Module Overview

Validation:

Overview of the documentation involved in validation. Validation Masterplan, Schedule, Product Development Report, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Validation report, The importance of specifications and limits

Process Validation:

QbD approach, Risk assessment and management, FMEA, ASTM 2500, ICH Q8, 9 and 10, CQAs, CPPs, biopharmceutical, API and solid dosage processes

Cleaning Validation:

Purpose and elements of cleaning validation, establishment of cleaning validation limits, generation of cleaning validation protocol, cleaning agents and methods.

Sterility Validation:

Methods of sterilisation, regulatory guidelines and directives, qualification requirements

Validation of GMP Critical Utilities

Regulatory requirements and guidelines, sampling plan and frequency of tests IQ, OQ and PQ requirements.

Computer Validation and Automation Validation:

Regulatory Standards and Guide lines: EU GMP Annex 11, FDA CFR 21 part 11, GAMP/lifecylce approach, documentation requirements,

Practical Course (examples)

As part of this course students will carry out a series of practicals involving the validation of a process or a GMP critical system. These will be based in the pilot plant and laboratory. This will involve generation and completion of validation documentation. the student must perfrom a qualification (IQ;OQ;PQ) of a GMP critical system and apply and interpret the data. This system could include;1. Validation of a water purification system2. Validation of a CIP system3. Validation of a pharmaceutical process4. Validation of a Biopharmaceutical process5. Validation of pharmaceutical equipment – v-blender, fermentor, tablet press, friability tester6. Validation of a Cleaning and/or sterilisation Procedure 7. Validation of on-line instrumentation – pH, pressure meters, flow meters

Module Content & Assessment
Assessment Breakdown	%
Other Assessment(s)	50
Formal Examination	50