GMP Compliance Efficiencies (1-Page)

Describe why regulatory authorities inspect a pharmaceutical manufacturer against pertinent GMPs. Compare and contrast specific GMPs for the manufacture of for example drug substance versus finished product (e.g. ICH Q7 versus 21 CFR Part 211). Summarise the GMPs requirement for ‘Validation'.

1.1 Key Enablers for a QMS (1-Page)

Describe the business drivers for a QMS and the key enablers to make a QMS successful. Briefly describe a ‘Product Realisation' strategy that aligns design activities against specification activities.

1.2 Cost Effective Validation (1-Page)

Describe an efficient approach to ‘Validation' driven by subject matter expertise and risk based decision making.