy categorizes dosage forms according to five routes of administration: injection, oral, topical-transdermal, mucosal and inhalation [see Stimuli article in PF 29(5)]. USP’s goal for USP–NF is to have good drug substance and product monographs for all legally marketed medicines (drug products) and their ingredients in the U.S. To support a drug product monograph, USP has divided the tests of a monograph into two categories: product quality tests and product performance tests. Both arise from an understanding of critical quality attributes for a named article. For each route of administration, USP has/will create two general chapters: one that provides product quality tests that can be called out in a monograph, and one that provides one or more product performance tests that also can be called out in a monograph. Based on these considerations, USP–NF General Chapter <1> Injections is being completely revised to contain only product quality tests, PF 39 (5) [September–October 2013]. This webinar/workshop aims to bring stakeholders together to discuss the proposed revision to General Chapter <1> and collect feedback. For more information, visit: http://uspgo.to/general-chapter-1-workshop. g USP–Brazil Avenida Ceci, 1600 - Tamboré Barueri-SP 06460-120 Brazil +55-11-3245-6400 www.usp.org Copyright © 2013 The United States Pharmacopeial Convention. All Rights Reserved. GA070NL_2013-08