Fine Chemicals Group Offers Commonsense Steps

Simple Guide

New European Union legislation went into effect on Oct. 31, 2005, requiring that drug producers vouch that the active pharmaceutical ingredients (APIs) in drugs are compliant with Good Manufacturing Practices. The European Fine Chemicals Group (EFCG) is offering a simple three-step set of guidelines to help drug manufacturers determine if they are using APIs from a GMP-compliant source. According to EFCG, all compliant API producers and suppliers should be able to provide drugmakers with the following documents as proof:

◾ A written and signed declaration certifying that each API supplied is made under GMP to the requirements of the international regulation ICH Q7a as described in the drug master file filed with a country's health authority or with the European Directorate for the Quality of Medicines. Any changes from established production and process control procedures that can affect quality should be provided in writing before being implemented.

◾ Updates of the following three reports: a signed summary report demonstrating that an annual product quality review under ICH Q7a was performed by the supplier for the API in question, an annual stability report, and an annual report on change control related to changes from established production and process control procedures that can affect quality.

◾ Evidence of inspections by reputable health authorities showing that inspectors visited the plant where the API is manufactured and issued a favorable comment on the level of compliance with GMP.

Besides requiring the above-mentioned documentation to be on file for every API used in formulating medicines for sale in the EU, EFCG recommends that drugmakers should also have an audit report on the manufacturer for each API that is no more than three years old. Complicating the matter, however, is that the health authorities in Europe have not yet clarified the structure and specifics of such audits; EFCG is working to help create guidance and develop a third-party audit system.