Microbiology Core Competencies and Control in the Facility
Enhance microbiology accuracy, efficiency, and product quality through partnerships. A Q&A with expert Don English
Industrial microbiologist and consultant Don English frequently encounters facilities that attempt to cut corners to save money. Unfortunately, this also jeopardizes the quality of their product and increases risks to patient safety, which in turn costs companies money.
With more than 40 years of experience at the bench and managerial levels in industrial microbiology, Don is an industry veteran. He has worked in the R&D and QC Micro lab at Avon Products, Inc., GlaxoSmithKline Consumer Healthcare, and Merck and Co. He graduated summa cum laude from the University of Charleston with a Bachelor of Science in Biology and has a Master of Science from North Carolina State University in Microbiology with a minor in Biochemistry. He currently provides consulting services to the cosmetic/personal care, dietary supplement and pharmaceutical industries.
Senior Technical Writer Rachael Kerr, with Charles River's Microbial Solutions division, recently had the chance to speak directly with Don regarding reoccurring concerns and questions pertaining to laboratory cost of equipment, consumables and analyst time when performing required microbiology tests.Here is a edited version of that discussion.
Rachael: There are frequently asked questions regarding microbiology and quality control processes related to cost and efficiency. With strict guidance and regulatory testing requirements, we know cutting corners is never the answer. Many people look for your suggestions on ways to reduce their microbial testing cost. What suggestions do you offer?
Don: Correct, cutting corners to save money when it comes to required testing will only increase process error and increase the risk of having faulty testing and release of unsafe products. Areas that I suggest saving costs on are with the purchase of disposables and consumables required for conducting laboratory testing. In addition, laboratory personnel must have an understanding of their processes and what types of supplies are routinely needed and be certain that they are ordering the appropriate items. Never deviate from the testing process to save time and money. Regarding efficiency and time, rapid microbial test methods should be a consideration to enhance and improve laboratory processes.
Outsourcing some of the required analysis, such as microbial identifications of recovered isolates, and partnering with a company that has trained microbiologists and professionals, will spare your laboratory time and money if it is not equipped properly to conduct microbial identifications on its own.
Rachael: You often discuss vendor / supplier partnership in Current Good Manufacturing Practices (CGMP) for microbial testing. How does this relate to a partnership where specific expertise are required for microbial identifications?
Don: A successful microbiology laboratory must have an understanding of the microflora that is present in a facility. This requires an experienced and educated microbiologist to be on site. If the site does not have an experienced microbiologist, they should not be performing identifications. Lacking in-house experience will cause inaccurate microbial identifications of recovered isolates. Very few companies maintain experienced, qualified personnel to handle the identifications of these organisms and understand the proper process in how to identify an organism.
I have heard some contract testing laboratories will take 2-3 weeks to yield an identification result for an isolate. However, it’s important to partner with a reputable and dependable contract lab that maintains trained, qualified professionals and offers turnaround time options and much faster delivery on accurate identification results to the genus/species level for all recovered isolates.
Rachael: The Food and Drug Administration (FDA) has found that over 30% of the worldwide audits had noncompliance issues.. In addition, in the US alone, over 4,500 drugs and medical devices are recalled and removed from market each year. How can companies avoid becoming a part of this statistic?
Don: There seems to be a lack of training and experience. Methods and processes are being implemented without a full understanding of what they are actually doing, why they are testing, and the value of each analysis. Facilities need to be able to depend on the analyst to follow procedures as written, with no deviations, and have an understanding of the science behind the test method and as well as good analytical technique when testing. Laboratories must maintain accurate and sound processes, be able to recover organisms, understand what the organism is and why it is present, know how to handle the organism, track an accurate identification, and control or mitigate the organism to avoid product contamination.
Keeping compliant processes results in data, it is imperative to properly manage that data. Data integrity indicates the presence of accurate test results and provides proof of effective processes. Many warning letters and 483’s are issued due to the lack of proven data integrity.
Rachael: When discussing a state of control in a microbiology environment and the ability to minimize risk of contamination, what are the important core competencies that the facility must possess?
Don: One main competency is having trained personnel and an experienced microbiologist in a facility. There is necessary education and training that comes along with understanding Microbiology and the science behind the testing required in a cGMP microbiology lab. Many believe the only objectionable organisms are those that are listed in USP Chapter 1111, and that if a microbial species is not listed, it is not objectionable for a finished product formulation. This is inaccurate, in fact, most product recalls are due to organisms that are not included in USP Chapter 1111. In addition to required testing, expertise is required to set appropriate microbial test specifications for raw materials and finished products. Some companies that may run into issues maintaining state of control fall short in understanding how to set these appropriate specifications, which then results in inaccurate test data.
Charles River offers microbial identification services for medical device, personal care and cosmetics, and pharmaceutical product manufacturing facilities using both MALDI-TOF and DNA sequencing technologies which contain a critical diversity of organisms. Learn more about partnering with Charles River Laboratories to enhance your Microbiology processes and testing.