What challenges do pharmaceutical manufacturing laboratories experience with their quality control testing?
Pharmaceutical laboratories ultimately want to make sure their products are safe. They need to ensure the quality of the media they are using for testing, monitor laboratory equipment and obtain good samples. Making sure personnel are properly trained, and maintaining microbiological strains carefully is a constant challenge. Of particular concern is the accuracy of the quality control tests required by the USP such as growth promotion testing, method suitability, and antimicrobial effectiveness testing. Our Technical Support team assists laboratories by guiding them through testing requirements, acceptance criteria and best practices. For example, one common topic I am asked is understanding the criteria for new medium to be accepted for use in tests for specified microorganisms. We will reference the criteria of the USP <62>, Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms; that the number of colonies on the new agar must be comparable to the number of colonies on the previously approved agar. It is not necessary to be within a factor of two, and that it is necessary for colonies on the new medium be comparable in appearance and indicative reactions to colonies on the previously approved medium.
As a supplier of quality controls to pharma manufacturers, how do you help pharmaceutical companies and laboratory professionals assure the accuracy of their test results?
Microbiologics enumerated products are designed specifically for the pharmaceutical laboratories testing requirements, they are easy-to-use and in the appropriate CFU count. They require only refrigerated storage and are traceable to reference culture. We offer the compendial strains, plus many others needed by the pharmaceutical manufacturers. If the pharmaceutical laboratory needs to QC test with an environmental isolate, or a strain not in our product line, they may contact our Custom Solutions team and we will provide it in a ready-to-use format. https://www.microbiologics.com/custom-solutions
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Our Technical Support team is here to help pharmaceutical laboratories better understand testing requirements of the USP and other standards. Our specialty is that we are available on the telephone, you can speak with us personally, or email us if that is better for you. We will answer questions and walk through any challenges you are having. Our online Support Hub at https://www.microbiologics.com/ provides key documents such as instructions for use, illustrated instructions, online Certificate of Analysis, and safety data sheets. We have a video on how to use our EZ-Accu Shot for Growth Promotion Testing and our EZ-PEC for Antimicrobial Effectiveness Testing, and a variety of technical publications, Growth Promotion Test Guides, and Frequently Asked Questions (FAQs).
Looking ahead, how will Microbiologics continue to meet the needs of its current and future customers in terms of providing controls?
At Microbiologics, we embody a culture of innovation to continuously improve our quality, processes and products. We monitor the needs of pharmaceutical laboratories, new technologies, and stay current on requirements of the USP, and other international pharmacopoeias. Our team of experts make sure that high-quality controls are available for the required tests, adding microbial strains as needed. If you can’t find what you are looking for on our website, reach out to the Technical Support team and we can guide you to a best fit product or connect you with the correct departments for creation of a custom product.
How are you assisting laboratories with compliance to the new USP <60>?
Effective December 1st, 2019, the USP added <60> MICROBIAL EXAMINATION OF NONSTERILE PRODUCTS-TESTS FOR BURKHOLDERIA CEPACIA COMPLEX. In the near future, Microbiologics will have all three of the required Burkholderia strains available in both our EZAccu Shot and our Epower formats so our customers have the strains they need to complete their Growth Promotion and Suitability Testing requirements. It is important to note that all three of the strains are required by <60>: Burkholderia cepacia, Burkholderia cenocepacia, and Burkholderia multivorans. The original published version of USP <60> stated an “or” in the table of microorganisms and it has been brought to our attention that this is an error and will be corrected in a revision to clarify that all strains are required for growth promotion of Burkholderia Cepacia Selective Agar.
About Kali Sorum
Kali Sorum has been a part of the Technical Support Team at Microbiologics since 2012. During her time in the role, she has provided technical support to Microbiologics’ customers internationally and domestically for our products used as Quality Control reference materials in various industries such as the Pharmaceutical, Food, Cosmetic and Clinical. She addresses how they are used and implemented in Quality Control testing for multiple regulations including but not limited to the USP, BAM, CLSI, FDA, and others. Other duties include investigation of product complaints, planning and executing laboratory investigations, assisting and developing training programs on the use of our products and specific test methods, as well as supervision of the Technical Support Team. Kali has also been a part of the Internal Audit Team since 2014. Auditing yearly to FDA Part 820, ISO 17025, ISO 13485 and ISO Guide 34 standards. She has a Bachelor of Science degree from Nebraska Wesleyan University in Biology and Pre-Pharmacy as well as a minor in Chemistry. She has been certified as a Registered Microbiologist in Pharmaceutical and Medical Device Microbiology (RM) through the National Registry of Certified Microbiologists (NCRCM) since June of 2016.