Earlier this month I travelled to Grapevine, Texas to attend the 32nd annual Society of Quality Assurance (SQA) Annual Meeting and Quality College. Having just started my new position as Quality Assurance Officer, literally the day before, I wanted to make the most of this learning and networking opportunity. I had been reading the GLP regulations in preparation for my new QA position, but quickly learned there is much to know that can’t be found in the little blue handbook. The following are five ‘pearls of wisdom’ I learned while attending the two day Basic Training: Good Laboratory Practice course and subsequent conference:
1. EVERY PROVISION IN THE FDA GLPs STEMS FROM LANDMARK CASES
One of the course topics I found particularly interesting was the landmark cases which lead to the development of GLP regulations. In the 1970s, FDA launched investigations into several companies responsible for conducting non-clinical laboratory safety studies which resulted in the approval of several drugs, devices, and food additives. What they discovered was astonishing by today’s standards – studies were conducted without an approved protocol or did not follow the protocol; records were incomplete, inconsistent, and fraudulent; reports were falsified and selective data omitted in order to conform to the desired outcome; the list goes on. Learning about these historical cases helped me understand the basis for current regulations and why they were established.
2. REPORTING OF SAFETY STUDIES IS STILL RELATIVELY NEW
In 1906, The Pure Food and Drugs Act was passed permitting government action if drugs proved dangerous or misbranded. However, there was no requirement for manufacturers to determine safety or efficacy before being marketed for human use. In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act after 107 people died from consuming Elixir Sulfanilamide, which contained the poisonous ingredient diethylene glycol; a substance related to antifreeze. In 1973, prior to the implementation of the FDA GLPs, the Government Accountability Office issued a report titled “Supervision over Investigational Use of Selected Drugs”. This signified the first time companies were required to run and report the results of animal studies to the FDA. It’s hard to believe such practices were in place less than 45 years ago!
3. READ THE PREAMBLES
This piece of advice was reiterated many times throughout the course and conference as the key to understanding the regulations. Preambles precede a new or revised regulation and provide important background information as to the reason for the addition/revision, the intent or interpretation of the regulation.
4. ANIMAL WELFARE: THEN AND NOW
Having a background in biomedical science, I am one of the few people at KFI without previous experience in animal health. Since starting at the company a year and a half ago, I’ve seen first-hand the importance placed on animal welfare and come to expect the highest standard of animal care. Historically, however, this was not always the case. One of the stories I found particularly shocking was the description of a rodent room at IBT Laboratories. Rats and mice would escape from their cages and breed with feral rodents living in bedding inside the animal room. Furthermore, the feral rodents would climb the cages and cannibalize the toes of study animals during the night.
Although the GLP regulations were established primarily to ensure the quality and integrity of study data, there has also been a positive impact on animal welfare. Animal facilities are now required to have adequate space to allow for separation of species, isolation of newly received animals, quarantine of diseased animals, and isolation of studies (when possible). Storage of feed and bedding must be separate from animal housing areas and protected from infestation or contamination. Cages must be cleaned at appropriate intervals and SOPs must be in place for the housing, feeding, and care of animals. By prescribing the way animal studies are conducted and setting standards for facilities, the GLPs have helped advanced animal welfare in research facilities over the last 45 years.
As the only Quality Assurance Officer at KFI, the annual SQA conference provides a great networking opportunity to share ideas, as well as discuss challenges and potential solutions with other QA professionals. Small group discussions and interactive roundtable sessions in particular fostered discussions of how to better incorporate the regulations in every day working situations.
Like many positions in research, continuing education is essential to remaining current and enhancing the quality of work we provide to our sponsors; quality assurance is no exception. Attending courses and conferences such as that provided by SQA provide valuable learning experiences and opportunities for professional development.
Kinsey Hillis BSc (Hons), MBS is the Quality Assurance Officer at Kingfisher International Inc.