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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 on 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.
IPEA can arrange audits in over 90 countries
through a strong international network. Domestic
and overseas audits are performed by IPEA trained
and certified personnel who are conversant in
most local languages.
Our programs benefit pharmaceutical-nutriceutical
manufacturers and excipient producers-distributors
through cost effective multi-faceted services.
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We offer:
- Prompt and Confidential
Response to Audit Needs
- Objective Audit and Compliance Reports
- Short and Long Term Cost Savings
- Enhanced Audit Program Management
- GMP Compliance Status Assessments
- Application of Excipient GMP Requirements
- Independent Compliance Reports for Customers
- Off-site Expert cGMP Training & Workshops
- On-site Tailored cGMP Training & Workshops
- Quality System Development
- Document and Record Verification
- Control System Evaluations
- Risk Assessments
- Certified Excipient Auditors
- Supplier GMP Status
- Industry Acceptance
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