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

1. Dr. Jo Havemann
23rd to 24th of October, 2017
Good Manufacturing Practice
access2perspectives.com

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. 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. 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. Access 2 Perspectives 2017
Good Laboratory Practice (GLP)
1972
1978
1992
1980 ChemG
1987

6. Access 2 Perspectives 2017
GLP Principles
… help scientists obtain results that are
• reliable
• repeatable
• auditable
• recognised

7. Access 2 Perspectives 2017
GLP Principles
… define conditions under which studies are
• planned
• performed
• recorded
• archived
• monitored

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. 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. 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. Access 2 Perspectives 2017
Good Laboratory Practice (GLP)
REACH Regulation
Registration
Evaluation
Authorisation and
Restriction of Chemicals
2006
echa.europa.eu

12. Access 2 Perspectives 2017
Good Laboratory Practice (GLP)
6. Abschnitt
gesetze-im-internet.de/chemg

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. Access 2 Perspectives 2017
Good Manufacturing Practice
(GMP)

15. Access 2 Perspectives 2017
GMP History
1906 Pure Food and Drug Act

16. Access 2 Perspectives 2017
1906
1937
Pure Food and Drug Act
Federal Food, Drug, and Cosmetic Act
GMP History

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. 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. 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. 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. 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. Access 2 Perspectives 2017
ich.org
International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use

23. Access 2 Perspectives 2017
A M W H V
Arzneimittel- und
Wirkstoffherstellungsverordnung
gesetze-im-internet.de/amwhv/BJNR252310006.html

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. Access 2 Perspectives 2017
picscheme.org/en/picscheme
GMP Enforcement

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. 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. Access 2 Perspectives 2017
Factors that might lead to misconduct & fraud
profit orientation
personal enrichment
hierarchical pressure
lack of resources
competition