Benefits of EXCiPACT Certification

Filmed on March 20, 2024 - EXCiPACT and EXCiPACT Pharmaceutical Auxiliary Material are certifications that are under high demand. In a recent webinar, our expert speakers covered the ways that EXCiPACT adds value to suppliers and users of excipients. This webinar explains how the EXCiPACT Scheme relates to GMP, GDP, GWP & PAM Standards, how suppliers can best prepare before audits, train their staff, what the audit will entail. We also share some of the most common challenges and best practices to set your team up for success.
The objective of this webinar is to explain how EXCiPACT certification adds value to suppliers and users of excipients.
0:00 Introduction
7:12 What are Excipients?
8:08 Who and What is EXCiPACT asbl?
9:33 What is EXCiPACT Certification?
11:23 What are PAMs?
13:37 Application of EXCiPACT by Excipient Suppliers
16:48 EXCiPACT GMP Risk Assessments
17:51 How to use EXCiPACT & Meet Regulatory Requirements
23:58 Difference Between a Standard & a Guide
26:45 How EXCiPACT asbl Assures the Quality of Certification Audits
29:38 Who Requires EXCiPACT Certification
33:36 How to Use EXCiPACT Certificates & Audit Reports
35:15 What Does the Certification Process Include?
38:21 Pre-Audit
38:59 Stage 1 Audit
40:26 Stage 2 Audit
42:25 Surveillance or Renewal Audit
43:43 Common Non-Conformances
49:04 Q&A
Speakers
Iain Moore - Senior Advisor, EXCiPACT
Jon Gawlak - Technical Manager/Senior Auditor, SGS North America
John Armstrong - Regional Sales Manager, Pharmaceuticals, SGS North America Inc.
Learn more: bit.ly/3W6xi45
Follow us on LinkedIn: bit.ly/44lmAY1