Risk Management for Aseptic Processing - Pharmaceutical Technology

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Risk Management for Aseptic Processing
The author discusses the risks involved with aseptic processing, methods and tools used to identify and control risk, and regulatory guidelines relevant to the risk-management process.

Pharmaceutical Technology


Quality risk management is an essential tool for qualification of aseptic processes. It is not just a tool for CGMP compliance; it offers real benefits to the validation process by identifying risks and ensuring that critical risks are controlled. By focusing managing risks to the patient, pharmaceutical manufacturers can ensure that the right resources are applied at the right place at the right time—improving patient safety while eliminating unnecessary validation efforts.

Ed White is a QA validation specialist at Baxter Healthcare Corporation, 1700 Rancho Conejo Blvd., Thousand Oaks, CA, 805.375.6779,
. This article was first published in The Journal of Validation Technology, Vol. 15, Num. 2, Spring 2009.


1. FDA, Pharmaceutical CGMPs for the 21st Century—A Risk Based Appoach (Rockville, MD, Aug. 2002).

2. ICH Q9 Quality Risk Management, Nov. 9, 2005.

3. PDA, Technical Report No. 44, Quality Risk Management for Aseptic Processes, 2008 Supplement, Volume 62, No. S-1.

4. Oliver, James, J. of Valid. Technol., 14, (5), Autumn 2008.

5. WHO, Annex 7: Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals, WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-Seventh Report, Geneva, Switzerland, 2003.

6. FDA, Draft Guidance for Industry—Process Validation: General Principles and Practices (Rockville, MD, Nov. 2008).

7. European Commission, Enterprise Directorate—General, Working Party on Control of Medicines and Inspections, Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice: Qualification and Validation, Sept. 2001.


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