Rx-360 has released a range of documents which are very useful in daily practice. Regarding the topic "Auditing", three new Audit Guides have been developed. These guides are structured as checklists which makes their use very easy. The following guides have been released:
Rx-360 Audit Guide for Pharmaceutical Packaging Materials
Rx-360 Audit Guide for Pharmaceutical Chromotography Resins
Rx-360 Audit Guide for Pharmaceutical Excipients
The checklist for pharmaceutical excipients is based entirely on the new certification standard EXCiPACTTM. The Audit Guide is a useful tool which can be used within the EXCiPACT certification programme. The GMP requirements - which were originally published by the IPEC - are the basis. As many companies from the excipient industry are already ISO 9001 certified, the checklist is structured like this standard.
The new EXCIPACTTM standard will be presented at this year's Merck Pharma Forum on 12 June 2012 in the Merck Headquarter by Dr Iain Moore, leader of the IPEC working group.
Source: Rx-360 Press Release
EXCiPACT is a trademark by the the EXCiPACT Association.