A Review on Good Manufacturing Practice (GMP) for Medicinal Products
Keywords:
Good Manufacturing Practice, GMP, Pharmaceutical Inspection, Food and Drug Administration
Abstract
Good manufacturing practices (GMP) is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP guidelines provide minimum requirements for pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
References
1. Lund, W.: Good manufacturing practices. The pharmaceutical codex: principle and practice of pharmaceutics. London, Edition 12, The Pharmaceutical Press, 1994, 362-397.
2. Nally J. and Kieffer R.G.: GMP compliance, productivity and quality, Interpharm, 1998, 465-466.
3. Nally J.D.: Good manufacturing practices for pharmaceuticals, Informa healthcare USA, Inc., ISBN 10:0-8593-3972-3 & ISBN13:, Edition 6, New York, 2007, 978-0-8493-3972- 1.
4. Schedule M. good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products, 25.03.2012, cdsco.nic.in/html/GMP/ScheduleM(GMP).pdf
5. Asean: Asean operational manual for implementation of GMP, Indonesian national GMP team Asean, 2000.
6. Chaloner-Larsson, G. Anderson, R. Filho, M.A.F.C. & Herrera, J.F.G.: Validation In: A WHO guide to good manufacturing practice (GMP) requirements, World Health Organization, Geneva, 1997.
7. Wikipedia: Good manufacturing practice from Wikipedia, the free encyclopedia, 25.03.2012, en.wikipedia.org/wiki/Good manufacturing practice, 2012.
8. WHOTRS: WHO expert committee on specifications for pharmaceutical preparations: thirty-second report. WHO technical report series: 823, ISBN 92 4140823 6, ISSN Geneva, 1992, 0512- 3054.
9. Eudralex: 2012, Eudralex-Volume 4 Good manufacturing practice (GMP) Guidelines, 23.03.2012, ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.
10. WHOTRS: Annex 3 WHO good manufacturing practices: main principles for pharmaceutical products, In; WHO expert committee on specifications for pharmaceutical preparations Forty-fifth report WHO Technical report series 961, PP. 94-147, ISBN 978 92 4 120961 8, ISSN, Geneva, 2011, 0512-3054.
11. Sharp J.: Wider aspects of GMP. Good manufacturing practice: philosophy and applications. Illinois, Interpharm Press, 1991, 71-79.
12. US FDA.: Guidance for industry, Quality systems approach to pharmaceutical current good manufacturing practice regulations, Food and drug administration, center for drug evaluation and research (CDER), Center for biologics evaluation and research (CBER), Center for veterinary medicine, office of regulatory affairs (ORA), Rockville, MD, 2004, fda.gov/cvm/guidance/published.html.
13. WHOTR: Annex 2 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms, In; WHO expert committee on specifications for pharmaceutical preparations Fortieth report WHO technical report series 937, Geneva, 2006, 45-84.
14. WHOTR: Annex 3 WHO Good manufacturing practices: water for pharmaceutical use, In; WHO expert committee on specifications for pharmaceutical preparations Thirty-ninth report WHO technical report series 929, 40-58, ISBN 92 4 120929 1, ISSN Geneva, 2005, 0512-3054.
15. Sharp, J.: Quality in the manufacture of medicines and other healthcare products, pharmaceutical press, ISBN London, 2000, 0-85369-431-1.
16. Signore, A. A. and Jacobs, T.: Good design practices for GMP pharmaceutical facilities, Taylor & Francis group, ISBN Boca Raton, 2005, 10: 0-8247-5463-8 & ISBN 13: 978-0-247- 5463-1.
17. 21CFR 211: 2011, PART 211; current good manufacturing practice for finished pharmaceuticals, title 21-food and drugs, chapter I-food and drug administration, Department of health and human services subchapter C-Drugs: General, [Code of federal regulations, title 21, Volume 4, Revised as of April 1, 2011], 21.03.2012,
accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRart=211& showFR=1.
18. Patel K.T. and Chotai N.P.: Documentation and records: Harmonized GMP requirements, Journal of young pharmacists 2011, 3:138-150.
19. Immel, B. K.: 2005, A brief history of the GMPs, Regulatory compliance newsletter, The MP labeling system, (25.03.2012).
20. Sharp, J.: Good Pharmaceutical manufacturing practice rationale and compliance, CRC Press, ISBN Washington, D.C., 2005, 0-8493-1994-3.
21. US FDA: Improving public health through human drugs, CDER 2001 Report to the nation, Food and drug administration, Center for drug evaluation and research, 2001.
22. Wikipedia: Three-phase electric power from Wikipedia, the free encyclopedia, 01.05.2012, en.wikipedia.org/wiki/Three phase electric power, 2012.
23. PIC/S Secretariat (Ed.): guide to good manufacturing practice for medicinal products, Pharmaceutical inspection convention/ pharmaceutical inspection co-operation scheme PE 009-2 1 July 2004, Geneva.
