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

ADVERTISEMENT

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.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines
Source: BioPharm International,
Click here