Preparing Documentation to Support Clinical Supply Manufacture - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

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).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: Pharmaceutical Technology,
Click here