Production Systems-Sterile Drug Products

This course relates to the manufacturing of sterile drug products. It is one of a series of three courses related to the manufacture of drug products. The three options, sterile drug products, non-sterile drug products and biological products are designed to give participants the opportunity to focus on drug products which are relevant to them.

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.

We teach you the important formulation requirements for this product type and how those requirements influence the performance of the medicine in the body. We also teach you the key processing steps in the production of these dosage forms, as well as critical quality attributes and critical process parameters. We also cover what can go wrong during the processing of drug products and the potential consequences to the safety, quality and efficacy of the medicine.

On completion of this course delegates will know and understand:

• The principles of drug design and formulation and the impact of even minor modifications on bioavailability/bioequivalence.
• The various processes involved in the manufacture of sterile drug products.
• The Good Manufacturing Practice (GMP) issues and challenges to enable informed release decisions.
• How to apply the knowledge to:
  • Risk management
  • Risk assessment
  • Problem solving and decision making
  • Auditing

• Design, qualification and operation of cleanrooms
• Pharmaceutical water systems
• Methods of sterilization and aseptic processing
• Formulation considerations
• Major processing methods
• Critical process steps
• Risk-based decision-making
• Key GMP requirements, including sterility assurance and contamination control

Quality Unit Professionals and Pharmaceutical Technical Professionals

• These courses are suitable for professionals working at drug product 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:

• Tony Mayhall
• Philip Rose
• Joe Day
• Paul Aboody
• Shannon Wills