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Pharma slow to adopt third-party certification?

Published on 23/08/13 at 01:48pm

A survey has found that while industry likes the idea of using third-party auditors to help them assess the quality of ingredients used in drug products, take-up of these services remains limited.

The first-ever survey from CPhI PharmaEvolution on formulation challenges found that 55% of 123 pharma professionals said they felt third-party auditing was ‘extremely important’, while 39% it was ‘somewhat important’.

The poll also revealed however that more than three quarters of the respondents (75.6%) said they were not working with third-party auditors to assess suppliers' quality, indicating a ‘disconnect between intent and action’, according to the report.

The survey also found that around half of those surveyed indicated that active pharmaceutical ingredient (API) and excipient quality was a major issue facing formulators.

Certification by third-parties can gives drugmakers a level of assurance that a supplier is meeting relevant Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards, without necessarily having to carry their own on-site audit.

Commenting on the finding, Irwin Silverstein of US auditing organisation IPEA said: “If [companies] are not working with third-party auditors to verify supplier compliance with GMPs, how can they ensure that suppliers meet their expectations for GMP compliance?”

He went on: “They can’t all be auditing all their suppliers. There’s not enough time in the year for suppliers to host all of their pharma customers.”

Among the respondents, around 31% of those who said they were already using third-party certification said they were using the Verified Ingredients Program operated by the US Pharmacopeial Convention (USP), with around 18% citing use of the IPEC Federation’s EXCiPACT programme and 10% working with IPEA.

Nevertheless, the statement of intent is still good news for third-party certification schemes, including EXCiPACT which has just emerged from the pilot phase of its operations and has now completed its first two certifications, for Merck KGaA’s EMD Millipore unit and Hedinger.

The report also found that quality by design (QbD) and process analytical technologies (PAT) are only being used by a third of the industry, with two-thirds: “Waiting to see if QbD really works…when the concepts have already been proven to work in every other industry in the world, from cake mixers to cars,” according to near infrared spectroscopist and PAT expert Emil Ciurczak, who serves on CPhI's advisory board.

Phil Taylor

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