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

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 is further intended 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, which is a sector group of the European Chemical Industry Council (CEFIC), has made formal changes as well as additions and updates in the chapters (1) Introduction, (6) Documentation and Records, (10) Storage and Distribution and (12) Validation.

Chapter 1 Introduction

In Chapter (1), only the first paragraph of the sub-heading "Purpose of the Document", which is part of paragraph 1.1 "Objectives", has been amended with regard to the guidelines considered during the preparation of the new "How to Do" document.

Chapter 6 Documentation and Records

The chapter (6) "Documentation and Records" has been fundamentally revised and contains many adjustments and innovations in addition to formal changes. For example, in the first paragraph 6.1 "Documentation System and Specification" the abbreviation ALCOA has now been replaced by ALCOA+, and more attention has been paid to electronic documentation and hybrid documentation systems.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 and sections 6.15, 6.16 and 6.17 have been almost completely reworded. The following paragraphs have also been updated and revised

• 6.2 "Equipment Cleaning and Use Record",
• 6.3 "Records of Raw Materials, Intermediates, API Labelling and Packaging Materials", 
• 6.4 "Master Production Instructions (Master Production and Control Records)", 
• 6.5 "Batch Production Records (Batch Production and Control Records)", 
• 6.6 "Laboratory Control Records" and 
• 6.7 "Batch Production Record Review".

Chapter 10 Storage and Distribution

Chapter (10) "Storage and Distribution" now shows in the current version, apart from formal changes, an adjustment in the second paragraph of section 10.11. All other passages of this chapter remain in their previous version.

Chapter 12 Validation

In addition to many formal adjustments, this chapter has been fundamentally updated and reworded. In the first paragraph 12.1 "Validation Policy", section 12.11 "Critical Parameters/Attributes General considerations" was expanded to include the term Critical Quality Attribute (CQA) and its meaning was described in detail. Likewise, in paragraph 12.3 "Qualification" the term "engineering" was 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." was added.

In December last year, you could already read about the previous version (version 15) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form", including the updates and additions contained therein.