Case Study 18: API Manufacturer Audit for a Canadian Generic Drug Company
Client: A Canadian generic drug manufacturer
Challenge:
The client needed to audit an Indian API manufacturer for compliance with Health Canada and WHO GMP guidelines. Budget constraints and travel restrictions heightened the need for a cost-efficient solution.
Solution by Qualifyo:
- Deployed a local auditor with experience in Health Canada GMP compliance, avoiding international travel costs.
- Conducted a one-day on-site audit focusing on API manufacturing processes, stability studies, and documentation practices.
- Delivered a comprehensive report within five business days, including a prioritized corrective action plan.
Outcome:
- The client achieved supplier qualification within two weeks and avoided costly regulatory delays.
- Travel and logistics expenses were reduced by 50% compared to sending an internal audit team from Canada.
- The client onboarded a reliable API supplier, ensuring long-term cost savings on API procurement.
