Schools Training

What to Expect When Your Pharmaceutical Quality Control Lab is Audited

24 JUL 2012
Career Path : Quality Control

Your HPLC courses will prepare your to work in a lab, where you may be subjected to the occasional government inspection. Here’s what a pharmaceutical quality assurance inspection may entail.

A government inspection team may observe your pharmaceutical quality control lab in operation.  But what kind of things will inspectors be looking at?



As you no doubt learned in your HPLC courses over the years, good recordkeeping is an important part of laboratory work. As such, your recordkeeping practices may be subject to inspection from time to time.

N.B. The records communally kept by all analysts working in your lab will be subject to inspection, but inspection teams may also ask to see your personal documentation. These personal records may be compared against official records. Government pharmaceutical quality control lab inspectors may need to cross-reference documents.


Raw data

Over the course of your pharmaceutical quality assurance career, you will handle a lot of raw data. A complete inspection includes an evaluation of the data that you use. It is one way for an external inspector to determine whether or not you are adhering to the required regulations for pharmaceutical quality control.

To facilitate auditing of your raw data, be sure to observe proper procedure, e.g., maintain it in one bound document, clearly marked “data: pharmaceutical quality assurance.” Any loose sheets of paper or missing information could raise red flags. Get into the habit, as you probably learned in your HPLC courses, of including written explanations anytime information is missing or lost.



You can reasonably expect your methodology to be subject to repeat inspections over the course of a normal career in a lab. Inspectors will want to observe and assess your procedures and the way you calibrate your equipment. It may remind you of the tests your professors submitted you to way back when you were still taking HPLC courses.

N.B. Be prepared to justify why your pharmaceutical quality control lab has chosen to prioritize one method over another, where more than one accepted method exists.



Inspectors who examine pharmaceutical quality control labs will have the knowledge set to assess chromatograms, etc., for any sign of analyst error.


Special attention to past failures

As you were taught in HPLC courses, you must record any test failures in your records. Government inspectors may ask you to show such listings in your records, so that they can see how failed tests were handled.  Were they handled in a timely manner? Was proper procedure observed? How many batches were affected? Was the exact nature of the mistake identified and rectified?

If you maintain your lab by adhering to the techniques taught in your HPLC courses, you should soon develop a sense of confidence and ease surrounding government inspections.



Visit AAPS for more information on pharmaceutical quality assurance.