Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities

Reference

1. 1.↵
   Quality Risk Management, Q9, ICH Harmonised Tripartite Guideline, November 2005.
2. 2.↵
   Eudralex, Volume 4, Chapter 5.18.
3. 3.↵
   EU GMPs, Annex 2, Chapter 6(d).
4. 4.↵
   PDA Technical Report 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.
5. 5.↵
   PDA Technical Report 54-4, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, Annex 3: Case Studies in the Manufacturing in Biotechnological Bulk Drug Substances.
6. 6.↵
   PDA Technical Report 49, Page 14, Section 3.7.2 Introduction of New Soils to a Validated Cleaning System.
7. 7.↵
   1. Sharnez R.,
   2. Spencer A.,
   3. Romero J.,
   4. Runkle S.,
   5. Carolan C.,
   6. Hayes R.,
   7. Mott A.,
   8. Clark M. E.,
   9. Wyman E.,
   10. Rasmi M.,
   11. Donat S.,
   12. Bellorado K.

   Methodology for Assessing Product Inactivation during Cleaning Part I: Experimental Approach and Analytical Methods. J. Validation Technol. 2012, 18 (4), 42–45.

   OpenUrl
8. 8.↵
   1. Mott A.,
   2. Henry B.,
   3. Wyman E.,
   4. Bellorado K.,
   5. Blümel M.,
   6. Parks M.,
   7. Hayes R.,
   8. Runkle S.,
   9. Luo W.

   Methodology for Assessing Product Inactivation during Cleaning Part II: Setting Acceptance Limits of Biopharmaceutical Product Carryover for Equipment Cleaning. J. Validation Technol. 2013, 19 (4).
9. 9.↵
   International Conference on Harmonisation Regulations Q7, Chapter 12.76.
10. 10.↵
    Eudralex, Volume 4, Chapter 5.24.
11. 11.↵
    The Code of Federal Regulations, Title 21- Food and Drugs, Part 211.67 (6).
12. 12.↵
    Elastomer Change-Out – Justification for minimizing the removal of elastomers in order to prevent cross contamination in a multi product facility, Parks, Michael; O'Dwyer, Naimh; Bollinger, Jeremy; Johnson, Alan; Goss, Brian; Runkle, Scott; Wyman, Ned; Arroyo, Adema; Wood, Joseph.
13. 13.↵
    ISPE Baseline Pharmaceutical Engineering Guide Volume 6.
14. 14.↵
    ISPE Baseline Guide Biopharmaceutical Manufacturing Facilities.
15. 15.
    PDA Technical Report 49, Points to Consider for Biotechnology Cleaning Validation.
16. 16.↵
    PDA Technical Report 29, Points to Consider for Cleaning Validation.
17. 17.↵
    ISPE Baseline Guide for New and Renovated Facilities.