Multiple Site GMP Audits – Part I

When we think of GMP Internal Auditing, we tend to think of Auditing a single building. Most Pharmaceutical Companies are single-site facilities, although many have several buildings, they are still really single sites. Typically, the GMP Auditors know the auditees, the processes and activities that are being Audited. Objective Auditing can be difficult.

Multi-site GMP Auditing is usually far different. Many of the internal rules that you apply to regular GMP Internal Auditing are not applicable with multi-site GMP Internal Auditing. It is common for the GMP Auditors to have little contact with the auditees prior to the GMP Audit. Many of the processes and activities are new to the GMP Auditors and they may have limited exposure to Audited site. In some cases, the site might be in another city, or even country. Because of this, GMP Auditing multiple sites might be closer to 2nd, or 3rd party Auditing. In every case, the GMP Internal Audit contains the same three major components:

  • Audit Preparation
  • Audit Conduct
  • Audit Reporting

Let’s look at each of these and see what an GMP Internal Auditor needs to do in order to have a successful and effective GMP Internal Audit of multiple site.

Audit Preparation:

Every GMP Audit needs adequate preparation in order to be successful. The GMP Auditor must be familiar with the Audit criteria (GMP Directives and Guidelines, the Organizational / Corporate documentation and any other requirements that will be used to determine conformance), GMP Auditing methodologies (interviewing, observation and examination), and of course the processes of the activity being Audited. When Auditing multiple sites, you need to be familiar with the documentation and records of the site you are Auditing. Many companies have variations in documents from one site to another.  Maintaining a separate file for each site could be a great help remembering which site has which documentation.

…To Be Continued