Technical Report No. 49 (TR 49): Points to Consider for Biotechnology Cleaning Validation

Jul 2010
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Written by an authoring task force comprised of European and North American experts from biotechnology manufacturers, cleaning chemical suppliers, regulatory agencies and consulting companies, PDA Technical Report No. 49, Points to Consider for Biotechnology Cleaning Validation aligns cleaning validation practices with the life cycle approaches to validation, as enabled by the International Conference on Harmonisation guidelines on pharmaceutical development (Q8), quality risk management (Q9) and quality systems (Q10).

Cleaning validation plays an important role in reducing the possibility of product contamination from biopharmaceutical manufacturing equipment. It demonstrates that the cleaning process adequately and consistently removes product residues, process residues and environmental contaminants from the cleaned equipment/system, so that this equipment/system can be safely used for the manufacture of defined subsequent products (which may be the same or a different product). While cleaning validation for biotechnology manufacturing has many of the same elements as for other pharmaceutical manufacturing, there are enough differences such that a separate Technical Report focusing on biotechnology cleaning validation is appropriate.

TR-49 updates previous PDA documents on cleaning validation, including the 1998 PDA Technical Report No. 29, Points to Consider for Cleaning Validation and the 1996 monograph Cleaning and Cleaning Validation: A Biotechnology Perspective provide valuable insights for biotechnology manufacturers.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Cleaning Process Design and Development
  4. Acceptance Limits
  5. Sampling Methods
  6. Analytical Methods
  7. Cleaning Validation Protocols
  8. Maintenance of Validated State
  9. Master Planning for Cleaning Validation
  10. Risk Assessment and Management
  11. Special Considerations
  12. Regulatory Issues
  13. References
  14. Suggested Readings
  15. Appendices — Carryover Calculations
  16. List of Acronyms