Drug Substances and Vendor Management

This course relates to the manufacturing of drug substances (Active Pharmaceutical Ingredients) and vendor management.

This highly interactive course, is part of NSF’s training program for the Certificate in Pharmaceutical Quality, linked to the US FDA’s 6 systems approach.

Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent following registration.

You will learn:

• The requirements in ICH Q7 for the GMP of Drug Substances
• How to meet US Regulatory requirements and GMP guidance
• The major differences between chemical synthesis and bioprocesses
• How to manage change of Drug Substance source
• Vendor management of Drug Substance supply chains

For chemically synthesized and biological/biotech produced Drug Substances, the course includes:

• Common unit process steps and their effect on the quality of the final drug substance
• How GMP is implemented across the key production unit processes from starting materials through to packaging and distribution of drug substances
• Vendor assurance and management of supply chains including auditing of facilities

Active Pharmaceutical Ingredients

• The regulations
  • ICH Q7
• Manufacturing processes and quality
  • Key issues for:
    • Synthesis
    • Purification and impurity control, including nitrosamines
    • Rework and reprocessing
    • Management of solvents
    • Packaging
• Supply issues for the drug product manufacturer
  • Vendor selection and assessment/audit
  • Oversight of vendors
  • Supply chain integrity
  • Technical/quality agreements
  • Certificates of analysis

Quality Unit Professionals and Pharmaceutical Technical Professionals

• These courses are suitable for professionals working at drug substance manufacturing sites and those whose role requires them to understand manufacturing processes, such as auditors, staff with quality oversight responsibilities and regulators.
• Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development.

Course tutors will be selected from the following:

• Dave Waddington
• Marie O’Callaghan
• Matt Peplowski
• Kelly Anderson