“CURRENT GOOD LABORATORY PRACTICES” BY MUHAMMAD TANWEER ALAM (DIRECTOR) B.Pharm.,M.Pharm.,L.L.B.,M.D, M.R.S.H.(Eng),M.P.P.S, Ph.D, D.Sc.
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WHAT IS cGLP? “cGLP is concerned with the organizational PROCESSES and CONDITIONS with which the laboratory studies are PLANNED, PERFORMED, MONITORED, RECORDED AND MONITORED, RECORDED AND REPORTED” “cGLP TO ANALYSIS ASSURES THE QUALITY AND INTEGRITY OF DATA IN TAKING FINAL DECISION REGARDING QUALITY OF DRUG”.
Philosophy of G.L.P � TRUST AND CONSISTENCY � ESTABLISHMENT OF ANY SPECIFICATION, STANDARDS, SAMPLING PLAN, TEST PROCEDURE OR ANY OTHER PLAN, TEST PROCEDURE OR ANY OTHER LABORATORY CONTROL PROCEDURE INCLUDING ANY CHANGE. � FGA WORKING UNDER THE DRUGS ACT AND RULES FRAMED THERE UNDER WITH PHARMACOPOEIA AND (AWKM)
GOOD LABORATORY PRACTICES � BASIC REQUIREMENT OF G.L.P � HIGHLY QUALIFIED TECHNICAL COMPETENCE � WELL EQUIPPED � GOOD INTERNAL ORGANIZATION AND COORDINATION OF THE ACTIVITIES OF THE VARIOUS SECTION OF THE LABORATORY � COORDINATION WITH OTHER STAKE HOLDER
Current Good Laboratory Practices (c.G.L.P) COMPETENCE OF ALL ANALYST: � Knowledge of basic chemical principles, theories and laboratory techniques as gained in the courses of pharmacy, chemistry or other allied sciences. � Handling of common instruments like balances, U.V, pH meter, FTIR, HPLC, G.C, A.A, Dissolution, U.V, pH meter, FTIR, HPLC, G.C, A.A, Dissolution, D.T apparatus etc, required in compendial procedures. � Adequate knowledge of cGLP � To establish laboratory safety procedures � Communication of laboratory results in written reports with in stipulated times under Drug Act and rules
Grading of analysts This primarily based on skills or competence of an analyst
GRADE:1 � Knowledge of basic chemical principles, theories and laboratory techniques � Use of common equipments such as balances, pH � Use of common equipments such as balances, pH meter, Melting Point Apparatus, Refract meter, Autoclave, Polar meter, Moisture Analyzer, required to use according to procedures � Adherence to laboratory safety procedures � Application of required testing procedures � Communication of results in writing � Can analyze raw materials and finished products under guidelines of their supervisors
Grading of Analysts GRADE:2 In addition to that of grade one, the analyst should have attained: � Knowledge of the use of the more advance equipment, such as computerized HPLC/GC/IR, equipment, such as computerized HPLC/GC/IR, automated dissolution apparatus. � Knowledge of cGLP � Can independently analyze samples using established and validated analytical procedures
Grading of analysts GRADE: 3 In addition to that of grade 2 the analyst should have: � Knowledge of regulatory policies and requirements � Experience in analysis of samples, using compendial or monographic procedures � Knowledge of validation techniques and criteria for method acceptance acceptance � Can select and apply the appropriate analytical method � Can develop new methods or revise existing methods after validation � Participate in collaborative studies at inter or intra laboratory level � Can supervise the proficiency of analyst
Grading of analysts GRADE: 4 In addition to that of grade 1to 3 analyst should have: � Knowledge of the use of advanced instruments such as FTNIR, A.A, NMR, TOC etc. � Isolation, Purification and identification of Microorganism & Toxicological studies on animal etc � Planning of work for more efficient use of resources by using Two Channel and Four Channel Recorder for intact organs. � Knowledge of statistical methods for data evaluation � Leadership of a large group of analyst � Can make a stability plan and perform the testing accordingly � Able to standardize the reference standards
Grading of analysts GRADE: 5 In addition to all qualities, including highest experience of Drugs Control Administration � Good administrative qualities � Good knowledge of Drugs Act and Rules � Can conducts the collaboration studies including Audit & Inspections � Can evaluates new laboratory methods and S.O.Ps. � Can evaluate and review test reports. � Expertise in troubleshooting � Acts as a team leader. Principally Men, Machine, Material Analyst.
