Manufacturing Sterile Products

Mastering Sterile Product Lifecycle and Navigating EU GMP Annex 1 Compliance

With the final clause of the EU GMP Annex 1 update on sterile products implemented on 25th August 2024, companies are now expected to now be fully compliant with the new requirements. This two-day course has been aligned with the updated Annex 1 and takes you through a sterile product lifecycle considering the aspects of formulation, manufacturing, and control of sterile products. Within this the areas of cleanroom design and operation are reviewed as are the controls around entry of materials, equipment and most importantly people.

Read further course information Read further course information
Duration
2 days
CPD Hours
14 hrs
Locations
  • Online

Who Should Attend

This course will provide valuable underpinning knowledge to all personnel working for companies responsible for the manufacture of sterile products including sterile Active Pharmaceutical Ingredients (APIs) and other sterile materials. It will be of benefit to those working in sterile products manufacturing, quality assurance and quality control as well as support areas such as engineering and training. You might be new to your team or experienced (looking for an update to your knowledge). Either way this course would be ideal for you.

Shutterstock 1268263642 (1)

Key topics

This course includes the following topics: 

  • Icon

    Introduction to sterile products and why they are important 

  • Icon

    Regulatory requirements and guidelines for manufacturing sterile products  

  • Icon

    Formulation and primary packaging considerations

  • Icon

    An introduction to microorganisms  

  • Icon

    Contamination control and clean room design   

  • Icon

    Controls around people, materials and equipment   

  • Icon

    Control of critical utilities including water  

  • Icon

    Steam sterilisation processes and concepts of D and Z values   

  • Icon

    Process lethality and the F0 concept  

  • Icon

    Sterilisation by dry heat, irradiation, gassing and filtration  

  • Icon

    Disinfection and microbiological environmental monitoring  

  • Icon

    Aseptic process simulations  

  • Icon

    Testing of sterile products 

Learning Outcomes

At the end of the course you will: 

  • Icon

    Understand the risks associated with sterile products

  • Icon

    Appreciate the requirements for contamination control and how this links to clean room design 

  • Icon

    Understand the controls needed for materials, equipment and utilities  

  • Icon

    Understand the methods for terminal sterilisation and processes involved in aseptic product manufacture  

  • Icon

    Understand the different types of sterilisation and how they can be applied  

  • Icon

    Appreciate the importance of people and the need for trained personnel  

  • Icon

    Appreciate the role of product testing 

Meet your expert tutors

Learn from the best in the industry.  Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

Andy Martin

Andy Martin

With over 35 years of pharmaceutical industry experience, Andy began his working life as a Microbiologist in 1985, later progressing to QA Microbiology Manager. During his long career, Andy has gained experience in across a wide range of QA and QC activities. In 2003, Andy become RSSL’s Pharmaceutical Training Manager with responsibility for providing insightful commercial training courses for those looking to enhance their knowledge and prospects.
Frequently asked questions

If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.

What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Interesting and very relevant to my line of work

The course was interesting and very relevant to my line of work. It was a small group with lots of interaction with the course tutor. It helped with my continuous professional development, as my aim is to be able to certify sterile medicinal products.
Mike Ashworth
Morningside Pharmaceuticals Ltd - Lead QP

A thought provoking course

The tutor was very engaging, with the course proving to be thought provoking.
Lisa Parkhouse
Sharp Clinical Services (UK) Ltd - Quality Manager / QP

Book Your Place

Manufacturing Sterile Products
30 Jul 2025
-
Online
25 Nov 2025
-
Online
£1640 excl VAT
Shutterstock 1166562313 (1)

Bespoke Training

We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.

Bring this course in-house Bring this course in-house

Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Apply for Discount Apply for Discount

Further courses to consider

Cleaning Validation
From 14 Oct 1 day

Explore the issues and pitfalls you may experience when performing Cleaning Validation


£820 ex VAT
Virtual tutor-led
Introduction to Validation
From 1 Oct 1 day

Gain a topic overview including responsibilities, change management and verification.


£590 ex VAT
Virtual tutor-led

Why choose RSSL?

As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.

  • Icon

    More than 30 years of experience upskilling pharmaceutical professionals

  • Icon

    Small-group training adjusted to individual learning styles and needs

  • Icon

    50+ training courses accredited by recognised industry bodies

  • Icon

    Combination of off-the-shelf and bespoke training packages

  • Icon

    Courses and consulting led by experts in the entire pharmaceutical life cycle

  • Icon

    Opportunity to share and learn as part of a diverse community