Overview of ICH Guidance’s enhanced pharmaceutical development. Covering all Q guidance’s with reference to FDA, EMA and other regulatory considerations
Overview of the stages of process validation (Process Design, Process Qualification and Continued Process Validation)
Quality target product profile and Critical Quality Attribute identification
Analytical target profile, analytical method control strategy and importance of comparability studies
Process characterization studies, risk assessments (Failure mode and effects evaluation) and identification of critical process parameters
Process control strategy and demonstration of a process state of control
Process Performance Qualification (PPQ)
Continued Process Verification (CPV)
Equipment Qualification
Regulatory Readiness and Response

Overview of regulatory expectations for sterile products with particular focus on Annex 1, FDA, and SFDA guidelines
Importance of a contamination control strategy with special consideration for ATMPS with no terminal sterilization possible
Terminally Sterilized Drug Products
Aseptically Filled Drug Products
Consideration for ATMPS with no terminal sterilization possible: validation of process and utilization of contamination control strategy
Considerations due to methods of aseptic equipment preparation.
Considerations related to specific drug delivery methods, Lyophilisation, prefilled syringes and others
Linking to the overarching process (drug substance / products) and product control strategies, integrating