Validation of Microbiological Test Methods

Introduction

Validation of microbiological test methods is gaining interest in today’s environment, with the issuance of PDA Technical Report No. 33, “Evaluation, Validation and Implementation of New Microbiological Testing Methods”, USP <1223> “Validation of Alternative Microbiological Methods”, and “AOAC INTERNATIONAL Qualitative and Quantitative Microbiology Guidelines for Methods Validation”, as well as the continuous evolution of rapid microbiological methods.

With the FDA most willing to participate in more rapid microbiological in-process and final product releases and the opportunity to obtain results in hours, rather than days, a litany of companies are developing their versions of rapid microbiological methods.  The questions for each of us are what is most applicable to both our in-house and regulatory requirements and are they cost effective. To perform these analyses, we need to examine the DQ/IQ/OQ/PQ of these various instruments as well as microbiological method validation.

The objective of this live and interactive BenAstrum web training course is to explore the validation of microbiological test methods and the efforts required to satisfactorily meet their validation requirements.

Discussion Points:

• Characteristics of traditional and contemporary methods
• New technology for microbiological testing
• Initial considerations required to meet the microbiological plan design
• Establishing analytical procedures based on process/product requirements
• Developing acceptance limits for products, components and processes
• Elements of a microbiological validation
• Review of validation criteria and recommendations for satisfying each as part of a microbiological validation
• Validation plan design

Learning Benefits

• Understanding the regulatory expectations for validation of microbiological methods
• Utilizing the application of TR No. 33 and USP <1223> to the validation of microbiological methods
• Validation of microbiological methods
• Recognition that methods developed for one product type do not always perform as intended for another product type
• Improving process reliability
• Improving product safety and reliability

Who Can Benefit:

Those who will benefit from this course include Quality Assurance, Quality Control and Validation professionals who are contemplating microbiological validations as well as those already involved in these validations.  Personnel involved in the technology transfer of early stage products will also benefit through forward thinking regarding the microbiological validation requirements to expedite the release of product during Phase 3 and following commercialization.

Please click here for the course agenda