References
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 4–6, 2011 and Brussels, Belgium, Nov. 14–16, 2011.
3. PQRI–FDA Workshop on Process Drift: Detection, Measurement, and Control in the Manufacture of Pharmaceuticals (Bethesda, MD, Dec.
1–3, 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 Laboratories–Voluntary Shutdown;" FDA Recalls, Updated Jan. 12, 2012.
6. FDA, Subject Drug Information Update–FDA, 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. 331–337): Prohibited Acts and Penalties Sections 301-307.
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