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Good Manufacturing Practice (GMP) 2day course

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The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions

Published in: Health & Medicine
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Good Manufacturing Practice (GMP) 2day course

  1. 1. Dr. Jo Havemann 23rd to 24th of October, 2017 Good Manufacturing Practice access2perspectives.com
  2. 2. Access 2 Perspectives 2017 Good Laboratory Practice (GLP) Questionable Practices & Consequences Good Manufacturing Practice (GMP) GMP Quality Management & Assessment Digital GMP Solutions Career Opportunities
  3. 3. Access 2 Perspectives 2017 Good Scientific Practice (GSP) Good Laboratory Practice (GLP) Good Clinical Practice (GCP) Good Pharmacovigilance Practice (GVP) Good Regulatory Practice (GRP) Good Manufacturing Practice (GMP) Good Automated Manufacturing Practice (GAMP) Good Distribution Practice (GDP) Good Transportation Practice (GTP) Good Agricultural Practice (GAP) GxP
  4. 4. Access 2 Perspectives 2017 Good Scientific Practice (GSP) 1) General principles 2) Cooperation and leadership responsibility within working groups 3) Guidance for junior scientists 4) Securing and storing primary data 5) Data protection 6) Scientific publications 7) Conflicts of interest between science and industry 8) Appointing ombudspersons 9) Whistleblower protection mpg.de/197494/rulesScientificPractice.pdf
  5. 5. Access 2 Perspectives 2017 Good Laboratory Practice (GLP) 1972 1978 1992 1980 ChemG 1987
  6. 6. Access 2 Perspectives 2017 GLP Principles … help scientists obtain results that are • reliable • repeatable • auditable • recognised
  7. 7. Access 2 Perspectives 2017 GLP Principles … define conditions under which studies are • planned • performed • recorded • archived • monitored
  8. 8. Access 2 Perspectives 2017 GLP Principles Five Basic Points 1) Resources: Personnel, Facilities & Equipment 2) Characterisation: Test Article / Test System 3) Rules: Protocols, Study Plans, Procedures 4) Results: Raw data, Final report, Archives 5) Quality Assurance: Audit, Training, Advice
  9. 9. Access 2 Perspectives 2017 GLP Principles 1) Organization and Personnel Responsibilities 2) Quality assurance program 3) Facilities 4) Equipment, Reagents and Materials 5) Test systems (Physical/Chemical, Biological) 6) Test & Reference items 7) Standard operating procedures 8) Performance of Study 9) Reporting of results 10) Archival - Storage of Records and Reports
  10. 10. Access 2 Perspectives 2017 Good Laboratory Practice (GLP) Klimisch Score 1 – reliable without restriction 2 – reliable with restriction 3 – not reliable 4 – not assignable BASF H.J. Klimisch, M. Andreae and U. Tillmann (1997): A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data, Regulatory Toxicology and Pharmacology Vol 25, pp 1–5, doi:10.1006/rtph.1996.1076, PMID 9056496.
  11. 11. Access 2 Perspectives 2017 Good Laboratory Practice (GLP) REACH Regulation Registration Evaluation Authorisation and Restriction of Chemicals 2006 echa.europa.eu
  12. 12. Access 2 Perspectives 2017 Good Laboratory Practice (GLP) 6. Abschnitt gesetze-im-internet.de/chemg
  13. 13. Access 2 Perspectives 2017 Good Laboratory Practice (GLP) What can go wrong? Why are they useful? contamination non-conformative human failure wrong/no documentation wrong/no archiving equipment application insufficient training missing quality control insufficient repetition quality assurance end-consumer safety error traceability reproducibility process optimisation safety for humans & environment reliability
  14. 14. Access 2 Perspectives 2017 Good Manufacturing Practice (GMP)
  15. 15. Access 2 Perspectives 2017 GMP History 1906 Pure Food and Drug Act
  16. 16. Access 2 Perspectives 2017 1906 1937 Pure Food and Drug Act Federal Food, Drug, and Cosmetic Act GMP History
  17. 17. Access 2 Perspectives 2017 1906 1937 1962 Pure Food and Drug Act Federal Food, Drug, and Cosmetic Act Kefauver Harris Drug Amendments "Drug Efficacy Amendment" GMP History Thalidomide (Contergan)
  18. 18. Access 2 Perspectives 2017 1906 1937 1962 1978 Pure Food and Drug Act Federal Food, Drug, and Cosmetic Act Kefauver Harris Drug Amendments AMG Thalidomide (Contergan) GMP History
  19. 19. Access 2 Perspectives 2017 W. Edwards Deming (1900-1993)1. Better design of products to improve service 2. Higher level of uniform product quality 3. Improvement of product testing in the workplace and in research centers 4. Greater sales through side [global] markets GMP History
  20. 20. Access 2 Perspectives 2017 GMP Principles 1. Manufacturing facilities must maintain a clean and hygienic manufacturing area. 2. Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption. 3. Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. 4. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that affect the quality of the drug are validated as necessary. 5. Instructions and procedures are written in clear and unambiguous language. (good documentation practices - GDocP) 6. Operators are trained to carry out and document procedures. 7. Cross contamination with unlabelled major allergens is prevented. 8. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented. 9. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. 10.The distribution of the food or drugs minimizes any risk to their quality. 11.A system is available for recalling any batch from sale or supply. 12.Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence. en.wikipedia.org/wiki/Good_manufacturing_practice
  21. 21. Access 2 Perspectives 2017 GMP Guidelines ec.europa.eu/health/documents/eudralex/vol-4_en • Food CGMPs • Dietary Supplement CGMPs • Drug CGMPs • Medical Device CGMPs • Biological Product CGMPs • Animal Feed and Drug CGMPs • Cosmetic CGMPs fda.gov
  22. 22. Access 2 Perspectives 2017 ich.org International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
  23. 23. Access 2 Perspectives 2017 A M W H V Arzneimittel- und Wirkstoffherstellungsverordnung gesetze-im-internet.de/amwhv/BJNR252310006.html
  24. 24. Access 2 Perspectives 2017 GMP Enforcement Medicines & Healthcare Products Regulatory Agency  U.S. Food and Drug Administration Title 21 CFR Zentralstelle der Länder für Gesundheitsschutz
 bei Arzneimitteln und Medizinprodukten Aufgabe der Länderbehörden zlg.de/arzneimittel/deutschland/laenderbehoerden.html
  25. 25. Access 2 Perspectives 2017 picscheme.org/en/picscheme GMP Enforcement
  26. 26. Access 2 Perspectives 2017 Good Automated Manufacturing Practice (GAMP) International Society for Pharmaceutical Engineering since 1994 not legally binding published 2008 www.ispe.org
  27. 27. Access 2 Perspectives 2017 compliancesolutions.com pharma-sys.com luxxdata.de mastercontrol.com gensuite.com qualio.com etq.com instantgmp.com alegerglobal.com gmp-verlag.de arcondis.com Digital GMP Tools & Services >> always check credibility and liability of service providers <<
  28. 28. Access 2 Perspectives 2017 Factors that might lead to misconduct & fraud profit orientation personal enrichment hierarchical pressure lack of resources competition

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