Preparing Documentation to Support Clinical Supply Manufacture - Pharmaceutical Technology

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Preparing Documentation to Support Clinical Supply Manufacture
This article is written to assist clinical manufacturing representatives at pharmaceutical companies who are faced for the first time with outsourcing the manufacture of clinical supplies. The author describes the identification, writing, and execution of documents required to support the contract manufacture of products for clinical studies.


Pharmaceutical Technology


5. P.A. Josephs and M.A. Iacobucci, "Selecting a Contract Manufacturing Provider," Pharm. Technol., Contract Services (supplement), 72–80 (1999).

6. W. Lowry Caudill, "Making Outsourcing a Success: A View from Both Sides," Pharm.Technol., Contract Services (supplement), 20–26 (1999).

7. D. Feuerhelm and G.S. Blank, "Documentation: It's Not Just Paper Work," BioPharm International 14 (8), 18–21, 64 (2001).

8. V. Hedgecock, "Preparing for Preapproval Inspections at Contract Manufacturers," Amer. Pharm. Outsourcing 3 (6), 23–34 (Nov. 2002).

9. R.P. Blasini, "Quality Agreements between Pharmaceutical and Biopharmaceutical Companies and Their Contractors," BioPharm International 18 (4), 66–74 (2005).

10. D. Rosenkrantz, "Quality Considerations for Managing Contract Service Providers," Amer. Pharm. Outsourcing 3 (3), 20–24 (2002).

11. International Organization for Standardization, ISO 2859-1:1999: Sampling Procedures for Inspection by Attributes, Part I: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection (ISO, Geneva, Switzerland, 1995).


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