GMP Compliance Adviser Update No. 6/2017
With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
|8.A||Official requirements and agency expectations|
|C.5||EU GMP Guide Part II:
Basic Requirements for Active Substances used as Starting Materials
combined with GMP for APIs:
“How to do“ Document by APIC/CEFIC Interpretation of the ICH Q7 Guide
Chapter 8 Cleaning Validation
8.A Official requirements and agency expectations
Cleaning validation is not new, but the official requirements were updated in the revised Annex 15 in order to reflect the current state of the art. Three aspects are in the foreground:
- The lifecycle of the process should be taken in consideration.
- A quality risk management approach should be applied.
- Limits for the carryover of product residues should be based on a toxicological evaluation.
Michael Hiob, GMP inspector, gives a high-quality overview on agency expectations on cleaning validation. Every cleaning validation should be based on a defined cleaning process that is described in a cleaning instruction. The parameters that have to undergo mandatory validation are to be determined by a risk analysis. Limits have to be defined for product residues, cleaning agents and microorganisms. Sampling processes and analytical methods must be tested for suitability and/or validated in advance. The cleaning validation can be carried out on a selected worst-case example that is representative of a machine or product group. The documentation includes a validation plan and report. It should be ensured that the validation status is maintained on an ongoing basis. Changes must be evaluated to see if a revalidation is necessary. (Michael Hiob, PhD)
Chapter C EU Directives and Guidelines
C.5 EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials combined with GMP for APIs: “How to do“ Document by APIC/CEFIC Interpretation of the ICH Q7 Guide
APIC/CEFIC has updated its “How to do”-Document for the following Chapters:
- Chapter 6 Documentation and Records has been revised in the light of recent regulatory requirements on documentation, including ALCOA principles, document life cycle and data integrity.
- Chapter 8 Production and In-Process Controls (Changes in 8.15 on deviations of time limits)
- Chapter 10 Storage and Distribution (Changes in 10.20 on distribution procedures)
- Chapter 12 Validation was updated according to the revised Annex 15.
- A new Chapter 21 with comments to the ICH Q7 Q&A document was added to which we provide the corresponding links.