Contaminated LVPs and the Origins of Validation - Pharmaceutical Technology

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Contaminated LVPs and the Origins of Validation
Fundamental validation skills related to heating, ventilation, and air conditioning must be thoroughly understood. Knowing the early history and development of validation is essential to understand the current set of regulations and standards governing the industry. This article reviews the history and outcome of contamination in large-volume parenteral drug products and discusses the qualification requirements of modern HVAC systems.

Pharmaceutical Technology

3. FDA, "Human Drugs—Current Good Manufacturing Practice in Manufacture, Processing, Packing or Holding of Large Volume Parenterals, and Request for Comments Regarding Small Volume Parenterals," Fed. Regis. 40 (106), 22202–22208 (June 1, 1976).

4. "Epidemiological Notes and Reports: Septicemias Associated with Contaminated Intravenous Solutions—Wisconsin, Ohio," Morbidity and Mortality Weekly Report (Center for Disease Control, Atlanta, GA, Mar. 17, 1973) pp. 99.

5. FDA, Guideline On General Principles Of Process Validation (Food and Drug Administration, Rockville, MD, May 1987).

6. X. Mao, "Energy Saving Tips for Desiging Air Handling Units (AHUs) in Cleanrooms," Pharm. Eng. 26 (2), 1–5 (2006).

7. W. Garvey, "Essentials of Validation Project Management, Part 1," Pharma. Technol. 29 (12), 68–76 (2005).

8. W. Garvey, "Essentials of Validation Project Management: Part 2," Pharma. Technol. 30 (1), 72–86 (2006).

9. EC, Guide to Good Manufacturing Practice Revision to Annex 1, Manufacture of Sterile Medicinal Products (European Commission, Brussels, Belgium, May 2003).

10. ISO 14644-1: Cleanrooms and Associated Controlled Environments-Part:1 Classification of Air Cleanliness (International Organization for Standardization, Geneva, Switzerland, 1999).


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