This module aims to provide the student with knowledge of validation
Validation and Documentation
Validation Masterplan, ICV approach, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Process Validation, Validation report, Technology transfer protocols, stability trial protocols, shipment qualification, biosimilars
Validation of Utilities
Requirements for validation of GMP critical utilities.
Process Validation
QbD approach, risk management, ASTM 2500, ICH Q8, 9 10, Critical quality attributes, critical processing parameters, PAT
Cleaning and Sterility Validation
Elements of cleaning validation, cleaning validation limits, test methods
Computer Validation and Automation Validation
GAMP, EU GMP Annex 11, FDA CFR 21 part 11, GCP, Lifecycle approach.
Analytical method Validation
Validation of chemical, microbiological and biochemical methods used for testing raw material and finished product in line with ICH guidelines.
Medical Devices
regulatory requirements in the medical device industry.
Equipment validation
Regulatory requirements and guidelines for the validation of equipment used to manufacture and test medicines
Technology Transfer
regulatory, guidelines, studies and documentation requirements for the transfer of manufacturing processes and analytical methods
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 30 |
| Formal Examination | 70 |