Certification

Register for the 2010 IPEA Auditing Workshop
One Day Workshop
Excipient Significant Change
March 23, 2010
Washington DC Metro area
One Day Workshop
Validation
March 24, 2010
Washington DC Metro area

Three Day Workshop

IPEA Excipient GMP Auditing Course
June 8-10, 2010
Newark, NJ area
Audit Reports
Available for purchase


International Pharmaceutical Excipients Auditing, Inc. provides current good manufacturing practice auditing services to the pharmaceutical, chemical, and nutriceutical industries to facilitate the assessment of excipient manufacturers to appropriate GMP requirements. Audits follow recognized IPEC, ISO, WHO, and USP principles of cGMP for excipient ingredients.IPEA audits record observations at excipient manufacturing sites. Audit reports provide a basis for pharmaceutical and nutriceutical manufacturers and distributors to evaluate the adequacy of an excipient manufacturers' quality system to appropriate excipient cGMP requirements.Domestic and overseas audits are performed by IPEA trained and qualified personnel who are often conversant in the local language.

Our programs benefit pharmaceutical-nutriceutical manufacturers and excipient producers-distributors through cost effective multi-faceted services.

We offer:

  • Prompt and Confidential Response to Audit Needs
  • Objective Audit Reports
  • Short and Long Term Cost Savings
  • Enhanced Audit Program Management
  • GMP Conformance Gap Assessments
  • Application of Excipient GMP Requirements
  • Independent Conformance Reports for Pharmaceutical Customers
  • Public cGMP Training & Audit Workshops
  • On-site Tailored cGMP Training & Workshops
  • Quality System Development
  • Document and Record Verification
  • Control System Evaluations
  • Risk Assessments
  • Qualified Excipient Auditors
  • Supplier GMP Status
  • Industry Acceptance

 

 

 

Free Sample Audit Report