Critical Factors for Sterile Product Manufacturing

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  • Critical Factors for Sterile Product Manufacturing

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  • Critical Factors for Sterile Product Manufacturing

    We have produced an overview of the course information available online, available here in a handy PDF Prospectus.

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Course Terms & Conditions

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

New Sterile Product Manufacturing in Pharmaceutical Industry 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.

Sterile Product Manufacturing in Pharmaceutical Industry

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?

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.

Sterile Product Manufacturing in Pharmaceutical Industry Training 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.

Training prospectus 2022

We have produced an overview of the course information available online, available here in a handy PDF Prospectus.

Our Customers

Our team has trained and works with the world's leading Pharmaceutical companies, including …

Latest News

7th October 2022

Glossary (European) – Manufacture of Sterile Medicinal Products

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2nd September 2022

Technical Briefing (PDF): Airborne particle counting using LSAPC

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6th May 2022

Planetary Protection – ESA

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12th April 2022

Sterilisation Critical Control Points

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12th June 2021

Risk Management of Contamination (RMC)

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3rd May 2021

Annex 1 Revision 2020

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