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ICH Expands Guidelines for Active Pharmaceutical Ingredient GMPs

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GMP Guidelines

The guidelines stress the importance of appropriate controls, to ensure the APIs are of high quality and are maximally beneficial to the patient.

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October 14, 2015 | by Sarah Massey

The International Conference on Harmonisation (ICH) recently released their Q7 guidelines on good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs). The guidelines stress the importance of appropriate controls, to ensure the APIs are of high quality and are maximally beneficial to the patient.

A subcommittee of the ICH – the Expert Working Group (EWG) – was responsible for making the document applicable outside the US, Japan and Europe – the countries for which the document was originally written. The updated guidelines have now been expanded to include China, India, the World Health Organization, The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) members, as well as representatives from the generics and over-the-counter (OTC) drug industries.

A group within the European Chemical Industry Council – the Active Pharmaceutical Ingredients Committee (CEFIC APIC) – along with other members of the EWG, originally composed the ‘GMPs for APIs’ Guide in November 2000. The guide compiles a number of solutions to commonly encountered problems, and provides examples on how industry recommendations can be met.

The guidelines put forth in the ICH aim to reduce the administrative burden on manufacturers, and minimize the amount of paperwork that must be completed. The reception of the document within the industry has been positive, giving manufacturers clear ideas on how to implement a GMP and increasing confidence in formulation manufacturing outsourcing.



According to a ‘How-To’ document produced by CEFIC APIC, “The adoption of the guidance will provide both industry and regulators with a much greater confidence in the quality of global bulk active pharmaceutical ingredients manufacture.”

While the new guidance should provide manufacturers with clarity on GMPs for APIs, the document warns that regulatory filing requirements could be different compared to those outlined in the Q7 update. Some instances may require more submissions to regulatory authorities, compared to the guidelines provided in the document.

While formulation companies must register new APIs – and specify their starting material – regulatory bodies may also require additional information regarding the proposed APIs. More details may need to be provided when the starting material is also an API, and when the starting material is one or two synthetic steps away from the API.

The updated document also provides information on environmental controls, safety and quality systems, in order to promote compliance. The ICH Q7 stresses that a quality management system (QMS) should be employed to organize all aspects of a compliant environment, including GMP compliance.

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