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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