Distributors of active pharmaceutical ingredients in Europe should build quality management systems that include the same features as drugmakers’ QMS in areas such as contamination control and documentation, according to a new reference guide on good distribution practices.

The guide from the Brussels-based Active Pharmaceutical Ingredients Committee (APIC) includes calls for distributors’ facilities to be designed to minimize contamination risks by complementing the flow of personnel and materials. Facilities should include defined areas for receipt, identification, sampling and quarantine of incoming products. The buildings also should have appropriate ventilation, air filtration and exhaust systems that control humidity, air pressure, dust and temperature, especially in areas where APIs are exposed.

Staff should ensure all instruments are accurately calibrated, APIC said, with certificates maintained and records open to operating personnel. Ensuring equipment cleanliness should be done by testing the final rinse after cleaning residue or by testing each batch for residue of previous products handled with the same equipment, among other things.

For labeling APIs, the guideline recommends following the World Health Organization’s recommendations requiring the name of the pharmaceutical starting material, the grade and pharmacopeias, international non-proprietary names, amount, batch numbers, retest or expiry dates, storage conditions and handling precautions and identification of manufacturing sites, along with contact information.

Managers should keep records of all procedures and conduct internal audits at least every year, the guide says.

The focus on API compliance is crucial as drugmakers operating in the EU are required to use only active substances distributed in accordance with the Falsified Medicines Directive.

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