Costs of Failure in Product Quality - Pharmaceutical Technology

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Costs of Failure in Product Quality
The authors detail the possible consequences of noncompliance and a lack of quality control.

Pharmaceutical Technology
Volume 36, Issue 4, pp. 110-118


1. "Drug Makers Catch FDA's Drift, Look to Reduce Variability," The Gold Sheet, 45, (1), 2011.

2. Jeffrey Macher, "A Practical Approach to Effective Lifestyle Implementation of Systems and Processes for Pharmaceutical Manufacturing," Business Case for Quality, Pharmaceutical Quality Systems (ICH Q10) Conference, Arlington, VA, Oct 46, 2011 and Brussels, Belgium, Nov. 1416, 2011.

3. PQRIFDA Workshop on Process Drift: Detection, Measurement, and Control in the Manufacture of Pharmaceuticals (Bethesda, MD, Dec. 13, 2010.

4. Margaret M. Szymczak et al., Pharm. Tech., 35 (10) 70-74 2011.

5. FDA, The Small Biz Buzz, CDER Small Business Update Thursday December 22, 2011; "Ben Venue LaboratoriesVoluntary Shutdown;" FDA Recalls, Updated Jan. 12, 2012.

6. FDA, Subject Drug Information UpdateFDA, Justice Department Take Action Against McNeil-PPC Inc., Mar. 10, 2011.

7. Expert Briefings, Dec. 22, 2011.

8. FDA, Press Release, "Department of Justice Files Consent Decree of Permanent Injunction Against Ranbaxy," Jan. 25, 2012.

9. Novartis Consumer Health Press Release, Jan. 12, 2012, issues voluntary Nationwide Recall of Certain Over-the-Counter Products.

10. Citations, Federal Food Drug and Cosmetic Act (21 U.S.C. 331337): Prohibited Acts and Penalties Sections 301-307.


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