ICH Moves Q7 Q&A Guideline on APIs to Implementation Stage

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The International Conference on Harmonization finalizes Q&A document on APIs.


The International Conference on Harmonization (ICH) announced on June 19, 2015 that Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Questions and Answers has reached Step 4 of the process and now enters into Step 5, the implementation stage. The Q&A document addresses confusion regarding interpretation of the Q7 guideline and aims to harmonize expectations during inspections of both small molecules and biotech APIs.

Topics clarified in the Q&A document are varied. The following are some of the answers ICH provides:


  • 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 webpage.

Source: ICH.org