Diapharm now provides over 500 GMP audit reports

The pharmaceutical service provider Diapharm’s third-party audit service (uk.diapharm.com/audits/) has now exceeded the mark of 500 current GMP audit reports. On behalf of the pharmaceutical industry, auditors check on site whether suppliers of active pharmaceutical ingredients (APIs) worldwide are complying with Good Manufacturing Practices. From the manufacturing of acetylcysteine in Spain to zolmitriptan in India, almost all of Diapharm’s audit reports are available for purchase. A small amount of audits are performed exclusively for individual clients.

Certified monitoring as opposed to individual audits

Pharmaceutical companies are required to regularly monitor GMP compliance when it comes to the manufacturing of their APIs and excipients. This monitoring also needs to be repeated at regular intervals by way of re-audits. As a result, major API suppliers in India and China receive up to 100 audit requests from their clients every year. “Our third-party audit service offers an ideal structure for this form of GMP monitoring,” says Ralf Sibbing, General Manager of Diapharm. “We reduce the number of audits while providing the highest quality of audit reports.”

blue inspection body GmbH, Europe’s first ISO 17020-accredited provider (type A) of inspections of starting-material and API manufacturers, performs the on-site audits on behalf of Diapharm. “This strict separation of monitoring and service ensures that our third-party audits are performed in an absolutely independent and unbiased manner. That is why authorities worldwide accept these audits,” Ralf Sibbing emphasises. The accredited third-party audit reports from Diapharm are on a par with audits by pharmaceutical companies’ qualified persons. Diapharm offers its audit service worldwide in seven languages.

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