The latest version (version 16) of the “How to do” document – Interpretation of ICH Q7 Guide and “Review form” for active pharmaceutical ingredients was finalised in July 2022 and published on the new website of the APIC (Active Pharmaceutical Ingredients Committee) at the end of October.
The document aims to facilitate the implementation of the ICH Q7 guideline and provides recommendations on how it can be interpreted.
In this new version, the responsible task force of the APIC Quality Group, has made formal changes, additions and updates in the chapters (1) Introduction, (6) Documentation and Records, (10) Storage and Distribution and (12) Validation.
Following are some examples of relevant changes:
Chapter 6 Documentation and Records
This chapter has been thoroughly revised and contains many adjustments and innovations as well as formal changes. For example, in the first paragraph 6.1 “Documentation System and Specification” the acronym ALCOA has been replaced by ALCOA+, and more attention has been paid to electronic documentation and hybrid documentation systems.
In section 6.14, the sub-heading “Electronic systems” has been added; in sections 6.15, 6.16 and 6.17 have been almost completely reworded.
The following paragraphs have also been updated and revised:
- 2 “Equipment Cleaning and Use Record”,
- 3 “Records of Raw Materials, Intermediates, API Labelling and Packaging Materials”,
- 4 “Master Production Instructions (Master Production and Control Records)”,
- 5 “Batch Production Records (Batch Production and Control Records)”,
- 6 “Laboratory Control Records”,
- 7 “Batch Production Record Review”.
Chapter 10 Storage and Distribution
This chapter in the current version contains, in addition to formal changes, an adjustment in the second paragraph of section 10.11. All other steps in this chapter are left unchanged.
Chapter 12 Validation
In addition to numerous formal adjustments, this chapter has been fundamentally updated and reformulated.
In the first paragraph 12.1 “Validation Policy”, section 12.11 “Critical Parameters/Attributes General considerations” has been expanded to include the term Critical Quality Attribute (CQA) and its meaning has been described in detail.
In the same way, in paragraph 12.3 “Qualification” the term engineering has been added and in paragraph 12.8 “Validation of Analytical Methods” the sentence “The level of the validation required for in-process controls should be evaluated depending on the influence on the final API quality.” has been added.