
ICH Moves Q7 Q&A Guideline on APIs to Implementation Stage
The International Conference on Harmonization finalizes Q&A document on APIs.
The International Conference on Harmonization (ICH)
Topics clarified in the
- Quality management. ICH addresses questions on the meaning of 'quality unit(s) independent from production'; expectations of the quality unit regarding API release testing and sampling; and product quality reviews.
- Personnel. Answers to questions regarding personnel include assessment of training; the use of consultants; and dedicated production areas.
- Buildings and facilities. ICH clarifies confusion about dedicated production areas and the use of quality risk management.
- Equipment cleaning. Questions regarding the cleaning of process equipment address the acceptance of the term ‘visually clean’; acceptance criteria for residues; cleaning time limits; cleaning validation; and product changeover.
- Record keeping. ICH clarifies record retention; batch numbering systems; and batch production records.
- Materials management. A number of items are clarified regarding materials management, including supplier evaluations, on-site audits of suppliers, identity tests, and expiry dates.
Other topics discussed include production and in-process controls; storage and distribution; laboratory controls; validation; change control; and contract manufacturers.
The Q7 Q&A document can be found on ICH’s guideline
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