PDA Technical Report No. 29, Revised 2012 (TR 29) Points to Consider for Cleaning Validation (single user digital version)

Dec 2012
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It has been 14 years since PDA published the original Technical Report No. 29, and cleaning validation continues to play an important role in reducing the possibility of product contamination from pharmaceutical manufacturing equipment. Cleaning validation demonstrates that the cleaning process adequately and consistently removes product residues, process residues and environmental contaminants from the manufacturing equipment/system, so that this equipment/system can be safely used for the manufacture of specified subsequent products (which may be the same or a different product).

The 2012 revision of Technical Report 29 builds on the 1998 report and utilizes principles and specific wording from the 2010 PDA Technical Report No. 49, Points to Consider for Biotechnology Cleaning Validation. It presents updated information that is aligned with lifecycle approaches to validation and the International Conference on Harmonisation (ICH) guidelines Q8 (R2) - Pharamaceutical Development, Q9 - Quality Risk Management and Q10 - Pharmaceutical Quality System. Also, this report aims to assist readers who want to create or benchmark a cleaning validation program for their equipment and facilities.

Written by a Task Force composed of European and North American professionals from pharmaceutical manufacturers, cleaning chemical suppliers, and consulting companies, the report has undergone a global, technical peer review to ensure concepts, terminology, and practices presented are reflective of sound science and can be used globally.

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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. Qualification
  5. Residue and Limits
  6. Sampling
  7. Analytical Methods
  8. Maintenance of Validated State
  9. Documentation
  10. Special Considerations
  11. Regulatory and Guidance Documents
  12. References
  13. Suggested Readings
  • Figures and Tables Index