Whether you are an excipient user, producer, or distributor, IPEA offers programs with layered benefits that can help your department or company in a variety of ways. Even companies with existing audit programs will find our services effective in dealing with the new demands for excipient specific cGMP audits.

In the IPEA program you will find:

• Reliable, independent third party audits of excipient manufacturers
• Strict code of ethics and standards with regards to all proprietary information
• Expert auditors whom have trained and successfully completed a comprehensive IPEA auditor training program.
• Auditing adherence to recognized IPEC, ISO, WHO and USP principles of cGMP
• Strong local and international auditing capabilities
• Auditors from worldwide geographic locales with fluency in local languages and customs
• Confidence that global audit deadlines will be met in face of unpredictable world safety conditions (SARS, terrorism, etc)
• Security in knowing our excipient audits and assessments test for conformance to industry accepted standards (as defined in IPEC cGMP Guide, ISO900 1/2000 and current USP/NF chapter)
• Interested audit report purchasers are identified only to the relative excipient manufacturer.
• Complimentary overnight express mail delivery of reports to customers.
  

Benefits for:
Pharmaceutical and Nutriceutical Manufacturers

• Conservation of company manpower and time
• Auditors from worldwide geographic locales with fluency in local languages and customs
• Convenient, prompt assessments on excipient manufactures through Audit Reports
• Fewer sites to audits with utilization of Audit Report program
• Audit confidentiality, audit requester disclosed only to excipient manufacturer
• Cost savings on new audits & existing reports

Excipient Manufacturers

• Fewer site visits by excipient customers when you have Audit Reports available
• Shorter and more focused visits by excipient customers who have reviewed your audit report
• Utilization of site assessments as gap analysis
• Observations provide you with an accurate overview on how your compliance relates to industry standards
• Security that you have opportunity to review report draft for any factual errors, omissions, and confidential information before report is finalized.
• Confidence that, if needed, any corrective and preventive action plans will be included as an addendum to an audit report before a final copy is sent to the Sponsor.
• Quality review of each completed audit report by IPEA audit specialists who insure consistent and appropriate application of IPEC excipient GMP requirements.
• Opportunity to use audit reports to establish to customers your compliance to appropriate GMP requirements.
• Independent and impartial IPEA assessments help gain customer confidence in your quality system
• Audit Reports are never sold without notification and approval of the audited manufacturer

Excipient Distributors

• An alternative to arranging repetitious site visits for different excipient buyers.
• A solution to your customers who purchase insufficient quantities to convince the excipient site to host an audit.
• A tool for you to know whether the excipients you are supplying to customers is indeed being manufactured under cGMP.
• A valuable source to help you provide pharmaceutical & nutriceutical customers with information they need to meet excipient assessment requirements.