Entries by Regula Inspection Services

FDA Inspection Readiness

FDA investigators are knocking at your door—are you ready? Your first thoughts may be of logistics— meeting space, document availability, the condition of your facility—but what about personnel? Are your employees prepared to face FDA investigators who are trained to thoroughly investigate a manufacturer’s entire operation?

How to Ask The Right Question During a GMP Audit?

Asking the right question begins in the preparation phase of the GMP Audit. An understanding of the requirements, the SOPs, work instructions and forms play a major role in asking the right questions. Use this information to generate a checklist that is meaningful. Before the GMP Audit, you should know what you are going to […]

Let’s Prepare for A GMP Internal Audit – Part I

Be prepared A GMP Internal Audit’s success often hinges on preparation. Generally, an extensive GMP Internal Audit requires considerable preparation to identify opportunities for mutual gain. Before a GMP Internal Audit begins, you should make sure that you know the procedures better than the supervisor of the department being Audited.

FDA Inspection of HPLC – Part I

The US health authority Food and Drug Administration (FDA) carries out domestic and foreign inspections to investigate whether an organization works in accordance with the US law (Code of Federal Regulations, CFR) and international guidelines. For the production and control of classically and biotechnologically manufactured pharmaceuticals, the American laws Current Good Manufacturing Practices in Manufacturing, […]

How to Select GMP Internal Audit Team?

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.