Report On Experiences with Excipient Audits

The industry initiative EXCiPACT was launched a year ago to improve monitoring of pharmaceutical excipients. At the CPHI China in Shanghai and the ExcipientFest Europe in Amsterdam, the auditors of blue inspection body have now drawn an initial conclusion: “Overall, the level of awareness for good manufacturing and good distribution practices at excipient manufacturers has increased significantly in the past 12 months,” declared lead auditor Dr Norbert Waldöfner in a presentation at the IPEC China Excipient Regulatory and Quality Control Seminar during the CPHI in Shanghai. “This is certainly partly due to the fact that the regulatory authorities have placed a stronger focus on the topic.” Shortly before, one of blue’s shareholders, Dr Stefan Kettelhoit had already informed the participants at the ExcipientFest congress Europe in Amsterdam about the experiences with the first EXCiPACT audits.

One difficulty with audits of excipients such as lactose, cellulose or glycerol is that GMP and GDP standards do not apply to all parts of the company being audited, explained Dr Norbert Waldöfner: “In many cases, only a small part of production is destined for the pharmaceutical industry.” In such cases, documentation of the respective batches is particularly important.

EXCiPACT initiative aims for certified monitoring of excipients

The EXCiPACT initiative was established by industrial associations of excipient suppliers and the pharmaceuticals industry. The aim is to merge and standardise surveillance audits of Good Manufacturing and Good Distribution Practice of pharmaceutical excipients. “The slogan is ‘Less but more professional audits’, meaning that EXCiPACT has defined particularly high standards for every single audit”, explained Dr Stefan Kettelhoit from blue inspection body GmbH: “This ensures that third-party audits of excipient manufacturers are also internationally recognised by regulatory bodies.” In the past, pharmaceutical companies conducted their own audits, which meant that excipient manufacturers were sometimes confronted with over 100 audit requests from different customers.

CPHI China and ExcipientFest Europe

CPHI China is part of CPHI Worldwide. With around 30,000 visitors from 102 countries, the trade fair in Shanghai is one of the largest events for contract manufacturers and exporters of pharmaceutical products worldwide. The ExcipientFest congress is specifically aimed at producers and users of excipients for the production of medicinal products. It is staged alternately at venues in the United States, Europe and Asia.

The blue inspection body GmbH examines the Good Manufacturing Practices (GMP) of pharmaceutical companies around the globe. Third-party audits by blue efficiently relieve manufacturing authorisation holders, API suppliers and API manufacturers. Blue inspection body GmbH is the first independent and accredited service provider for GMP audits in the European Union.