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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