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

The latest version (version 15) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs was finalised and published on the APIC website in July 2021. It is also intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it.

The responsible Task Force of the Quality Group of APIC, which is a sector group of the European Chemical Industry Council (CEFIC), has mainly completed and updated chapters (7) Materials Management, (8) Production and In-Process Controls, (10) Storage and Distribution, (11) Laboratory Controls and (14) Rejection and Reuse of Materials as well as chapter (17) Agents, Brokers, Traders, Distributors, Repackers and Relabellers.

Chapter (7) "Materials Management" and (8) "Production and In-Process Controls

In Chapter (7), only the last section on highly toxic raw materials in paragraph 7.3 "Sampling and Testing of Materials" has been updated.

The latest version of chapter (8) "Production and In-Process Controls" contains, in addition to formal adjustments, changes primarily in sections 8.1 "Production Operations", 8.3 "In-process Sampling and Controls" and 8.5 "Contamination Control".
In paragraph 8.15, for example, the procedure for regularly occurring deviations has been included, and changes can also be found in paragraphs 8.10, 8.12 and 8.13.
In section 8.3, in particular, paragraphs 8.35 and 8.36 have been supplemented with the sentences "Cleaning status of the sampling tools should be identified." and "For these cases the level of investigation (in the lab,sampling, number of replicates) should be defined."
Section 8.5 also includes updates in two sections (8.51 and 8.52), citing the current ISPE Guideline information for APIs.

Chapter (10) "Storage and Distribution" and (11) "Laboratory Controls"

Chapter (10) "Storage and Distribution" now shows in the current version, besides formal changes, mainly adjustments in paragraphs 10.10, 10.11 and 10.20, which mostly contain rewordings and new formulations of the texts.

In chapter (11) "Laboratory Controls", the additional sentence "There should be SOPs (approved by the Quality Unit)..." has been inserted in paragraph 11.1 General Control in section 11.11 only.

Chapter (14) "Rejection and Reuse of Materials" and (17) "Agents, Brokers, Traders, Distributors, Repackers and Relabellers"

Chapter (14) "Rejection and Reuse of Materials" shows in the latest version besides formal adjustments some changes in the topics Reprocessing (14.2), Recovery of Materials and Solvents (14.4) and Returns (14.5). These updates take into account, for example, the topic of nitrosamine contamination.

In Chapter (17) "Agents, Brokers, Traders, Distributors, Repackers and Relabellers", only formal changes were made.

Earlier this year, you could read in our News about the previous version (version 14) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" which pointed out the updates and additions included in it.