With excipient suppliers expecting a tsunami of audit requests, insufficient trained auditors in the field and the potential for this to dilute resources from higher risk issues, the solution was a certification scheme acceptable to the industry and regulators. The  authorities on both sides of the Atlantic have so far indicated that the use of properly trained and administered third party audits is acceptable.

The second draft of Excipat has been issued and comments are currently being reviewed with incorporation expected soon. Excipact is being registered as a legal entity, not for profit organisation.We are currently discussing auditor training with the Excipact executives and will be updating our courses in Europe, the Far East and Europe.

It would appear that with the right marketing these standards would have a bright future here. There is certainly a need for them and well trained auditors as witnessed by the regular press reporting of contaminated products, fraudulent adulteration and patient deaths. The penalties for the perpetrators can be draconian but there is no substitute for preventive action in the supply chain which auditing to these standards can provide.

The findings from each audit should be documented, and audit reports should be available for review by Inspectors.