Quality Agreements Between Pharmaceutical/Biopharmaceutical Companies and Their Contractors - - BioPharm International

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Quality Agreements Between Pharmaceutical/Biopharmaceutical Companies and Their Contractors


BioPharm International


REFERENCES 1. European Commission Directive 2003/94/EC of 8 October 2003.

2. European Commission Directive 91/412/EEC of 23 July 1991.

3. European Union Guide to Good Manufacturing Practice (EudraLex Vol. 4):

  • Chapter 7. Contract Manufacture and Analysis.
  • Proposed Addition to Chapter 1, as 1.5. Product Quality Review: 2 - DRAFT.
  • Annex 13, Revision 1. Manufacture of Investigational Medicinal Products: 4.
  • Proposed Addition (Annex 19). Reference Samples and Retention Samples.

4. FDA Warning Letter. Automatic Liquid Packaging, Inc.; September 23, 2002.

RESOURCES 1. Code of Federal Regulations, Title 21, Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.

2. Cohen, J.S. GMP: Current Compliance Issues for Biologics. Seventh Annual FDA-OCRA Educational Conference; June 2-3, 2004; Irvine, CA.

3. Early Drafting Of Separate Quality Agreements With Contractors Urged. The Gold Sheet. November 2002;Vol. 36, No. 11:1-13.

4. Finkbohner, J. Risk-Based Quality for Emerging Biotech Processes and Products. Ninth Annual GMP By The Sea: Keeping the "C" in GMP; August 25, 2004; Cambridge, MA.

5. International Conference on Harmonization. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Q7A, Chapter 16: Contract Manufacturers (Including Laboratories).

6. Using Risk To Determine Degree Of Supplier Control. The Silver Sheet. September 2004;Vol. 8, No. 9:6.


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