Desirable Qualities Of An Analyst 1. Possesses aptitude and attitude of mind become a competent analyst 2. Enjoy his assignment with pride 3. Punctual and disciplined 4. Has pleasant personality 5. Well organized and methodological 6. Has initiative, drive, creative, and urge and ability to interact 7. Flexible and appreciates other’s view point 8. Imbibes confidence in his colleagues 9. Ability to work independently and as a member of team 10.Plans his work for efficient use of time and resources 11.Can complete his assignment (practical and written) in a give time frame
Desirable Qualities Of An Analyst 12. Pays full attention to details (theoretical and practical) 13. Can identify the cause of and solve the problems 14. Able to think and evaluate scientifically and critically 15. Question what he is doing and why? 16. Always more than willing to improve quality of his work 16. Always more than willing to improve quality of his work 17. Possesses the experimental skills 18. Has sound knowledge of basic chemical principles, physical aspects and sound knowledge of Microbiology & Pharmacology 19. Able to follow oral and written instructions 20. Sound knowledge of cGLP 21. Knowledge of method validation techniques as a criteria for method and test reports acceptance
Desirable Qualities Of An Analyst 22. Sound knowledge of common compendial procedures 23. Knowledge of operations, calibration, and maintenance of common analytical instruments maintenance of common analytical instruments 24. Adherence to established laboratory safety procedures while performing his analytical functions 25. Good presentation and communication skills
Role of Government Analyst • Testing of Raw material & suspected drugs • To manage the sample integrity program • Handling of Results Out of specification • Instruments calibration • Analyst training program • Analyst training program • Method development program • Writing of procedures and product specification • Writing of SOPs and calibration procedures • Overall monthly and quarterly review certification / accreditation programs • Final issuance of test report.
Role of Director � Overall responsibility of admin and control of organization � Overall in process inspections for cGLP. � Approval of MOT & SOP other than pharmacopoeia (if any) � Determination of products defects (if any) � Handling of complaints and technical discussions with T.As/ A.Cs/ADCs/DDCs/D.C/D.G/Secretary/Minister Level. � Internal GLP Audit � Internal fortnightly PERs and Annual PERs of Staff and Officers working. � Overall Laboratory control and to give Direction on daily basis � Direct reporting to Drug Controllers, Director General Health, Secretary & other authorities.
REGULATORY CONTROL OF MARKETED DRUGS Sample Statistics JAN 2008 – Dec 2010 4000 3500 3000 2500 2000 1500 1000 500 0 Received Analyzed Standard Substandard Spurious 2008 2521 2850 2254 146 42 2009 3522 3725 3358 116 40 2010 3647 3483 3035 140 54
FUTURE PLAN OF MY INSTITUTION Long term Plan for strengthening of Central Drugs 1. Laboratory, Government of Pakistan, Karachi. 2. Research and Development in support with Central Research Fund from Ministry of Health, Islamabad. 3. Complete test/analysis of all API (Active Pharm. Ingredient) 4. Quality control of Phytomedicines and other 4. Quality control of Phytomedicines and other alternative medicines which are commonly marketed in Pakistan. Establishment of Pharmacological and Toxicological 5. testing. 6. Further accreditation and certification of CDL by world renown authorities 7. Further to strengthen the Human Resource with good governance.
������ ������ ������ ������ ������ ������ ������ ������ TO FACULTY OF PHARMACY REPRESENTATIVE OF INDUSTRY, EMINENT SCIENTIST & MY COLLEAGUES 13-01-2011
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