Agilent Offers Compact Primer on GLP and cGMP for Analytical Labs

"The challenge is to find a good compromise between not doing enough and doing too much. Let's take validation as an example. When complying right at the beginning of the validation process the additional value to each validation step is tremendous." – Ludwig Huber, Agilent

Perhaps the greatest shock to new pharmaceutical lab or production workers is the realization that three letters of the alphabet have changed their lives forever. I'm talking about GLP for lab workers and GMP for those in manufacturing. I'll never forget the shock of learning from my first boss that our company, and an agency no less important than the U.S. Food and Drug Administration, expected me to carry out my job in what to me seemed to be ritualistic, almost fetish-like, fashion. Since our group performed both R&D and manufacturing, we were, at various times, operating under either GLP (Good Laboratory Practices) or GMP (Good Manufacturing Practices).

All the horrible "skills" I'd mastered in grad school—like post-dating notebooks, not signing anything, smoking and eating in the lab (sometimes simultaneously)—went out the window during my first month or so on the job.

To say my initiation to GLP and GMP was haphazard would be an understatement. I picked up bits and pieces as I went along from my supervisor and coworkers. Don't get me wrong—plenty of good training materials existed back in 1987, mostly in the form of loose-leaf bound manuals. But who had the time or the inclination to read them?
GLP/GMP training has come a long way since then. Today's pharmaceutical professional has access to videos, CD-ROMs, and online training as well as more portable print publications on how to comply with regulations.

Agilent Technologies' (Palo Alto, CA) new primer on GLP/GMP for regulated analytical environments (pharmaceutical and chemical QA/QC laboratories) will help any analytical chemist get up to speed on regs that affect his/her job. Pharmaceutical professionals in discovery, scaleup, and manufacturing will especially appreciate this book.

The 116-page primer provides in-depth explanations of GLP and GMP, discusses the requirements for following these critical regulations, and provides a gentle review of Agilent's offerings as a leading instrument and service provider for regulated analytical industries.

Scientists and engineers learning GLP/GMP appreciate to-the-point manuals like this one. On the other hand, it's important to explain why a regulation exists and how not to fall prey to laboratory compulsions. For example, there is no added value in validating each and every step in each and every laboratory operation, since incremental costs for validation go up with each validation effort. "Where is the optimum, and how much validation is enough?" asks Ludwig Huber, who manages Agilent's worldwide marketing for its liquid chromatography products. "The challenge is to find the optimum and this requires a thorough risk analysis. With the help of this primer and listed references the reader will get enough guideline to find this optimum for his or her specific process."

For more information: Lois Replenski, Agilent Technologies, 71 Southgate Blvd., 3830, New Castle, DE 19720. Tel: 800-227-9770.

By Angelo DePalma