24. Huber, L. (2012). Validation of analytical methods and procedures, 25.03.2012, labcompliance.com/tutorial/methods/default.aspx.
2. Nally J. and Kieffer R.G.: GMP compliance, productivity and quality, Interpharm, 1998, 465-466.
3. Nally J.D.: Good manufacturing practices for pharmaceuticals, Informa healthcare USA, Inc., ISBN 10:0-8593-3972-3 & ISBN13:, Edition 6, New York, 2007, 978-0-8493-3972- 1.
4. Schedule M. good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products, 25.03.2012, cdsco.nic.in/html/GMP/ScheduleM(GMP).pdf
5. Asean: Asean operational manual for implementation of GMP, Indonesian national GMP team Asean, 2000.
6. Chaloner-Larsson, G. Anderson, R. Filho, M.A.F.C. & Herrera, J.F.G.: Validation In: A WHO guide to good manufacturing practice (GMP) requirements, World Health Organization, Geneva, 1997.
7. Wikipedia: Good manufacturing practice from Wikipedia, the free encyclopedia, 25.03.2012, en.wikipedia.org/wiki/Good manufacturing practice, 2012.
8. WHOTRS: WHO expert committee on specifications for pharmaceutical preparations: thirty-second report. WHO technical report series: 823, ISBN 92 4140823 6, ISSN Geneva, 1992, 0512- 3054.
9. Eudralex: 2012, Eudralex-Volume 4 Good manufacturing practice (GMP) Guidelines, 23.03.2012, ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.
10. WHOTRS: Annex 3 WHO good manufacturing practices: main principles for pharmaceutical products, In; WHO expert committee on specifications for pharmaceutical preparations Forty-fifth report WHO Technical report series 961, PP. 94-147, ISBN 978 92 4 120961 8, ISSN, Geneva, 2011, 0512-3054.
11. Sharp J.: Wider aspects of GMP. Good manufacturing practice: philosophy and applications. Illinois, Interpharm Press, 1991, 71-79.
12. US FDA.: Guidance for industry, Quality systems approach to pharmaceutical current good manufacturing practice regulations, Food and drug administration, center for drug evaluation and research (CDER), Center for biologics evaluation and research (CBER), Center for veterinary medicine, office of regulatory affairs (ORA), Rockville, MD, 2004, fda.gov/cvm/guidance/published.html.
13. WHOTR: Annex 2 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms, In; WHO expert committee on specifications for pharmaceutical preparations Fortieth report WHO technical report series 937, Geneva, 2006, 45-84.
14. WHOTR: Annex 3 WHO Good manufacturing practices: water for pharmaceutical use, In; WHO expert committee on specifications for pharmaceutical preparations Thirty-ninth report WHO technical report series 929, 40-58, ISBN 92 4 120929 1, ISSN Geneva, 2005, 0512-3054.
15. Sharp, J.: Quality in the manufacture of medicines and other healthcare products, pharmaceutical press, ISBN London, 2000, 0-85369-431-1.
16. Signore, A. A. and Jacobs, T.: Good design practices for GMP pharmaceutical facilities, Taylor & Francis group, ISBN Boca Raton, 2005, 10: 0-8247-5463-8 & ISBN 13: 978-0-247- 5463-1.
17. 21CFR 211: 2011, PART 211; current good manufacturing practice for finished pharmaceuticals, title 21-food and drugs, chapter I-food and drug administration, Department of health and human services subchapter C-Drugs: General, [Code of federal regulations, title 21, Volume 4, Revised as of April 1, 2011], 21.03.2012,
accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRart=211& showFR=1.
18. Patel K.T. and Chotai N.P.: Documentation and records: Harmonized GMP requirements, Journal of young pharmacists 2011, 3:138-150.
19. Immel, B. K.: 2005, A brief history of the GMPs, Regulatory compliance newsletter, The MP labeling system, (25.03.2012).
20. Sharp, J.: Good Pharmaceutical manufacturing practice rationale and compliance, CRC Press, ISBN Washington, D.C., 2005, 0-8493-1994-3.
21. US FDA: Improving public health through human drugs, CDER 2001 Report to the nation, Food and drug administration, Center for drug evaluation and research, 2001.
22. Wikipedia: Three-phase electric power from Wikipedia, the free encyclopedia, 01.05.2012, en.wikipedia.org/wiki/Three phase electric power, 2012.
23. PIC/S Secretariat (Ed.): guide to good manufacturing practice for medicinal products, Pharmaceutical inspection convention/ pharmaceutical inspection co-operation scheme PE 009-2 1 July 2004, Geneva.
24. Huber, L. (2012). Validation of analytical methods and procedures, 25.03.2012, labcompliance.com/tutorial/methods/default.aspx.
Published
2014-09-01
How to Cite
[1]
Chaudhari, V., Yadav, V., Verma, P. and Singh, A. 2014. A Review on Good Manufacturing Practice (GMP) for Medicinal Products. PharmaTutor. 2, 9 (Sep. 2014), 8-19.
Section
Articles
