subject: Submission Documentation for Sterilization Process Validation [print this page] Submission Documentation for Sterilization Process Validation
Why Should You Attend:
Having a plan for gathering and compiling appropriate sterility assurance documentation to be included in a global marketing application is essential for injectable drug products. In this session we will provide an overview of current regulatory guidance and compendial requirements associated with sterilization validation and control of microbial quality.
While guidance on overall content is readily available, a lack of understanding of specifically what information is needed and how to present it could result in regulatory questions, delay of approval, and costly repeats. This webinar will review what information is needed, what level of detail is included, and how to present the documentation in CTD format.
There are fundamental differences in the content of sterility assurance documentation for terminally sterilized drug products and those utilizing aseptic processing. In this session you will learn what data and information need to be included in your submission for these different approaches to manufacturing a sterile drug product. We will review information needed in support of the sterilization and depyrogenation of container closure components, filter validation, heat penetration and distribution studies, and container closure integrity testing.
In addition, we will discuss the need for periodic requalification of sterile processes as part of the ongoing quality program, and we will review the requirements that need to be met to gain approval for use of parametric release in lieu of sterility testing for batch release, which substantially shortens the release timeline.
Microbial quality controls are also an important component of sterility assurance. In this session, we will review relevant in process controls, validation parameters for sterility and endotoxins test methods, and acceptance criteria for the drug product specifications. We will also discuss use of container closure integrity data in lieu of sterility testing for stability studies, providing savings to the stability program.
Areas Covered in the Seminar:
Global regulatory guidance and other relevant sources for sterility assurance.
Recent changes in regulatory guidance.
Sterility assurance content for marketing applications.
Differences in content for terminal sterilization versus aseptic processes.
Expectations for requalification of sterile processes.
Use of parametric release in lieu of sterility testing at release.
Use of container closure integrity in lieu of sterility testing on stability.
Validation documentation for microbial quality test methods.
Potential pitfalls due to insufficient sterility assurance documentation.
Learning Objectives:
Knowing what data and information are needed to construct an approvable sterility assurance section for an injectable dosage form, and to understand how this information is compiled within the CMC section of a global marketing application.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Pharmaceutical development project teams
Regulatory Affairs
Quality Assurance
Analytical and formulation development
Emerging pharmaceutical companies
Instructor Profile:
Colin Davis, has over 30 years of experience in the pharmaceutical industry, primarily in regulatory affairs and project management. After completing his Bachelor of Science degree in Chemistry from Miami University, Colin joined The Upjohn Company, where he remained employed with Pharmacia and Upjohn, Pharmacia Corporation, and Pfizer, Inc. After leaving Pfizer, Inc. in 2005, he gained additional experience in the generic pharmaceutical industry working as an Associate Director of Regulatory Affairs for Hospira, Inc. and The Perrigo Co. Throughout his career Colin has held positions in analytical methods development, cGMP compliance, project management, and CMC regulatory affairs. In his position as Director of CMC Regulatory Affairs for Pfizer, Inc., Colin managed regulatory scientists in the preparation of CMC registration documentation, participated on global development teams, and spearheaded various initiatives for improving organizational performance and global quality standards.
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