APIC: Update of the "Cleaning Validation" Guide for APIs

Recommendation

Tuesday, 28 May 2024 15.30 - 17.30 h

Ethylene and Diethylene Glycol Testing - LIve Webinar
Pharmacopoeial Activities, Regulatory Developments and Analytical Testing

The new version of the document "GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS" was finalised in February 2021 and is now available on the APIC website. It can be used as a supplement for implementing cleaning validation programmes for API manufacturing sites and highlights issues and topics that have already arisen or could arise in the context of cleaning validation. In this version, the responsible task force of APIC's Quality Working Group - a sector group of the European Chemical Industry Council (CEFIC) - has mainly made additions and updates to chapters (4) Acceptance Criteria and (9) Cleaning Validation Protocol.

Chapter 4

In chapter 4, particularly in section 4.2 Methods of Calculating Acceptance Criteria, individual paragraphs have been completely revised and new passages have been added. These include, for example, paragraphs 4.2.3 "Acceptance criteria for therapeutic macromolecules and peptides" and 4.2.1 "Acceptance criteria using health-based data" with subparagraphs 4.2.1.1, 4.2.1.2, and 4.2.1.3. Updates were also made to paragraph 4.2.4 "Swab limits."

Chapter 9

In addition to some formal changes, Section 9.8 Training has been added to this chapter. It specifies that personnel involved in the tasks of sampling, cleaning and testing of equipment must be trained accordingly.

Beside the new version of the "GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS", an updated version of the "How to do" document - Interpretation of ICH Q7 Guide and the "Review form" for APIs was also published by the APIC earlier this year. A summarised listing of the updated passages of this guidance can be found here.