Webinar: Global Pharmaceutical Excipient Manufacturing & Distribution Certification

Maximises the Benefits and Minimises the Risks with EXCiPACT Approved Audits

How can EXCiPACTâ„¢ Certification help Qualify Excipient Suppliers?

EXCiPACTâ„¢ Certification scheme is designed as a way to reduce the audit burden for excipient producers, suppliers and pharmaceutical companies.

The EXCiPACTâ„¢ Certification has been developed by 5 industry associations comprising excipient manufacturers, distributors and users; EFCG (European Fine Chemicals Group), IPEC-Americas, IPEC Europe, FECC (Federation of European Chemical Distributors) and the UK PQG.

The Certification is based on the well-known IPEC-PQG GMP and IPEC GDP Guides. This has been converted from a "how to do" document style into a "what to do" standard, which makes for more objective audits and assessments.

EXCiPACTâ„¢ Standards comprises:

- An assessment standard which is used in conjunction with an ISO 9001 audit to determine compliance to excipient GMPs

- An assessment standard which is used in conjunction with an ISO 9001 audit to determine compliance to excipient GDPs

- An auditor competency definition and set of requirements which is built as an Annex to ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing.

- A set of requirements for the 3rd party audit organisation QMS based as an annex to ISO 17021:2006, Conformity assessment requirements for bodies providing audit and certification of management systems.

This webinar will be exploring the value to supply chain, how and why you would want to apply set new standards and how excipient suppliers gain leverage from their existing quality management systems (QMS) to minimise their investment in revising the QMS.

The 1 hour - free - presentation will be exploring all facets within EXCiPACTS initiative which was based on well-known ISO certification model, but enhanced to eliminate the weaknesses in some ISO schemes. The proceedures it suggests allow for direct customer-supplier communication and relationship. Moreover, EXCiPACTâ„¢ as a non-profit organisation acts independently from the 3rd party audit organisations and giving objectivity in the assessments and maximising impartiality. The system factors in cost effectiveness to all parties concerned, so log in to one of the remaining places now to find out how and why this is done.