Excipients are a diverse range of materials from many origins. Some are produced especially for pharmaceutical product use, but in many cases the main market for the materials is not pharmaceutical, and only a small proportion of the global production is actually used as excipient. There is a regulatory expectation that pharmaceutical companies will properly verify that the excipients that they use are produced by their suppliers to an appropriate level of GMP. This has historically been done by auditing some of those suppliers, however in today’s world the burden that generates both on suppliers and pharmaceutical company users is impractical and unsustainable.
One solution for verification of suitable GMP is the use of certification schemes, though these must be independent and of demonstrable credibility. Regulators have already indicated that such approaches would be acceptable, provided the scheme met the requirements of such demonstrable credibility. For a certification scheme to meet these requirements there are three basic premises:
- Assessment must be to a suitable recognised and published standard.
- The auditor must be demonstrably competent to undertake the assessment of an excipient manufacture against the standard.
- The Certification Body must have quality management systems suitable for providing such services; conformity to ISO 17021 is the basic tenant here.
The EXCiPACT initiative, launched in 2014 was designed to fulfil these objectives. EXCiPACT is a ‘not for profit’ organisation comprised of a number of industry associations with members from both the excipient manufacturer and user communities; as such it is an ‘association of associations’ and independence is assured. EXCiPACT is the owner of the standard, and has oversight of registered auditors and Certifying Bodies. The scheme is finding great favour in the industry with all parties, including Regulators, and has already taken the place of many potential individual customer audits.
Register for this webinar and you will learn the important facts that determine the credibility of independent certification schemes, and how EXCiPACT certification can benefit both manufacturers and pharmaceutical users of excipients, whilst at the same time saving cost in supplier qualification.
Kevin J McGlue CSci, CChem, MRSC
Director Global Quality Assurance, Colorcon / President, EXCiPACT asbl
Kevin is a graduate in Chemistry and started his working career first as a Research & Development Chemist, then as a Process Chemist.
He then spent six years as a Chemical Synthesis Plant Manager, and Formulations & Packing Manager managing a wide range of chemical synthesis and formulation activities for Schering A.G.
He joined Colorcon in 1987, spending 11 years as Operations Manager and 8 years as Operations Director responsible for all Operational activities for Colorcon EMEA. In February 2006 he took up a new position as Director, Global Quality Assurance with overall responsibility for all QA and QC activities worldwide.
Kevin is President of EXCiPACT asbl. He is a former member and vice-chair of the Board of IPEC Europe and a past chair of the IPEC Europe GMP committee. He was a member of the IPEC team responsible for the production of the 2006 Joint IPEC / PQG Excipient GMP guide, and led the task force for the 2017 revision. Kevin has published numerous articles on Excipient GMP and Change Management and is a regular speaker at seminars, conferences and training courses.
- The importance of appropriate GMP for excipients
- The critical factors that determine the suitability of independent certification schemes
- The benefits of independent certification to both manufacturers and users of excipients
- Heads of Supplier Qualification
- Procurement Heads and Specialists
- QA Managers
- QA Directors & Managers
