Purdue University Biotechnology Innovation and Regulatory Science (BIRS) Program ABE 51200 Good Regulatory Practices Course Offered: Spring semesters

By: Dr. Stephen R. Byrn, a Charles B. Jordan Professor of Medicinal Chemistry in the College of Pharmacy; Dr. Kari Clase, a Professor in the Department of Agricultural and Biological Engineering, College of Agriculture; Purdue University, West Lafayette, Indiana.

The Purdue BIRS center GRP (good regulatory practice) courses were developed almost 20 years ago with input from AbbVie, Lilly, and Dr. Mike Schmidt. Good regulatory practices is a general term intended to cover GXP areas - good manufacturing practices (GMP), good laboratory practices (GLP), and good clinical practices (GCP). Good manufacturing practices address areas involving the synthesis of the active pharmaceutical ingredient (drug substance), the development of the drug's dosage form, and areas related to drug quality and quality by design. Good laboratory practices involve preclinical studies using cells or animals, and good clinical practices involve acceptable procedures for clinical trials. Since the original development of the good regulatory practices course, ICH (International Committee on Harmonization) has published numerous guidelines related to GxP.  These define international GRP regulatory areas.  Additionally, there has been a substantial focus on risk evaluation in all three areas. Accelerating development while maintaining quality GMP, GLP, and GCP has become increasingly important, especially with the appearance of Covid and other potential pandemics. Warning, letters, and failed inspections continue, emphasizing GMP, GLP, and GCP for regulatory professionals. Good regulatory practices also include good review practices and the best procedures for reviewing submissions. 

Good Regulatory Practices – A Brief History

It is important to realize that the term "current" applies to all areas of good regulatory practices (GMP, GLP, and GCP). This means that current practices are emphasized, not just the original law. Thus, as science advances, current practices are incorporated into GRP. For example, the GMP law was originally passed in 1978. There's been no revision of this law, but rather current practices have revised the original concepts. This usually happens by the application of newer concepts during an FDA review or an inspection. In some cases, companies have disagreed with the application of new practices and filed lawsuits contesting the conclusions of the FDA. However, in almost every case, the courts have sided with the FDA that implementing "current" good manufacturing was allowed. In addition, the original 1978 GMP law covered eight systems; later, six systems were introduced by the FDA. These six systems combine two of the eight into six simpler systems. The six systems include quality, production, laboratory, materials, facilities, and packaging. Also good documentation practices are required for all three areas of GRP (GMP, GLP, and GCP). These practices focus on the best way to document studies. Another area of importance is good distribution practices (GDP), especially since some of the new vaccines required cold distribution at -80°. Finally, CAPA and change control are critical to GRP.

GLP is good laboratory practices and involves regulation surrounding animal experimentation and toxicology studies. Although the FDA recently issued a guidance stating that animal studies are not required for all NDA (New Drug Application) approvals. NDAs in many cases, will still require some animal studies to assure drug safety.

In the 1970s, there were many serious violations relating to the care of animals used for toxicology studies. These were discussed in the US Senate and throughout the pharmaceutical community, and stronger regulations were implemented.   The Study Director is critically important in good laboratory practices (GLP) and oversees all procedures. Additionally, analytical laboratories for good laboratory practices were established and are covered in the GLP regulations. GLP laboratories measure blood levels, metabolism, and toxicokinetics of drugs in animals. Understanding metabolism and toxicokinetics in animal systems is critical to ensuring safety for subsequent human studies.  In recent years there has been an emphasis on utilizing cellular studies to replace research using live animals.

Good clinical practice (GCP) has been required for many years. As was the case for animal studies, these regulations were introduced to correct serious ethical deviations. Deviations in GCP date back to the studies of Jenner who tested the first smallpox vaccine on his gardener's son. Good Clinical Practices have been implemented to try to avoid these improper activities. For example, an institutional review board (IRB) must now approve clinical trials. Extensive clinical trial monitoring is also required.

Are You Ready to Expand Your Regulatory Toolbox?

Finally, all of the information generated from the manufacturing, the preclinical studies, and the clinical trials is combined into the NDA. All of this information is absolutely critical for a successful NDA and critical to accelerate the development of drugs. As with the Drug Discovery and Development Course, the Good Regulatory Practice course provides learners with an overview comparable to that obtained by rotating through the CMC, GLP, and GCP areas but in a much shorter time.

The BIRS ABE 51200 Good Regulatory Practices course provides a strong overview of these areas and enables students to rapidly understand GRP issues in the workplace.

Additional Information

If you are interested in enrolling in this course or learning more about the BIRS/BQRC programs, contact Mary Speer at mspeer@purdue.edu.