Destin A. LeBlanc

Cleaning Validation Technologies

Technical Consulting Services

DOCUMENTS

Documents of interest for cleaning validation

 

  1. FDA’s cleaning validation guideline

a key resource for anyone involved in cleaning validation 

  1. Annex 15 to EU GMPs

covers cleaning validation 
among other items
  1. FDA’s Q&A for CGMP
 FDA’s replacement for “Human Drug CGMP Notes”

  1. PIC/S PI 006-3

The basis of Draft Annex 15.

  1. Canadian cleaning validation guidelines

from Health Canada (also available in French)

  1. 21CFR 210-211 (GMPs)

the FDA’s GMP speak frequently about cleaning and sanitizing
  1. 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.
  1. CBER Compliance Program 7345.848
 CBER Quality System inspection program for biological drugs

  1. FDA’s general validation guideline

old, but still a resource on 
general principles of validation

  1. ICH Quality Guidelines

includes guidelines on analytical method validation and on validation of API manufacturing
  1. Active Pharmaceutical Ingredients Committee (APIC) documents
 includes both a policy and a guidance on cleaning validation in API facilities
  1. WHO cleaning validation guidance
 Annex 3 is the section on cleaning validation

Destin A. LeBlanc

Cleaning Validation Technologies

1128 Eagle View Drive

Kodak, TN  37764

Phone:  865-932-6927

Fax:  865-932-6849

click here to contact Destin by email

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This page updated:  03/07/08 11:33 AM

Web updated: 7?11?2005

 

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