RISK MANAGEMENT AND ASSESSMENT
Quality risk management (QRM) involves elements of risk assessment, risk control, and periodic review to ensure continuous
and effective control (6). It is important to achieve a shared understanding of the application of risk management among diverse
stakeholders. Successful implementation of QRM requires support of the whole team, including operations, technical services,
engineering, quality control, quality assurance, and regulatory personnel. This support is essential to identifying and addressing
conditions that affect CPPs and CQAs for the cleaning or manufacturing process.
This article has reviewed the key issues in biotech cleaning validation. The authors encourage all biotech manufacturers to
consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
Anurag S. Rathore* is a biotechnology chemistry, manufacturing, and controls consultant and a faculty member at the Indian
Institute of Delhi, India, +91 9650770650, firstname.lastname@example.org
. Rathore is also a member of BioPharm International's editorial advisory board. Destin A. LeBlanc is the principal consultant at Cleaning Validation Technologies.
*To whom all correspondence should be addressed.
1. PDA, Technical Report No. 49: Points to Consider for Biotechnology Cleaning Validation (PDA, Bethesda, MD, July 2010).
2. PDA, Technical Report No. 29: Points to Consider for Cleaning Validation (PDA, Bethesda, MD, Nov. 1998).
3. PDA, Technical Monograph, Cleaning and Cleaning Validation: A Biotechnology Perspective (PDA, Bethesda, MD, Dec. 1995).
4. ICH, Q2 (R1) Validation of Analytical Procedures: Text and Methodology, Step 4 version (2005).
5. ICH, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Step 4 version (2000).
6. ICH, Q9 Quality Risk Management, Step 4 version (2005).