IPEA GMP Certification Program Accredited by ANSI
IPEA has received accreditation of its excipient certification program from the American National Standards Institute (ANSI). Accreditation of the program, officially called the IPEA Excipient GMP Conformance Certification Program, by ANSI, signifies conformance to the International Organization for Standardization (ISO)/IEC Guide 65 on general requirements for companies and organizations operating product-certification systems.
Excipient GMP Audit Program
IPEA offers third party audits to facilitate the assessment of excipient manufacturers to appropriate current Good Manufacturing Practice (cGMP) guidelines. Audits of excipient manufacturing sites are performed on a worldwide basis. Audit findings are presented in an Audit Report which is intended to provide a basis for confirming that the quality system used to produce the audited excipient meets appropriate cGMP.
Excipient GMP Conformance Gap Assessments
This program identifies and evaluates the significant audit findings in an IPEA audit. Within this service, IPEA assists manufacturing facilities with implementing any necessary corrective and preventive measures that appropriately address deficiencies in the excipient GMP compliant quality system.
Qualification of Excipient Auditors
IPEA auditors are qualified after completing:
- Comprehensive auditor training by experienced auditors with excipient and pharmaceutical drug product manufacture expertise.
- Thorough training in standards from the globally recognized Joint IPEC-PQG Good Manufacturing Practices Guide and Audit Guide for Pharmaceutical Excipients
- On-site audits of actual excipient-producing facilities or simulated classroom audit exercise
- Completion of an observed audit including report
Excipient GMP Auditing Workshops
IPEA offers workshops which train auditors in assessing excipient manufacturer conformance to appropriate GMP requirements. General or specific excipient GMP workshops can be customized for your site.
This program affords excipient purchasers the opportunity to verify supplier excipient GMP conformance without the trouble, time and expense of initiating an audit. Also, this program benefits excipient suppliers who want to demonstrate, through an Audit Report, cGMP manufacturing conformance to potential customers and to set themselves apart from their competition.
On Site Excipient GMP Training
Needs-specific training in excipient cGMP conformance for facilities wishing to further enhance their quality assurance departments.
For details specific to your needs, please address questions to the attention of:
Dr. Irwin Silverstein, IPEA/COO at firstname.lastname@example.org