APIC updates its Guidance on Cleaning Validation with regard to the PDE Concept

Recommendation

15/16 February 2024

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In our news dated 11 June 2014 entitled "APIC publishes Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants", we already reported about the APIC "Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Now, a revision has brought the APIC guidance in line with EMA's guideline on "Shared Facilities".  

The original 55-page document is still divided into 13 chapters:

• Foreword
• Objective
• Scope
• Acceptance criteria
• Levels of Cleaning
• Control of Cleaning Process
• Bracketing and Worst Case Rating
• Determination of the Amount or Residue
• Cleaning Validation Protocol
• Validation Questions
• References
• Glossary
• Copyright and Disclaimer

The main changes were made to Chapter 4 on Acceptance Criteria so that the guideline is now 57 pages long. The document frequently uses the term PDE beside the criterion ADE so far mentioned. Both terms ADE/PDE i.e. ADE or PDE can be found. Whereby, it is stated in the document that the guidance preferably refers to ADE in the calculations examples as it enables a better comparison to the examples listed in the ISPE document Risk MaPP. A new element in Chapter 4 is the calculation formula for PDE with explanation of the respective abbreviations. The glossary has been updated accordingly. Moreover, editorial changes have been made to the document.

Conclusion: The revision of the APIC "Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants" in its current version from September 2016 has now introduced the PDE concept consequently. The content changes are only marginal though, as the PDE concept supplements only the previous ADE concept.

You can find the revised document on the APIC-Website.  In addition a comparison of the May 2014 Version with the September 2016 Revision is available in the Members' Area on the ECA Website.