The Standard Operating Procedures (SOPs) have a detailed description level. It has been said that they should be written so that you could take any person from the street and that person would be able do the correct thing by following the SOP. Read more
If you were the chief executive officer of a successful pharmaceutical company would you want to know that your company was meeting and exceeding customer expectations? Do you know who your customers are? Read more
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? Read more
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 ask and what evidence you will be looking for. Read more
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.
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, Processing, Packaging or Holding of Drugs: General and 21 CFR Part 211 cGMP Current Good Manufacturing Practices For Finished Pharmaceuticals constitute the essential legal framework for manufacturers and test laboratories. Read more
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. Read more
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.
We’ve often said that GMP Internal Auditing is a sampling. We don’t Audit everything, only bits and pieces. The question that is often asked, is what size should those pieces be? How many records should we examine? How many people do we ask a particular question to? How long do we observe a particular action?
All of these questions center around selecting the appropriate sample size for GMP Internal Auditing purposes.
A Pharmaceutical Quality Management System should do more than just ensure only quality products go out the door. It should also be a vehicle for continuous improvement. In today’s economy, any organization that does not continually improve, is rapidly dying. Even we are not immune. So what does this mean for the Internal GMP Auditor? We are (or at least should be) at the forefront of the continuous improvement methodology.