Quality Management in Sterile Manufacturing

The sterility of a pharmaceutical product can only be assured when a series of control measures are in place. The sterility test applied to the finished product does not guarantee sterility as only a small part of the batch is tested.

Participants will gain a thorough understanding of the relevant regulatory requirements, sterility assurance measures, and sterility assurance concepts, which helps to develop a critical attitude towards the development and manufacture of sterile products. Including the new Annex 1!

Previously organized by PAO Farmacie, now by PCS Academy.

Professionals in pharmaceutical and biotechnological industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Postgraduate students.

The course is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control, Quality Assurance or Regulatory Affairs who are dealing with complex quality systems. The target audience needs to gain an in-depth understanding of these systems to improve quality management in their own organization.

The course is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands).

• Apply the principles of specific sterility-related subjects, such as monitoring, cleaning and disinfection, sterilization, and validation.
• Interpret the guidelines and common practices, and distinguish these facts from myths.
• Demonstrate a critical attitude towards sterility assurance in sterile manufacturing.

• A thorough understanding of the design and control factors related to the sterility assurance of sterile pharmaceutical products.
• Gained the principles of specific sterility-related subjects, such as monitoring, cleaning and disinfection, sterilization, and validation
• Interpret the guidelines and common practices, and distinguish these facts from myths
• A critical attitude towards sterility assurance in sterile manufacturing

• Microbiology and implications for sterility
• Sterile manufacturing set-up
• Process and facility
  • Sterilization (steam, dry heat, filtration and others)
  • Cleaning and disinfection
  • Cleanroom behavior
  • Pharmaceutical water systems and utilities
• Control
  • Environmental and water monitoring
  • Sterility assurance in practice
  • Validation and qualification (aseptic and analytical methods, operator qualification)
• Releasing the sterile product: The role of the QP in assuring the quality of sterile pharmaceuticals
• Real-life case studies