EMA’s New 2019 Guideline on Sterilization of the Medicinal Product, Active Substance, Excipient, and Primary Container

Its Potential Impact on FDA’s Sterilization Thinking and Its Comparison to USP, PDA and Health Canada Methods

The European Medicines Agency (EMA) recently published “Sterilization of the Medicinal Product, Active Substance, Excipient, and Primary Container” in March 2019 which has an effective date of October 2019.
This new Guidance should have a dramatic impact on the FDA’s sterilization thinking since it strongly suggests that there are alternatives, i.e., Advanced Therapy Medicinal Products (ATMPs), to standard terminal sterilization standards of 121oC for 15 minutes.
This new guidance discusses the choice of selective methods of sterilization of sterile products. It also reviews the use of terminal sterilization and the importance of alternative methods for manufacturing sterile products when terminal sterilization will cause degradation. Where terminal sterilization is not possible, an alternative must be developed that includes the rationale of ICH Q9 - Quality Risk Management. For new products, the guidance provides the appropriate decision-making process within several tables for the sterilization of various final product forms, e.g., aqueous, powder, pellets. Again, Quality Risk Management and its elements are essential to the decision-making process.

This guidance will also be compared and contrasted to various current FDA, PDA, Health Canada, and USP documents to include: 1) FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (September 2004), 2) PDA Technical Report #33 Evaluation, Validation and Implementation of Alternative and Rapid Microbial Methods, 3) Health Canada “Process Validation: Moist Heat Sterilization for Pharmaceuticals”, 4) USP<1116> Microbiological Control of Aseptic Processing Environments and Its Implications (2012).

The objective of this session is to explore the use of various modes of sterilization to include new concepts that involve both aseptic filling combined with terminal sterilization, and learn how they may be used within your current manufacturing operation to provide both sterile components and final product. Please plan to attend this webinar as a team activity to get the most from this discussion.

Learning Benefits:-

• Learning of the Requirements for the manufacture of sterile medicinal products and their components
• Choices available for sterilization to include both terminal and aseptic processing sequentially
• Issues to consider when processing aqueous products
• Issues to consider when processing dry powders, non-aqueous and semi-solid products
• Risk/benefit consideration evaluation when choosing a sterilization mode
• Use of Decisions Trees to assist in the selection of the optimal sterilization method

Outline:-

• Introduction
• Review of the various modes of terminal sterilization to include steam, dry heat and ionizing
• Review of the various modes of sterile filtration and aseptic processing
• Issues to consider when processing aqueous products
• Issues to consider when processing dry powders, non-aqueous and semi-solid products
• Risk/benefit consideration evaluation when choosing a sterilization mode
• Use of Decision Trees to assist in the selection of the optimal sterilization mode
• Review of Pertinent Case Studies/Warning Letters

Who should attend:-

The following individuals or disciplines will benefit from attending this session:

• Manufacturing
• Quality
• Quality Control
• Validation
• R&D