Sharing best practices between Pharma and Consumer Care
Sahil Parikh received his B.S. in Biology from the University of Connecticut. He has over 9 years’ experience in quality control microbiology, development of RMM technologies and regulatory compliance. Having transitioned from the laboratory to a commercial role as a Marketing Manager, Sahil now manages the strategic marketing for Charles River Microbial Solutions’ rapid microbial detection product line for the pharmaceutical and consumer care product industries.Here is a brief Q&A with Sahil about how different industries can help each other achieve best practices.
Rachael: How can the personal care and pharmaceutical industries close the gap and collaborate to adhere to CGMP (Current Good Manufacturing Practices) requirements and improve product release time?
Sahil: Especially during this COVID-19 pandemic closing the divide between these industries is extremely important and relevant. We are globally faced with current issues and shortages in sanitizers, wipes, cleaning products and personal protective equipment. These industries have been forced to join forces to increase and support mass production to meet the heightened demand. This crossover and dependency on each other will only continue as ongoing future scale-ups of disinfectants will be required. Wipes in general are in high demand, and manufacturers have been ramping up to meet needs faster while other companies are starting to bring wipes as “new” products into their manufacturing pipeline.
With increasing pressure for more rapid product release, we also need to be certain that all products are being tested and released as effective and safe. Maintaining knowledge and an understanding of regulatory requirements for testing of these products is crucial. For example, if wipes are marketed as a treatment or a preventative therapeutic product for ailments such as acne, diaper rash, or skin germs, then they would be considered a drug and thus required to be manufactured and tested as such (FDA.gov). Each industry has determined processes and workflows that the other has not. However, guidances and regulators will treat the manufacturing process demands and safety concerns the same. The industries can support each other by providing an understanding of quality control processes and guidelines for CGMP operations. Sharing information will support heightened demand, quality of products, and overall patient safety.
Rachael: What benefits do rapid microbiological methods (RMM) offer when it comes to data integrity and reducing human error?
Sahil: Given the nature of many required microbiology test methods being routine and repetitive, they sometimes introduce human error based on missed steps or missed test results. When routinely running the same process with the same expected test result (e.g., a negative clear plate with no colony growth), when a positive does arise, such as a very small colony, it can be missed. Knowing what a positive result looks like, and paying close attention to details could ensure a positive is not falsely reported as negative because of human element. Educating personnel on what failures may look like will allow them to familiarize themselves with results that occur less frequently.
Automated technology through rapid methods dramatically reduces and in some cases eliminates human error, manual mistakes and subjective interpretation of the results. Rapid methods also provide a reduction in laboratory transcription errors. Manually transferring data, especially a lot of different test data to one location, can be a huge burden to the analyst and laboratory process and risks introducing inaccuracies. There are numerous analyses occurring, and the results are being reported and tracked in many different locations and then transferred over to one main reporting system or software. If the result is entered incorrectly, it may appear changed and introduce questions or even an investigation. With a rapid detection systems’ automated technology, there is no chance for error, as the system is reading and reporting the result. Transcription errors are eliminated when technologies have supported electronic data platforms and robust software that can be integrated with existing laboratory information management systems (LIMS). To eliminate the above-mentioned risks, it is important to ensure you are implementing a secure, supported system that has a FDA 21-CFR Part 11 compliant software that can offer these key benefits:
- Audit trails
- Searchable data/files/record keeping
- User access controls
- Software integration
Rachael: With the increased need and benefits that RMM’s offer, how can vendors provide guidance and support for implementing new systems and validating the methods?
Sahil: It should be a partnership where vendors and manufacturers collaborate and understand their entire quality system, incorporating multiple products and samples across the whole facility. Gathering knowledge of a facility’s processes and testing needs will be beneficial for not only the vendor and customer, but for the consumer as well.
Regarding system validation and method implementation, vendors need to have the ability to provide support beyond just the purchase. The process should not be considered completed until the customer is successfully utilizing the system and generating data appropriately. The amount of information that is shared and the specifics regarding system and method validation will be different for each facility and their product testing requirements. All manufacturing facilities should have a vendor that is providing justification for implementing new rapid methods and building confidence with their customers that they are designing more accurate processes while enhancing product testing and production. This should be information that is more readily discussed in order to support closing the gaps between industries, as regulators are becoming stronger and more balanced toward holding all industries to similar requirements and expectations. Sharing information amongst peers does not infringe or take away from competitive advantage.
Vendors should always provide a commitment to their customer to see that the implementation process was a success and that the choice in an advanced system is providing processes and data that are working well for them and better than their traditional method.
Sahil's full article appeared in the American Pharmaceutical Review,
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