Unfortunately there is no perfect number of GMP Auditors a Pharmaceutical & Biotechnology company must have to perform effective GMP Internal Audits. Some companies, particularly those in the Aerospace, Nuclear and Automotive Industries, are fortunate enough to have full time Internal Auditors.
Most, however, call on employees who are already fully utilized in other roles.
The number of GMP Internal Auditors you must train will depend on several factors;
- The size of your organization
- The type of product produced
- How you define the scope of each audit
About the only incorrect answer would be to train a Single Auditor. Then, who will Audit the GMP Internal Audit Process? Who will Audit the other activities performed by the Auditor? Unless your organization plans to outsource some or all of the GMP Internal Audit process, you will need to train at least two Auditors. Other than that, a general rule of thumb is to have enough qualified Auditors in your Auditor pool to ensure that any one Auditor is not called on to perform more than one Audit each quarter.