EMA New 2019 Guideline on Sterilization of Medicinal Products, Api, Excipient and 1º Container
: 5 Sep 2019
Sector: Clinical, Pharmaceutical, Veterinary, Water
Type: Training, Webinar
The European Medicines Agency (EMA) recently published “Sterilization of the Medicinal Product, Active Substance, Excipient and Primary Container” which has an effective date of October 2019.
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.
The objective of this live and interactive training webinar is to explore the use of various modes of sterilization and learn how they may be used within your current manufacturing operation to provide both sterile components and final product.
This guidance will also be compared and contrasted to various current FDA, PDA, Health Canada and USP documents