Update on Schedule l1

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Upcomming Articles: FDA regulations clinical trials, FDA validation guidelines, 21 cfr part 11 compliance, GMP compliance, FDA compliance, FDA audit, Pharma manufacturing, Regulatory affairs, Medical device validation, GMP validation, 21 cfr part governmental testing houses. 780(E) dated 10th November 2008 under Schedule “L-1” with effect from the 1st day of November. forty. UK and Japan formulated their national GLP standards. Clinical trial FDA. 1978 under the Title 21 of the Code of Federal Regulations as Part 58 (21 CFR 58).R. Water system.In the During the late 1970s and early „80s. 2010. Around the world.fourth report as Annex 1: WHO good practices for pharmaceutical quality control laboratories. study conduct and reporting. World Health Organization adopted GLP in its thirty-sixth report in 1999 as Good practices for national pharmaceutical control laboratories . HPLC Method Validation. 1979. and these GLP regulations came into effect on June 20. 2010. 1WHO issued guidance in WHO Technical Report Series.S. but the detection of outright fraud in such “studies” finally led to the development of formal principles of Good Laboratory Practices. Regulatory affairs. made GLP mandatory vide G. The Netherlands. Regulatory compliance. In a view to extend the guidelines for national control laboratories. Government of India. No. commercial drug manufacturer‟s testing lab and other non. .com here partner-pub-8715 UTF-8 Search Custom Search Update on Schedule L1 Share Update on Schedule L1 of Drug & Cosmatic Act 1940 Introduction In the historical context it had been observed that the laboratory data submitted (for registration of chemicals like drugs. 957. pesticides.clinical Laboratories in the Federal Register on December 22.820. and others) to the regulatory authorities were of mediocre quality with respect to study design. Validation Control. Not only this lack of quality. where the „(promotion of) development and maintenance of good laboratory practices in testing‟ had been made a task of the Council of Testing Laboratory Registration. HVAC validation. USFDA published Good Laboratory Practices for non. Switzerland. its first official use can be found in the 1972 New Zealand -Testing Laboratory Act. FDA validation. Search pharmaguideline. is to assure the quality. integrity and reliability of the laboratory data so that there is always an mutual recognization of the results among laboratories. analyst and technical staffs. Amongst these. commercial drug manufacturer‟s testing lab and other non. others are desired to posses suitable experience and qualification for their assigned duties.The basic purpose of all GLP. The laboratory management will hold overall responsibility for the technical operations. Material: 1. . Here in this article. there are differences in the strictness (or horizon) of the rules. Applicability : As stated earlier in the Introduction section. The head of laboratory is termed alternately as SUPERVISOR and clearly is intended to do work of laboratory overall management. The qualification requirement of the head of laboratory is only defined. The hierarchical requirements as per Schedule L1 is represented under figure 3. 1WHO clearly states its applicability for non. The picture can be visualized as (in fig. It distinctly applies to QC laboratory of licensed pharmaceutical manufacturers and their loan licensing units and Laboratory of licensed drug testing houses. namely lab management.governmental testing houses. the technical manager (Hopefully head of technical management and hence technical processes) is a delegated task.clinical testing in national control laboratories. 1940.1). Probably the laboratory itself needs to define its own requirement. The qualification requirements along with roles and responsibilities are clearly defined at every stage in this Guideline. laboratory overall management There is an additional requirement of a Quality Manager. Government Of India. we limit our focus between the rules laid by WHO versus those of Schedule L1. Effort is maximum to cover the important and noteworthy differences between the two. 2. technical management. who will have a direct access to the highest level of management at which decisions are taken on laboratory policies or resources. Hierarchical Requirements: WHO demands the existence of mainly four categories of personnel in a lab. but its applicability for national control laboratories or biological testing houses is not clear. In other words. developed by WHO or nations worldwide. Whereas 2Schedule L1 is not much clear regarding this. Drugs and Cosmetics Act. Such evaluation will provide confidence on the status of compliance of the data from statistical point of view. Without validation studies the answer to these may be not found out. 8OMCL guidelines are a good reference to identification and measurement of uncertainty. but shows an occasional deviation from the normal trend of result. As normally it is not a practice to repeat each test until there is any occurrence of any OOS (out of specification) or OOT (out of trend) test result. verification is a cut. there is always a chance that the data obtained is not a true value.short validation process with . Systematic investigation of such result may act as a corrective and preventive action for any failure in the entire testing process/ system. 