Article

Cleaning Validation Proposed Standard | IVT

The following proposed standard is intended to reflect desirable contemporary practices, is not binding in any way, and can be modified to suit a firm's specific needs. This proposed standard incorporates imperative verbs (e.g., shall, will, must) to provide users with unambiguous quality assurance auditing tools, and is prefaced by a Preamble that provides rationale for several of the more complex concepts. This document is also directed toward users located at a given plant site that mayor may not be a part of a larger corporation. Terms that are bold and asterisked (*) the first time they are used are defined in Section IV - Glossary.

Contents of the Proposed Cleaning Validation Standard

In order to be consistent with the prototype standard (Validation Standard VS-l) the Proposed Cleaning Validation Standard VS-3 will be divided into the following five sections:

  1. Policy statements - Proposed standards that indicate what is required
  2. Procedural Statements - Proposed standards that describe how to meet requirements
  3. Acronyms - Meaning of each acronym/abbreviation used in the document
  4. Glossary - Definition of key terms, which are highlighted and asterisked (*) when first used in the proposed validation standard
  5. Regulatory Excerpts - Regulatory language (United States, Australia, Canada, World Health Organization [WHO], Japan, and European Union) related to each Standard

Download the Cleaning Validation Proposed Standard




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.

Comments (0)

Post new comment

The content of this field is kept private and will not be shown publicly.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
  • Use to create page breaks.
Image CAPTCHA
Enter the characters shown in the image.