How to Audit CMOs

First Impression

• Assessing the ability of a manufacturer to make your product according to your specifications

• The purpose is firstly to determine if the Pharmaceutical Quality System (PQS) is adequate and they are

operating in a state of control

• However, it is necessary to understand how their PQS works with your PQS.

• Identify any gaps and propose ways to bridge the gap.

• Special attention to Recall processes.

• This information is vital as the Quality Agreement is being developed and finalized

Courtesy of  Zena G. Kaufman