6For this purpose. the data is to be evaluated statistically to determine whether they are mutually consistent and if they meet the specifications used. 1WHO GLP hence recommends performing verification of the pharmacopoeial and externally validated procedures to assure suitability of performance under actual conditions of use. the uncertainty of measurements is to be reported. Regular trend analysis along with 6control chart can easily detect such results. For example in a tablet formulation an excipient may be such that it may hinder the quantitation of the main ingredient or reagent in use is as such that the result is negatively biased.tests may proof to be useful.In case of reporting results of investigative testing.tests. Other statistical tool like Grubbs' test can be applied for the purpose.In case of regular test results. Indian companies who are interested towards 1WHO GLP compliance in laboratories need to focus on these additional points: a)Statistical evaluation of test results:.3. wherever appropriate.It is an usual practice of not performing validation study on pharmacopoeial method. majority laboratories adopt them without performing 11specificity. precision or linearity studies. b)Investigation of atypical test results:. There are many ways to evaluate such uncertainty factor. Uncertainty associated with the data needs to be reported as a result which is a measure of dispersion/ precision of the data .Possibly this is aimed towards Out of trend (OOT) test results which may/ may not be within specification . Inclusion of new concepts for better lab quality assurance: WHO has introduced a series of new concepts for more reliable testing procedure and data reporting. reagents and other parameters available during testing may not provide the desired reliability of result. The equipments. t. In case of pharmacopoeial procedures. d)Verification of pharmacopoeia or validated analytical procedures:. c)Reporting uncertainty of results:. In other words.tests and f. accuracy. paired t. certificate of analysis of reagents & other chemicals. This is a logical approach which is also recommended by 9ISO 9001: 2008. etc. reasons and justification for changes. standard operating procedures .sufficient scientific justification for the parameters (stated under validation) not being checked. Requirement for premises: For the pharmaceutical manufacturers. training manual.As per 1WHO GLP. and many other. e)Verification of equipments:. There are few areas which needs to be attention:- a) Change rooms:. Documentation requirements: Both internal and externally generated records and documents are recommended to be controlled by 1WHO GLP. installations willing to comply to the national standards only may head towards problem in tracking the changes .As defined by 1WHO GLP “ verification of performance is the test procedure regularly applies to a system to demonstrate consistency of purpose” . as leads to traceability and a good audit trail of the work practices. this is possibly the most discussed topic after the advent of both Schedule L1 or 1WHO GLP. Schedule LI clearly lacks this scientific distinctness. specification manual. 1WHO GLP recommends a written verification programme for laboratory instruments. verification of balances using suitable test weights (internal calibration system). For example verification of pH meters with standard certified buffer solutions before use. 4. Moreover. etc. as this involves a good investment in constructions and installations. The steps of revision are clearly defined and a Master List identifying current version vis-à-vis distribution is recommended to be established. This is not mandatory according to Schedule L1. internally generated documents encompasses quality manual (if it is impendent unit). For a laboratory . whilst the externally generated documents meant here are calibration certificates. upon every revision or new inclusion of document. 5. audit and inspection reports. 1WHO GLP advices to train the staffs and to preserve their acknowledgment of training through signature. the rest and refreshment rooms are . As these are not mentioned in the 2Schedule L1 or in 3Schedule M. records and standards needs to be well documented as . reference substances. sampling. The feasibility of bio.) are to be appropriate to the functions and operations to be performed. microbial count or particle size monitoring can be skipped in lab areas where it may not be required. relative humidity including bio burden in both controlled and uncontrolled area. instrument handling . It also necessitates monitoring of temperature. testing is what is required. controlled and documented. Accountability(Liability): Wading through the WHO GLP guidelines.handling units with not-so. etc) of the laboratory processes leading to technical results and conclusions. equipments. T. simple air. changing areas and toilets to be easily accessible and appropriate for the number of users. No such mention is present in 2Schedule L1. WHO GLP seems more elaborate about the requirements of the storage facilities. reagents handling . In such areas. etc. b) Laboratory environment:. To put differently. It has recommended that the environmental conditions (lighting. As such the entire laboratory will have to be covered with air handling units cum an expensive 10Ffilter in order to block the CFUs and particles as per its own set limits and will have monitor for any aberrant trend.burden monitoring in uncontrolled area . Defined job responsibilities of not only the personnel involved in storage. standard preparation. As such. energy sources. preparations.filters) can serve the purpose of maintaining temperature and relative humidity only . Additionally the environmental conditions are to be monitored. There is no need of strictness regarding the limits of bio. Additionally.expensive coarse filters (10G. one would find mention of defining accountability for all important functions (sampling. WHO GLP is pretty relaxed in this aspect.burden or particle as such. but accessibilities to documents. There is no defined or mandatory requirement. P. except for areas for microbiological laboratory (which needs to be aseptic). RH. Schedule L1 mandates regular monitoring of particle size and microbial count in the entire laboratory area in addition to temperature and relative humidity .recommended to be separate from laboratory areas.There is mention of air ventilation system that ensures dust free environment in Schedule L1. particularly in areas of the laboratory where destructive tests are carried out indeed needs a second thought. for example in areas where analytical tests which are destructive in nature are (test material not returned to the main bulk) are carried out. 6. c)Space requirement:.Though both 1WHO GLP and Schedule L1 requires adequate space for storage of documents and records. retained samples. gases. accessibility to documents. etc. samples. Supplier’s evaluation A documented system of suppliers and service provider‟s evaluation and monitoring is a testimonial of quality assurance of laboratory. WHO GLP strongly recommends this. no-where there is indicated of a mandatory written down job description for each activities. This approach is lacking in Schedule L1. evaluation of critical consumables. one of the reasons for birth and subsequent evolution of GLP is to avoid masking of true data. if any. specifications. In order to achieve this. Drugs and Cosmetics Act. Even in case of subcontracting of testing. and scope for subsequent corrective action. This requirement is also not clearly stated in Schedule L1. 