Case Study: Audit Readiness

Opportunity…

A client in the US was concerned about the readiness for an upcoming FDA Audit of a key third party manufacturer based in China.

Approach…
  • OQSIE deployed a team of two experienced consultants, both based in China.
  • Both consultants guided the management team for the third-party manufacturer through the steps of preparing for the upcoming FDA Audit.
  • The initial step was to conduct a gap analysis of the Quality Management System and practices.
  • Our consultants guided the management team to resolve and remediate all the identified gaps.
Outcome…
  • The third-party manufacturer passed the PAI audit with flying colors.
  • Our US client successfully launched the products manufactured by the third-party manufacturer.
  • Two years later the third-party manufacturer passed a follow-up FDA Audit with no observations.

Project Examples

  1. For a global client, a small team of Subject Matter Experts (SMEs) supported the development of various part of the CMC submission documents for a new pharmaceutical product.
  2. For a medical devices manufacturer, a team of two SMEs conducted internal audits at various company manufacturing sites.
  3. For a biologics manufacturer based in the US, we conducted audits for suppliers based in Brazil.
  4. For a pharmaceutical manufacturer based in the US, we conducted audits for suppliers based in China.