Understanding the Pharmaceutical Quality Control Inspection Process
Career Path : Quality Control
As a future graduate of HPLC courses you may feel a mixture of excitement and fear at the prospect of one day embarking on a career in a pharmaceutical lab. Excitement about finally being qualified to follow your chosen career path, fear at the prospect of being responsible for the proper operations of a pharmaceutical lab, of passing muster at quality control inspections. It may ease your troubled mind to learn more about the inspection process. It isnât scary at all. In fact, it should remind you a lot of the inspections to which you are already submitted in the labs at your school. After all, as someone who was attracted to this kind of pharmaceutical laboratory work, you are probably by nature detail oriented, organized and conscientious.
When undergoing an inspection of your pharmaceutical quality control lab, you may be asked to provide a chart of all personnel, which includes their duties, challenges and qualifications, e.g., HPLC courses and other training.
You may also need to establish to your pharmaceutical quality control inspection team that there is a good system in place to train new recruits and to evaluate existing employees for proficiency. Inspectors may also want to ascertain that access to your laboratory and records is restricted to qualified personnel.
Your Internal Pharmaceutical Quality Control System
What international standard does your pharmaceutical quality assurance lab adhere to? Who is responsible for ensuring quality? What procedures are in place to review performance and to make changes?
Does your pharmaceutical quality assurance lab have the proper equipment? Is it suitably calibrated? Well maintained?
As you will have learned in your HPLC courses, a pharmaceutical quality control laboratory team must be conscientious about its documentation. The following records must be well organized and easy to access at all times:
-Â Â Â Â Â Â Â Â Â raw data
-Â Â Â Â Â Â Â Â Â derived data
-Â Â Â Â Â Â Â Â Â sample logs
-Â Â Â Â Â Â Â Â Â calibration records
-Â Â Â Â Â Â Â Â Â validation records
-Â Â Â Â Â Â Â Â Â verification records
-Â Â Â Â Â Â Â Â Â analytical worksheets
-Â Â Â Â Â Â Â Â Â final results
-Â Â Â Â Â Â Â Â Â procedures
-Â Â Â Â Â Â Â Â Â SOPs
An external pharmaceutical quality control team will take particular attention to how your organization has handled its own internal audits in the past. What corrections were proposed? Did the laboratory follow through on them?
Here, the inspection team will be looking to make sure that your pharmaceutical quality control lab is of sufficient size and that there are dedicated spaces for each discrete activity â a principle no doubt hammered into you by the professors in your HPLC courses.
As you may have already noticed, surviving an inspection is mainly a question of adhering to the best practices taught to you in your HPLC courses and other training. Treat every day in your pharmaceutical quality control laboratory as though it is a potential inspection day, and you are sure to do well.
Visit AAPS for more information on pharmaceutical quality control.