1940 have a common theme of assuring reflectance of the true value of the sample under test. both of . Analytical Worksheet As stated in the „Introduction‟ section. For the purpose. Reporting the identification number of the reference standard or material. Result WHO GLP and Schedule L1. This can be assured by maintaining a good trail of every data reported. Now think of a situation where the analyst tears the page of the worksheet where the original data is reported and does a fresh reporting with the revised data in a new page!! In such a case there wont be requirement of providing justification for change along with accountability. WHO GLP recommends that the analytical worksheets should have proper page numbering. Schedule L1 prescripts about erasing a data through a single line upon change along with reporting the reason for change.record and authorized. test methods along with the analyst and the supervisor involved in approval and checking surely allows a quick identification of error. which includes maintaining a list of approved suppliers. identification of the equipment used. periodic assessment is highly advised. supplies and services which affect quality of testing. vis-à-vis identification of the analyst making the change via his signature. Where lies the traceability then??? For this purpose. 8. A worksheet containing consecutively numbered pages unquestionably avoids situations as described above. This dictates about assigned duties in a laboratory and authorized personnel for carrying out activities in microbiological lab. including total number of pages (and including annexes). 7. Schedule L1 does not include this. r. Government of India.t staffing. the more is the expenditure w. and low downtime. In comparison to this international guideline. like ICH. but nothing is said about situations when during such checking. mutual recognization of results. like OOS investigations. etc are also provided. Government of India. 957. improved data quality.compliance is observed. . maintenance and monitoring of required parameters. References: 1. Recommendations made by WHO GLP is much distinct and highly structured.Drugs and Cosmetics Act.Schedule L1: Good Laboratory Practices. Ministry of Health. 8OMCL. it might not be possible to jump to the acumen level at one go. avoiding repetition of studies. documentation . distinct technical problems (at least the frequently encountered ones . it dictates a regular monitoring. 1945. In the context of small to medium scale Indian pharmaceutical laboratories (both contractual and manufacturers).Schedule M: Good manufacturing practices and requirements of premises. 2008. But as always the regulatory bodies suggest a good quality assurance programme ultimately leads to benefit in all ways. stricter the regulations .these have moved several steps forward w. a non. Government of India. Similarly. plant and equipment for pharmaceutical products.t the recommendations stated under respective “quality control” sections under respective Good Manufacturing Practices. In many aspects it is indistinct too. Discussion As known to all. adoption of modern approaches as discussed makes it scientifically sound. Continued improvement in the rule with adequate time for the laboratories to comply with the changing rules will definitely lead to achieving the purpose. Not only the requirements are clearly defined. Schedule L1 is brief. suitable references to other guidelines. Differences are present in the approach to achieve the motive. WHO Expert Committee on specifications for pharmaceutical preparations. 3. Drugs and Cosmetics (Third Amendment) Rules. regarding working standards. WHO Technical Report Series. 2. For example. Moreover.Annex 1: WHO good practices for pharmaceutical quality control laboratories . it has prescribed about investigation of technical complaints. Forty-fourth report. 4. reliability and reproducibility of data. changes etc) that may arise and their approach for redressal should have been clearly mentioned.r. International Conference on Harmonization. U. 1996:p. Food and Drug Administration. Current Good Manufacturing Practices.Moorthy CK. Good manufacturing practices and inspection. Introduction to Statistical Quality Control. A compendium of guidelines and related materials. 9. September 2006: p. John Wiley & Sons Publication.www.6sigma. 8. Geneva. 2nd updated edition. November 2005. Volume 2. 3rd ed. 508-599. Uncertainty of measurement. 7.77-119. 1st ed.htm. Center for Drug Evaluation and Research (CDER). World Health Organization: 72. Center for Biologics Evaluation and Research (CBER).ISO 9001: 2008: Quality Management System 10. Volume III.OMCL network of the Council of Europe . Quality Assurance Document.Montgomery Douglas C.S. Twitter or Mail .5.Guidance for Industry. Q2 (R1) Validation of Analytical Procedures: Methodology. December 2007. Department of Health and Human Services.us/handbook/eda/section3/eda35h. 6. 11.Quality assurance of pharmaceuticals. published by Center for GMP.. Email ThisBlogThis!Share to TwitterShare to Facebook Send these Article to Your Friends on Facebook. 127-132. 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