Module 3 Presentations

07/05/2024

GMP Challenges for Clinical Trials Manufacturing

Batch Scale/ Size

Products

Packing

Manufacturing

Absence Validation

QC

Premises

Equipment

Personnel

Documentation

Change

Blinding

Randomisation

Personnel

Training

The Organisation for Professionals in Regulatory Affairs

13

Blinding

• Blinding during administration as well as packing / shipping • Single Blind

• Double / Triple Blind • Placebo Formulation • Over-encapsulation • Double Blind / Double Dummy • ‘Blinded Pharmacist’

The Organisation for Professionals in Regulatory Affairs

14

7