Best Practices in Validating Methods for Use in Pharmaceutical Product Testing
Method development and validation typically focuses on analytical chemistry techniques and microbiological testing development and validation can be secondary considerations. However, the risks of inappropriate microbiological testing and poor validation can bring delays and financial impact. It is absolutely vital to ensure compliance with current regulatory safety standards by utilising properly validated methods for the microbiological testing of all pharmaceutical products. This can be a difficult process depending on the type of product in question, however, it must provide evidence that the testing process will produce reliably consistent results. The test methods used must be suitable for purpose and must be supported by sufficient relevant data to confirm the method's suitability.
In addition, this webinar will include other non-analytical testing procedures and our speakers will discuss the general requirements of method development as well as unique challenges facing the validation of various complicated processes such as the testing of cytotoxic substances, sterility testing and in vitro methods. Discussion points will include method suitability assessment, method transfers, validation of alternative methods and compendial method validation.
We will also discuss the study aspects which must be considered in the development of any validation protocol intended for regulatory submission, including those such as specificity, linearity, range, limit of detection and quantification, accuracy and precision of the microbiological or in vitro method being developed.
While method validation can be time consuming and complicated, it is important to remember that validation is performed to establish that the performance characteristics of a test method meet the requirements for the intended application and are robust enough to hold up to regulatory scrutiny. This is a valid concern for anyone involved in the design, testing or manufacture of pharmaceutical products and we invite you to join our speakers as they discuss challenges and best practices in method development.
Lynne Murdoch, BSc (hons), PhD, CBiol, MRSB,
Business Manager - Microbiology
Dr. Murdoch joined Wickham Laboratories Ltd in 2014 as part of a strategic initiative to push forward research and development projects within the company. In 2016, she transitioned from R&D Operations to a new role as the Business Manager in microbiology, providing strategic oversight and leadership of the department. She received her degree in Microbiology and Immunology from the University of Strathclyde in 2007 and subsequently pursued a PhD in Microbiology/Electronic and Electrical Engineering.
Joanna Greenhough, MSc, PhD, MRSB,
Research and Development Scientist
Dr. Greenhough joined Wickham Laboratories Ltd in 2015 as a Research and Development Scientist. In this role, she is responsible for the transfer of new methods and technologies to the routine testing laboratories through research and development including method validation in accordance with appropriate regulatory guidelines within the cGMP environment. She holds a PhD in Biomedical Sciences from the University of Southampton and had previously worked as part of a research team at the Faculty of Medicine.