APIC: Annual Update of the ICH Q7 "How to do" Document

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 latest version (version 14) of the "How to do" Document - Interpretation of ICH Q7 Guide and "Review form" for APIs has been available on the APIC website since the beginning of the year. It is intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

In this version, the responsible Task Force of the Quality Group of APIC, which is a sector group of the European Chemical Industry Council (CEFIC), has mainly made additions and updates in chapters 11 -  Laboratory Controls, 15 - Complaints and Recalls, and in section 16 - Contract Manufacturers (incl. Laboratories). In the previous version 13, chapters 4 - Buildings and Facilities, 17 - Agents, Brokers, Traders, Distributors, Repackers and Relabellers, and 19 - APIs for use in Clinical Trials were revised and updated.

Chapter 11 "Laboratory Controls"

Chapter 11 "Laboratory Controls" was last updated in 2015. In addition to formal adjustments, the latest version contains changes in sections 11.10 General Control, 11.4 Certificates of Analysis, 11.5 Stability Monitoring of APIs, 11.6 Expiry and Retest Dating and 11.7 Reserve/Retention Samples. In paragraph 11.11, among other things, a new addition entitled "Approval/rejection of materials" has been included. Further, there are also changes in paragraph 11.19, which describes the handling of standards.

Chapter 15 "Complaints and Recalls"

Chapter 15 "Complaints and Recalls" was also last updated in 2015. Now the chapter shows formal changes, but mainly adjustments in sections 15.12 Complaints and 15.13 -15.15 Recalls.

Chapter 16 "Contract Manufacturers (incl. Laboratories)"

Chapter 16 "Contract Manufacturers (incl. Laboratories)" was last revised in January 2017. There are also formal adjustments in this chapter. In addition, some paragraphs were almost completely replaced by new texts. These include paragraphs 16.11 Supplier qualification, 16.12 Quality agreements and 16.13 Audits. In sections 16.5 and 16.16, there are now both additions as well as revisions.

In the "Publications" section of the APIC website, you will find the recently published "How to do" Document - Interpretation of ICH Q7 Guide and "Review form" as well as all guidance and recommendations published from 2020 and 2019. This includes, for example, the "APIC Guidance on Nitrosamines Risk Assessment".