Specific Documents

Documents of interest for cleaning validation.

• FDA’s cleaning validation guideline
  a key resource for anyone involved in cleaning validation.
• Annex 15 to EU GMPs
  covers cleaning validation among other items.
• FDA’s Q&A for CGMP
  FDA’s replacement for “Human Drug CGMP Notes.”
• PIC/S PI 006-3
  The basis of Draft Annex 15.
• Canadian cleaning validation guidelines
  from Health Canada (also available in French).
• 21CFR 210-211 (GMPs)
  the FDA’s GMP speak frequently about cleaning and sanitizing.
• 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.
• CBER Compliance Program 7345.848
  CBER Quality System inspection program for biological drugs
• FDA Process Validation: General Principles and Practices
  New (2011) FDA guideline. Not specific to cleaning validation, but helpful in its validation concepts.
• ICH Quality Guidelines
  includes guidelines on analytical method validation and on validation of API manufacturing.
• Active Pharmaceutical Ingredients Committee (APIC) documents
  includes both a policy and a guidance on cleaning validation in API facilities.
• WHO cleaning validation guidance
  Appendix 3 of Annex 4 is the section on cleaning validation.
• PIC/S PI 030-1
  Aide-Memoire: Inspection of Active Pharmaceutical Ingredients.
• Press Release
  FDA Takes First Step in Recognizing the Role of Emerging Technologies in the Area of Process Validation, March 2004
• EMA/INS/GMP/809387/2009
   EMEA Update on Revision of Chapters 3 and 5 of the GMP Guide: "Dedicated Facilities" (December 10, 2009)
• EudraLex Volume 4, EU Guidelines for GMP, Draft Annex 2
   Manufacture of Biological Medicinal Substances and Products for Human Use (April 9, 2010)
• ANVISA Resolution – RDC no. 17, of April 16, 2010 Article 125 (page 20) deals with “segregation” for hormones, cytotoxics, and some antibiotics.
• 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”