International Conference on Harmonisation (ICH), has issued a guideline on good manufacturing practices for active pharmaceutical ingredients (APIs). This is the updated ICH Q7 guideline in which the focus of the industry should be for the benefit of the patient in identifying the critical controls and procedures that assures the quality of the API.

The ICH established an Expert Working Group (EWG) which saw the need for the expansion of the document from beyond the three regions of USA, Japan and Europe to WHO, PIC/S members, India, China and OTC and generic industry representatives.

The EWG, of which CEFIC APIC was a member has compiled the 'GMPs for APIs' Guide in November 2000 and implemented within the three regions. The document provides examples of commonly applied solutions and practical assistance on how recommendations can be met.

The objective of the guidance according to ICH is to enable the industry avoid needless paperwork and administrative burden. The Q7 document focus is now directed for the benefit of the patient on identifying the critical controls and procedures that assure the quality of the API. Therefore, sound scientific judgment should prevail when setting up a quality system incorporating GMP.

The API industry has lauded the guidance as it brings in clarity on the systems to be put in place and in-turn creates more confidence when products are outsourced for formulation manufacture.

According to Prema Desai, pharma consultant, 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.

The Active Pharmaceutical Ingredients Committee (APIC) which is the European Chemical Industry Council (CEFIC) notes that 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.

Companies should be aware that the regulatory filing requirements could differ from the application of GMP as defined by Q7. There may be cases where more information may be required by regulatory authorities, indicated the guidance.

The companies are responsible for proposing the API Starting Material which is the registration of new APIs. However, based on current regulatory requirements it is likely that the regulatory authorities will require further information on API Starting Materials where only one or two synthetic steps exist between the API starting material and the API or where the API Starting Material is an API itself.

The regulatory authorities may also require further details for late stage API Starting Materials, though recent examples are known that in specific cases FDA has accepted final intermediates as API Starting Materials like for instance the commercially available substance 6-APA for the manufacture of semi-synthetic penicillins.

In order to be in compliance with regulations, the guidance also gives importance to quality systems, environmental controls and safety. Business efficiency and continuous improvement are needed to be competitive. Therefore GMP compliance should be incorporated into an overall quality management systems (QMS). All electronic or manual records that are used for GMP requirements of ICH Q7, data integrity needs to be maintained.