I supply excipients to the Pharmaceutical Industry. What benefits do I reap from this audit service?
As a supplier sponsor of an audit, you can save yourself valuable time normally spent hosting repetitious customer audits which seek the same information. Once a supplier has an audit on record with IPEA, they may simply inform present and future customers of the availability of this independent audit. A supplier's customer would be able to purchase the audit from IPEA at considerable savings in both time and expense over performing the audit themselves or paying to have it done.
As a pharmaceutical company, what benefits do I get from this service as a sponsor?
As a pharmaceutical manufacturer, you are required to assess the conformance of excipient manufacturers to appropriate GMP requirements. IPEA provides a cost effective means to perform this assessment without visiting the site:
- Purchase an existing audit report or
- Sponsor an audit and receive credit each time the report is sold and avoid the costs for travel in terms of your time and expenses
As an audit sponsor, is my name ever associated with the resale of the audit report?
IPEA never discloses the name of an audit sponsor. It is considered confidential information.
As an excipient supplier, I do not want my competition to have this audit information. How do you prevent this?
Audit reports are kept confidential. If anyone wants to purchase an existing audit report of your facility, IPEA contacts you before the audit is sold and affords you the opportunity to prevent the report from being sold to a competitor.
As an excipient supplier, what assurance is there that the report is factually correct and free of confidential information?
The excipient manufacturer is given 10 business days to review the draft report before it is finalized. Your feedback will be used to correct errors, remove any confidential information, and to include your corrective action plan if so desired.
For details specific to your needs, please address questions to the attention of:
Dr. Irwin Silverstein, IPEA/COO at firstname.lastname@example.org