Benefits of Membership
Become a member of IPEC Europe and in return receive a whole host of benefits
Benefits of Membership
Benefits of IPEC Europe membership include:
- Access to globally accepted industry guidance documents covering:
- International good manufacturing practice principles for pharmaceutical excipients;
- GMP auditing of excipient suppliers and distributors
- GDP auditing of excipient suppliers and distributors
- Format and use of excipient certificates of analysis
- Identification and reporting of significant changes which occur during excipient manufacture.
- Standardised excipient information to help suppliers and users better evaluate excipients for pharmaceutical use.
- Submission and maintenance of data for Type IV excipient drug master files excipient composition and essential elements of the excipient qualification and specification development processes.
- Access to audit reports of excipient supplier and distributors’ practices generated by the GMP auditing program that is managed and administered by its subsidiary company, International Pharmaceutical Excipients Auditing, Inc. (IPEA)
- Opportunity to have member company auditors trained to conduct excipient supplier and distributor audits based on the Joint IPEC/PQG GMP Guide for Pharmaceutical Excipients and companion Audit Guidelines
- Access to and ability to influence USP, PhEur and JP decisions and directives by service on compendia working groups and expert committees.
- Access to FDA, USP, and other industry organizations through involvement with CHPA, Product Quality Research Institute (PQRI) and ASTM International projects and committee service.
- Access to the members-only sections of the IPEC-Europe website to comment on IPEC draft monographs, position papers and policy statements; to register for meetings and to view IPEC publications.
- Obtain discounts on IPEC seminars and conferences.
- Through collaboration with IPEC-Americas, IPEC Europe also have:
- Opportunity to work with FDA to improve the content and format of the agencies inactive ingredient guide and its Type IV drug masterfile system.
- Access to FDA, USP, and other industry organisations through involvement with CHPA, Product Quality Research Institute (PQRI) and ASTM Internationanl projects and committee service.
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