Risks, Regulations and Determining the Best Method for Your Product
Determination of microbial quality is something which every pharmaceutical manufacturer must consider in the development life cycle. Depending on the product in question, the methods utilised for microbial limits testing can vary broadly and it is important to understand in advance what is the best suited method for your individual product. Crucial to the decision on which method is suitable is to have familiarity with both the regulatory guidelines and awareness of how the available methods work with specific product types.
In this webinar, we will first review the general pharmacopoeial guidelines involved in the Microbial Examination of Non-Sterile Products, including the harmonisation of these methods across global regulatory bodies. There will be an additional focus on indicator organisms and determining which organisms are objectionable as well as risk assessments and their place in the testing process.
Our speakers will then discuss the various microbial limits testing methods in detail with a pros and cons approach to best practices in determining the appropriate method for specific products. They will also provide an experience based assessment of the roadblocks certain product types might pose in this testing process such as product sensitivity and sample extraction including guidance on how to deal with samples which cannot be neutralised.
As a crucial part of the regulatory guidelines for any product development, your requirements for microbial limits testing must be assessed from a well-informed basis. We invite you to join us for this webinar as we explore the challenges inherent in determining method suitability for microbial quality assessment.
Presented by
Laura Bailey BSc,
Laboratory Manager
Laura Bailey joined Wickham Laboratories Ltd in 2007 as a Technician in the Pharmaceutical Microbiology department. She became Head of the Quality Control section in 2011, subsequently being promoted to a Microbiology Laboratory Manager in 2014 due to her expertise in quality control testing and validation methodology. Her degree was received from Portsmouth University in 2012 in the area of Biomedical Science.
Letitia Chisenga BSc MRSB,
Section Head – Quality Control
Letitia Chisenga joined Wickham Laboratories Ltd in 2008 as a Technician in the Pharmaceutical Microbiology department. In 2014, she advanced to Section Head for Quality Control, specialising in the testing of non-sterile pharmaceuticals. Her degree was received from Portsmouth University in 2013 in the area of Biomedical Science.
