How EXCiPACTâ„¢ Certification Scheme helps reduce the audit burden for pharmaceutical excipient users and suppliers
Regulatory authorities continue to focus on pharmaceutical grade excipients and require them to be manufactured and supplied according to GMPs. Not only have there been draft guidances issued in Europe and the USA on the subject but also in China and Brazil. These critical components of drug products have until recently been considered a low risk to patient safety but the continued falsification of medicinal products and their ingredients in the past 10 years has put them firmly on the regulatory agenda. One key element in all the regulatory oversight is that the drug product manufacturer is responsible for ensuring that the excipients they use are manufactured to the appropriate GMPs.
So how can a drug product manufacturer determine that the excipients they use have been manufactured to GMP? The traditional method is through supplier audits. But these require substantial resources to conduct, both in qualified personnel and financially. Equally, many excipient suppliers are no longer able to accommodate the ever increasing demand for audit requests and have started to decline or ration audits.
The Webinar will highlight the developing regulatory requirements and demonstrate how the EXCiPACTâ„¢ Certification Scheme for GMP and GDP for excipients, which is now fully implemented, provides an effective means of qualifying and re-qualifying pharmaceutical excipient suppliers.
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.
Presented by
Iain Moore,
Chair, EXCiPACTâ„¢ Certification Project
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 EXCiPACTâ„¢ Certification Project.
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Key Learning Objectives
- How EXCiPACTâ„¢ Certification Scheme works
- How EXCiPACTâ„¢ Certification and Audit Reports help qualify excipient suppliers
- How can I get an EXCiPACTâ„¢ Certificate
- Why you should be using EXCiPACTâ„¢ Certification
Audience
- Purchasing (decision makers)
- Quality Assurance
- Regulatory Affairs
- Project Managers
- Formulators
- Sales and Marketing
- Operations
