Schools Training

One Secret to Success After HPLC Courses: Good Recordkeeping!

31 JUL 2012
Career Path : Quality Control

As you will have no doubt been told time and time again in your high-performance liquid chromatography (HPLC) courses, you may, over the course of your career, be subject to frequent inspections, both in-house and external. Looking for a way to make sure that these inspections go as smoothly as possible? Maintain good records.  Good records are key to pharmaceutical quality control.

 

What kind of documentation might inspectors want to see?

The short answer: Everything, including worksheets, laboratory notebooks, etc. A pharmaceutical quality control inspection can involve a thorough inspection of all records made in a lab, whether communally, as a team, or individually, as an analyst.

Pharmaceutical quality control inspectors are trained to cross-reference all documentation – purity tests, charts, etc. – looking for discrepancies. This is one reason why your professors in HPLC courses will have been so insistent on the importance of taking careful records at all stages in the pharmaceutical quality control and pharmaceutical quality assurance process.

 

What kind of information will inspectors be looking for in your documentation?

Pharmaceutical quality control inspectors will pay careful attention to all dates. They will want to make sure that tests were carried out within the proper sequence, as taught in HPLC courses.

 

What will raise red flags?

Loose-leaf sheets will invite further scrutiny from pharmaceutical quality control inspectors, most of whom will expect to find your documentation bound, as you may have learned to prepare your documentation in your HPLC courses.

Any gaps will raise eyebrows as well. If you are missing any information, you must make a written note of the circumstances. This will serve you well if you are subjected to a pharmaceutical quality assurance audit.  A good rule of thumb, as sometimes taught in HPLC courses, is to include everything. There is no need to be selective when it comes to this type of recordkeeping. More is definitely better.

Use correction fluid sparingly. White-outs and cross-outs can invite the wrath of pharmaceutical quality assurance inspectors. (Perhaps they merited the same reaction from the teachers of your HPLC courses.)

If you do make changes to information, you must do so with written explanation. Any unjustified changes could draw negative attention from pharmaceutical quality control inspectors.

 

In any case, good recordkeeping helps prevent mistakes

Good recordkeeping is more than just a question of breezing through the next audit of your pharmaceutical quality control laboratory. Keeping records of your practices will also help you improve them. It pays to keep the same experimental eye with which you may have first approached your HPLC courses.

Ultimately, pharmaceutical quality control is not just about calibrating and chromatography. In some ways, it is simpler than all that. It is about paying careful attention; about making careful choices and knowing why; and about taking responsibility for fixing any errors as they occasionally arise.

 

 

Visit AAPS for more information on pharmaceutical quality assurance.