29/30 September 2021
The first edition of the "How to do Document - Interpretation of the ICH Q7 Guide" was published by APIC shortly after the ICH Q7 Guideline appeared as Step 4 document in November 2000. In the meantime it has undergone a numer of revisions and the current version of the How to do Document to be found on the publications section of APIC's website is an update from August 2015 (version 8). This document was written by experts from the European Industry (CEFIC APIC) and is essentially an interpretation of “how to” implement the requirements of the ICH Q7 Guide based on practical experience.
On the occasion of the publication of the ICH Q7 Questions & Answers Document in June 2015 another revision of APIC's How to do Document was necessary. APIC is currently working on this new revision (version 9) taking into account the new ICH Q7 Q&A Document which will be incorporated into the How to do Document as a new chapter 21. In this chapter each Question/Answer of the Q&A document is examined and commented with respect to its practical implementation. The following example illustrates what these practical comments look like:
ICH Q7 Q&A - Question
For dedicated equipment, is ‘visually clean’ acceptable for verification of cleaning effectiveness, (i.e., no expectation for specific analytical determination)?
ICH Q7 Q&A - Answer
‘Visually clean’ may be acceptable for dedicated equipment based on the ability to visually inspect and sufficient supporting data from cleaning studies (e.g., analytical determination to demonstrate cleaning effectiveness) [ICH Q7, Section 12.76]. Equipment should be cleaned at appropriate intervals (e.g., time or number of batches) to prevent build-up and carryover of contaminants (e.g., degradants or objectionable levels of microorganisms) so that they do not adversely alter the quality of the API [ICH Q7, Sections 5.23, 12.7].
Comment in APIC's How to do Document
"dedicated equipment" can be defined in various ways such as:
- a reactor that is used solely for 1 API process
- a reactor used for different intermediate steps of the same API.
- a reactor used for different steps in the same intermediate or API
- a reactor solely used for 1 stage in 1 process
Whatever definition is used it should be documented and justified.
When visual inspection is applied following points should be considered:
- adequate lighting
- fully dried
- difficult to clean spots visually inspectable
- use of cameras, endoscopy
- limit of detection of visual cleanliness
- dirty hold time / clean hold time
- Campaign length
While the purpose of the ICH Q7 Q&A Document is to clarify some equivocal issues of the ICH Q7 Guideline the comments of APIC's ICH Q7 Q&A How to do Document intend to give support on an even more practical level. So after its finalisation and publication later this year the API industry will have another very useful document available which facilitates the implementation of the ICH Q7 principles.
At the pre-Conference Session to the 19th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients on 22 November 2016 in Barcelona APIC will launch the ICH Q7 Q&A How to do Document as a stand alone document. All participants will receive a copy.