Applying Quality by Design to Sterile Manufacturing Processes - Pharmaceutical Technology

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Applying Quality by Design to Sterile Manufacturing Processes
The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.

Pharmaceutical Technology

In conclusion, the 2008 Draft Guidance for Industry on Process Validation: General Principles and Practices brings the product life-cycle approach to process development. The document provides insight into the "how" with regard to holding discussions on project management, documentation, verification, reviews, and methods (e.g., QbD, DOE, risk assessment) and reviews expectations from development to commercial processes for testing, validation, verification, and release. It is important that all pharmaceutical companies review the draft guidance and understand how it may affect their sterile manufacturing processes. The impact on confidentiality may be industry's biggest concern because process design and associated technical knowledge are what define a company's success.

Warren Charlton is a consultant at WHC Bio Pharma Technical Services, PO Box 20309, Greenville, NC 27858, tel. 252.327.4733, fax 252.756.4733,


1. ICH, Q8(R1) Pharmaceutical Development (Geneva, Switzerland, Nov. 10, 2005; Rev. 2008).

2. ICH, Q9 Quality Risk Management (Geneva, Switzerland, Nov. 9. 2005).

3. J. Agalloco et al., "FDA's Guidance for Industry: Process Validation: General Principles and Practices," presented at PDA, Jan. 14, 2009.

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 FDA, Draft Guidance for Industry—Process Validation: General Principles and Practices (Rockville, MD, Nov. 2008).

5. W. Charlton, T. Ingallinera, and D. Shive, "Validation of Clinical Manufacturing," and Validation Chapter, in Validation of Pharmaceutical Process, J. Agalloco and F. Carleton, eds. (Informa Healthcare, New York, 3rd ed., 2008), pp. 542–544.

6. Bausch & Stroebel Risk Analysis System.


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