About the Critical Factors course for Sterile Product Manufacturing in Pharmaceutical Industry

Sterile Product Manufacturing in Pharmaceutical Industry course topics include:  RABS & Isolator Technology, Sterilisation Methods, Aseptic Processing & Process Simulation, HVAC, Microbial Contamination Transfer, Control Measures, Liquid & Air Filtration, ISO Requirements, cGMP Requirements to Annex 1, Terminal Sterilisation, EU/China and US Aseptic Processing Guidelines.

This face-to-face course has been designed to provide a comprehensive overview of the critical factors to consider for the preparation of aseptically filled and terminally sterilised products. The course considers the cGMP requirements defined in Annex 1 including the development of a contamination control strategy and introduces risk management tools which have been designed to control microbial contamination in the cleanroom environment, with special consideration to protection of the product.

The course is presented using a blended learning approach consisting of interactive presentations, team-based workshops designed to allow our delegates to put the principles into practice as well as a physical review of a state-of-the-art sterile product manufacturing facility.

To view our full range of training courses please download the Honeyman Training Prospectus.  Book your place now or enquire about our other Pharma Courses – Honeyman Training.

For practical assistance with outsourced monitoring for contamination control in pharmaceutical manufacturing visit www.honeymanlaboratories.com

Who Should Attend This Course?

This course is suitable for all levels of experience and often includes members of the following departments:

• New Graduates
• Operational / Production Supervisors & Managers
• Technical/ Process team members
• Engineering & Validation team members
• QP’s and QA Professionals.

Course Features

This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products.

Sterile Product Manufacturing in Pharmaceutical Industry Training Course Objectives

Key Learning Objectives:-

On completion of the course our delegates will

• Understand the fundamental mechanisms of microbial contamination transfer within the facility and the control measures in place to protect the product.
• Have reviewed the development of the US and EU GMP regulations and ISO guidelines associated with cleanroom design and monitoring as well as review of current requirements.
• Understand the critical control points within a typical aseptic processing operation with focus on RABS and Isolator technology, Liquid & Air Filtration, Sterilisation & Decontamination steps.
• Understand how Cleanrooms are classified with practical examples on how to meet current ISO requirements and interpretation of the cGMP requirements as defined in Annex 1.
• Have participated in workshops to define practical Process Simulation Test for aseptically filled products.
• To understand the key differences between manufacturing operations designed for manufacture of aseptically filled and terminally sterilised products.
• Understand common cGMP deficiencies in sterile product manufacturing operations and what regulatory health inspectors are looking for.