Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

SPECIFIC DOCUMENTS


 

Documents of interest for cleaning validation.

1. Cleaning Memos Topic Index

2. FDA’s cleaning validation guideline a key resource for anyone involved in cleaning validation.

3. Annex 15 to EU GMPs covers cleaning validation among other items

4. FDA’s Q&A for CGMP  FDA’s replacement for “Human Drug CGMP Notes.”

5. PIC/S PI 006-3 The basis of Draft Annex 15.

6. Canadian Cleaning Validation Guidelines from Health Canada (also available in French).

7. 21CFR 210-211 (GMPs) the FDA’s GMP speak frequently about cleaning and sanitizing.

8. FDA Compliance Program Guidance Program Manual for “Drug Manufacturing Inspections” The new program for how FDA will do inspections. See the March 2001 Cleaning Memo for a discussion of how this might impact cleaning validation.

9. CBER Compliance Program 7345.848 CBER Quality System inspection program for biological drugs

10. FDA Process Validation: General Principles and Practices New (2011) FDA guideline. Not specific to cleaning validation, but helpful in its validation concepts.

11. ICH Quality Guidelines includes guidelines on analytical method validation and on validation of API manufacturing

12. Active Pharmaceutical Ingredients Committee (APIC) "Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredient Plants" (2014)

13. WHO cleaning validation guidance Appendix 3 of Annex 4 is the section on cleaning validation.

14. PIC/S PI 030-1 Aide-Memoire: Inspection of Active Pharmaceutical Ingredients.

15. Press Release FDA Takes First Step in Recognizing the Role of Emerging Technologies in the Area of Process Validation, March 2004

16. EMA/INS/GMP/809387/2009 EMEA Update on Revision of Chapters 3 and 5 of the GMP Guide: "Dedicated Facilities" (December 10, 2009)

17. EduraLex Volume 4, EU Guidelines for GMP, Draft Annex 2 Manufacture of Biological Medicinal Substances and Products for Human Use (April 9, 2010)

18. ANVISA Resolution - RDC no. 17, of April 16, 2010 Article 125 (page 20) deals with "segregation" for hormones, cytotoxics, and some antibiotics.

19. EMA's "Concept Paper on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities" (2011)

20. EMA "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" (November 20th, 2014)

21. EMA DRAFT Q&A on Limits for Shared Facilities (2016)

22. ICH Q7 Questions and Answers (2015)

23. Relevant Risk-MaPP Critique Documents

24. FDA "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance-Equipment" [Note: This Q&A has questions and answers related to cleaning validation, including use of TOC.]

25. FDA "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance-Buildings and Facilities" [Note: This Q&A has questions and answers related to penicillin.]

26. FDA "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance-Production and Process Controls." [Note: This Q&A has questions and answers related to objectionable organisms.]

27. FDA "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance-Laboratory Controls." [Note: This Q&A has questions and answers related to TOC and penicillin.]

28. FDA "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance-Control of Components and Drug Product Containers and Closures." [Note: This Q&A has questions and answers that are related to pathogenic agents and animal-derived drug ingredients.]