Active Pharmaceutical Ingredients - QP Module

Course outiline :

Active Pharmaceutical Ingredients

• The Regulations
  • EU and US regulations and guidelines
  • Drug Master Files and Certificates of Suitability
  • Key GMP guidance – ICH Q7
• Manufacturing Processes and Quality
  • Key issues for…
    • Synthesis
    • Purification and impurity control
    • Packaging
  • Process Validation
• Supply Issues for the Dosage Form Manufacturer
  • Supplier selection and audit
  • Supply chain integrity
  • Technical Agreements
  • Certificates of Analysis

Bulk Biologicals and Biotech Products

• What is a Biological or Biotech Product?
• EU and US Regulatory Aspects
• Essential Characteristics of Biologicals
  • Antibiotics
  • Vaccines
  • Blood products
  • Monoclonal antibodies
• Quality Aspects
  • Control of starting materials
  • Control of cultivation, harvest and purification
  • Analytical and bioassay techniques

Excipients

• Regulatory Environment

GMP Guidances/Codes

​Training link (Site link) : Link