ICH Moves Q&A Document on GMPs for APIs to Implementation Stage

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-22-2015 11:42


The International Conference on Harmonization (ICH) reports that the ICH Q7 Questions and Answers on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients reached Step 4 of the ICH Process in June 2015 and now enters the implementation period (Step 5). Step 4 is reached when the ICH Steering Committee agrees that there is sufficient consensus on a draft guideline. The Step 4 Final Document is signed-off by the Steering Committee signatories for the regulatory parties of ICH as an ICH Harmonized Guideline at Step 4 of the ICH process. Step 5 is regulatory implementation. This step is carried out according to the same national/regional procedures that apply to other regional regulatory guidelines and requirements, in the European Union, Japan, the Unites States, Canada, Switzerland and beyond.

According to ICH, experience gained with the implementation of the ICH Q7 Guideline since its finalization in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs, also in context with new ICH Guidelines ,are addressed in this Question and Answer document in order to harmonize expectations during inspections, to remove ambiguities and uncertainties, and also to harmonize the inspections of both small molecules and biotech APIs.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) contributed to the ICH document by selecting and reviewing relevant Q&As that had been collected from training sessions since the implementation of ICH Q7 and transferred the output of these reviews to the ICH Q7 Implementation Working Group for consideration and consolidation. Additional questions were developed based on responses from an ICH survey. PIC/S further contributed to the development of the document as an ICH Interested Party.

Source: ICH


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