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Critical Factors for Sterile Product Manufacturing

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Critical Factors for Sterile Product Manufacturing

Download print friendly PDF Critical Factors for Sterile Product Manufacture 2018

New course topics include: RABS & Isolator Technology, Sterilisation Methods, Aseptic Processing & Process Simulation, HVAC, HACCP Principles, Cold Chain Transport, Risk Management Workshops.

The manufacture of sterile products is subject to additional GMP controls and relies heavily on the competency and knowledge of everyone involved in the process. This course covers all key aspects of sterile product manufacture, for both aseptically prepared and terminally sterilised products.

Open discussion sessions on current best practices and regulatory trends in sterile product manufacture will be coupled with case studies to illustrate key points. 

Who Should Attend This Course?

Whether involved in Production, QA, QC, Engineering or Regulatory Affairs, this course will be relevant to you.

Course Features

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

Course Objectives

Key learning objectives are:-

  • To review the key activities and processes which are critical to the success of sterile manufacturing operations
  • To refresh delegates on the special nature of sterile products and understand the challenges involved in aseptic processing and the consequences of failure.
  • To develop risk assessment methods and quantify risk
  • To apply risk management techniques to control contamination in clean rooms
  • Understand how the key aspects of the facility design, personnel, material flows, aseptic behaviors determine the success of aseptic processing.
  • How to implement and perform a successful aseptic validation program including practical trail design
  • To understand the current sterilisation & sanitisation processes and controls
  • To understand the importance of critical utilities in sterile product manufacture including steam and high purity water. 
  • To understand the role of QC laboratories in sterile processes
  • To understand the role of the QP in sterile manufacture
  • To review the current regulatory requirements and trends in sterile manufacture
  • To understand common GMP deficiencies and what inspectors are looking for

Course Content

  • Review of international regulatory guidelines related to sterile product manufacture
  • Review of current deficiencies in sterile product manufacture
  • Basic microbiology and sources of contamination
  • Review of critical control points for bio burden control in a typical aseptic process
  • Sterilisation steps including terminal sterilisation
  • Sterilisation processes for irradiation of components
  • Classification and functionality of clean rooms and cleanroom design principles
  • Challenges in aseptic manufacture
  • Risk management of contamination in cleanrooms
  • Risk assessment method, quantification of risk and management
  • Garment gowning procedures and garment management
  • Cleanroom behaviour, personnel movements, disinfection procedures
  • Regulatory expectations for aseptic validation
  • Designing, performing media fills and interpreting results
  • Key aspects of quality critical utilities, including design, testing and operation
  • Filtration types and theory, filter selection and integrity testing
  • Auditing pharmaceutical QC laboratories
  • Understanding the role and responsibilities of the QP
  • Effective CAPA systems in sterile product manufacture
  • Sterile product inspection techniques including manual, automated and regulatory trends

Course Dates / Costs Description

Honeyman reserves the right to amend any prices at any time.

All advertised prices are exclusive of any applicable VAT or local taxes.

Course Terms & Conditions

Click here to read our Pharmaceutical Training Course Terms & Conditions.

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Critical Factors for Sterile Product Manufacturing

Why Honeyman?

The Honeyman Group has trained thousands of people within the pharmaceutical industry. Our courses continue to remain popular because they provide delegates with a sound understanding of scientific principles in each technical area, complemented by interactive workshops, discussions, practical demonstrations and case studies to put these principles into practice.

All of our courses are delivered by experts who actively work within the pharmaceutical, biopharmaceutical and medical device industries, therefore, we will continue to share pragmatic current best practice advice to enable you to meet current GMP and regulatory expectations.

  • Our speakers are active in the industry today and are able to provide up to the minute experiences and current best practice advice
  • Accredited Specialist Training on selected courses in conjunction with Teesside University
  • We can provide bespoke on site training, perfectly suited to deliver the most effective and relevant training

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