How EXCiPACTâ„¢ Certification Scheme helps reduce the audit burden for pharmaceutical excipient users and suppliers
The audit expectations of regulatory authorities all over the world include all excipient suppliers and audits that are conducted regardless of whether you are innovative, generic or even an OTC pharmaceutical company. These expectations push the limits of what is current practice and place a great burden on all parties concerned, not least the excipient suppliers themselves. What can you do when your supplier indicates they cannot accept your audit requirements?
The authorities have indicated that 3rd party audit schemes are acceptable, but just what kind of features in these schemes do you need to see to have confidence in their credibility? The recent publication of the EU guidelines on ascertaining the GMP required for an excipient manufacturer lays down the key principles and processes for using a risk based approach to excipient supplier qualification. Included within the guidelines is the ability to use supplier certification as item in the risk assessment balance when determining the suitability of the supplier. In Europe these new guidelines place even more duties on already over stretched Qualified Persons.
The webinar will highlight the core features of a credible 3rd party audit scheme and compare the EXCiPACTâ„¢ Certification Scheme against these. The use of the risk assessment to determine an excipient suppliers suitability will also be highlighted and the use of a suitable 3rd party Audit report like those from EXCiPACTâ„¢ Certified suppliers will be demonstrated.
So, if you manage a supplier audit program, or are an auditor or host GMP audits then sign up to this webinar to learn how the EXCiPACTâ„¢ Certification scheme can help you maximise the benefits whilst minimising the risks. The webinar will be equally interesting to excipient suppliers and to those Certifying Bodies intending to offer EXCiPACTâ„¢ Certification as it will show how the Certificates and Audit reports can be used to best effect by the pharmaceutical excipient users.
Presented by
Iain Moore,
Chair, EXCIPACTâ„¢ Board of Directors
Iain Moore is Global Head of QA at Croda in the UK where he has held a number of sales, technical and quality assurance roles during the last 25 years. He has installed excipient and API GMPs, with two successful MHRA inspections.
He is a co-author of the PQG PS 9100:2002 guide for pharmaceutical excipients, the IPEC-PQG GMP Guide for Pharmaceutical Excipients and the EFfCI GMP Guide and standard 2012 for Cosmetic Ingredients, as well as Chair of the EXCiPACT Board of Directors.
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Key Learning Objectives
- Key features for a credible and reliable 3rd party Certification Scheme
- How EXCiPACTâ„¢ Certification and Audit Reports help qualify excipient suppliers
- How I can I get an EXCiPACTâ„¢ Certificate
- Why you should be using EXCiPACTâ„¢ Certification
Audience
- Pharmaceutical companies
- Purchasing decision makers
- Quality Assurance
- Regulatory Affairs
- Project Managers
- Formulators
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Excipient Suppliers
- Sales and Marketing
- Operations