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Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

1-2 Dec 2021

& 14-15 Jul 2022

Book now


Course overview

By attending this intensive two-day seminar, delegates will learn how to:

  • Carry out appropriate stability studies and manage stability samples and facilities
  • Design stability studies that are suitable for global marketing
  • Increase the likelihood of studies receiving regulatory approval
  • Save resources on stability testing with potential large financial savings

A series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.

Please note that we are delighted to confirm that this course will now also include particulars of the stability of biopharmaceuticals.

Benefits of attending:

  • Comply with stability requirements for new and existing drug substances, products and line extensions
  • Gain knowledge on storage tests, conditions and protocols
  • Learn how to design highly efficient protocols for global marketing with potentially large financial savings
  • Discover how to manage stability samples and facilities
  • Understand what stability testing is required following changes to a product
  • Discuss data treatment, shelf-life assignment and extrapolation

Who should attend?

Personnel involved in:

  • Stability testing of pharmaceuticals and biopharmaceuticals
  • The design of stability protocols
  • The management of stability samples and facilities
  • The development of pharmaceuticals which require stability testing
  • The production of regulatory documents which include stability data
  • Quality assurance


Background to stability testing and guidelines

  • The rationale for stability testing
  • Relevant guidelines

Storage tests, conditions and protocols

  • Tests for drug substance and product types
  • Storage conditions and periods required
  • Typical protocols
  • Developing global stability protocols
  • In-use testing

Exercise 1: Designing a simple stability protocol

Management of stability samples and facilities

  • Sample management
  • Validation of storage facilities
  • How to treat excursions from condition

Requirements for existing products, line extensions and variations

  • Guidelines available (ICH, EU and USA)
  • Requirements for active ingredient
  • Requirements for product
  • Requirements for variations to marketed products

Exercise 2: Designing a more complex stability protocol

Data treatment, shelf-life assignment and extrapolation

  • When is statistical treatment required?
  • How much extrapolation beyond real-time data is allowable?
  • Presentation of data in submissions
  • Setting shelf-life specifications

Exercise 3: Data treatment

Biopharmaceutical stability

  • ICH Q5C and regulatory guidance
  • Complexity associated with biopharmaceuticals
  • Stability-indicating assays for biopharmaceuticals
  • Stability considerations for new modalities

Light stability testing

  • ICH Q1B guidelines
  • Light sources
  • Required exposure
  • Problems in light testing

Packaging considerations

  • Guidelines
  • Requirements when changing packaging
  • Demonstrating equivalence
  • Permeation considerations
  • Interaction studies

Exercise 4: Packaging

Sundry considerations

  • Bulk stability
  • Manufacture in zones III/IV to be sold in zone I
  • Out-of-specification in stability

Matrixing and bracketing stability studies

  • Bracketing designs
  • Matrixing designs
  • ICH Q1D guidelines
  • What is acceptable for bracketing and matrixing?

Exercise 5: Designing efficient stability protocols


Allan Watkinson (More...) (1-2 Dec 2021, 14-15 Jul 2022)

Allan Watkinson, Director of Biopharmaceutical Development CMC, Covance CRS Analytics Ltd. Allan has many years’ experience in a wide range of CMC activities from process development to biopharmaceutical drug product formulation, and extensive knowledge of protein analytics. As Principal Investigator he has been the technical lead in the development of cold-chain-free thermostable vaccines. Furthermore, he has been instrumental in developing novel analytical techniques for understanding protein structure in particulate biopharmaceutical formulations.

Allan’s main focus now is providing scientific expertise in the biologics analysis and all matters GMP CMC for biopharmaceutical development.  Specialities:

  • Biopharmaceutical analytical development and technology transfer
  • Biologics release testing
  • Stability testing (including developability, accelerated and forced degradation studies)
  • Biotechnology process development cGMP manufacturing
  • Biopharmaceutical formulation and biologics stabilisation

Ray Munden (More...) (1-2 Dec 2021)

Dr Raymond Munden has over 40 years’ experience in pharmaceutical research and development and was formerly Head, Analytical Services Europe for GlaxoSmithKline. He has led project teams that developed many new chemical entities and their pharmaceutical products that were successfully taken to market. Dr Munden has particular expertise in stability protocol design and testing, stability storage facilities, experimental design and degradation chemistry. He is now a consultant for all aspects of pharmaceutical development.

Book now

Book now

1-2 Dec 2021
Live webinar
1-2 Dec 2021
Live webinar
GBP 1,299.00
EUR 1,859.00
USD 2,098.00
+ VAT @ 20.00%
Enrol now
to attend
Live webinar
14-15 Jul 2022
Live webinar
14-15 Jul 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 9 Jun 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Torbay Pharmaceuticals
  • Actavis Biologics Ltd
  • ALK-Abelló A/S
  • Allergy Therapeutics (UK) Ltd.
  • Aptar France SAS
  • Astrazeneca
  • Bard Pharmaceuticals Ltd
  • BioInvent International
  • Camurus AB
  • Colonis Pharma
  • Dr. E. Graeub AG
  • ELPEN Pharmaceutical Co. Inc.
  • GlaxoSmithKline Vaccines
  • Laboratorios Almirall S A
  • LGC
  • LGC Ltd
  • MeiraGTx
  • Mylan
  • Nelson's
  • orphan europe
  • Perrigo
  • Recipharm
  • RPH Pharmaceuticals AB
  • Seven Seas Ltd
  • TEVA
  • Torbay Pharmaceuticals
  • Torbay Pharmacy Manufacturing Unit
  • Vericore Limited
  • Zoetis Belgium SA

Very good.

Sylwia Andrzejewska, Stability Coordinator CTM Analytics Austria, CTM Analytics, Valneva Austria GmbH, Jul 21

Really informative with a good overview of the guidelines and enough real-life examples and exercises to maintain engagement. I reinforced my understanding and gained confidence in designing stability studies efficiently and correctly.

Celia Garland, Medical Affairs Officer, Hameln Pharmaceuticals Ltd, Dec 19

There was great insight given into the background of stability and why it is so important. I would recommend this course to the rest of my team at work.

Yasmin Khimji, QC Analytical Scientist, MeiraGTx, Dec 19

The content was great and covered a lot of areas and aspects. The presentation had a practical flow to the topics. The speaker was very keen on helping and answering any questions.

Holly Harvey, QC Stability Analyst, AstraZeneca Operations, Jul 19

[The speaker was] friendly and helpful. A great course to further understanding of stability. Ray has a wealth of knowledge which was much appreciated.

Emma Grace Hill, Stability Coordinator, Perrigo, Jul 18

Very good, informative, good pace.

Tim Liddy, QC Supervisor, Perrigo UK, Jul 18

Very knowledgeable and patient speaker, useful practical workshops, found content covered what I needed and introduced all relevant guidelines.

Joanna Seiffert, Senior Principle Scientist, Trio Medicines, Dec 17

Well run and presented course. Comprehensive material. Approachable speaker.

Lola Cascino, QC Scientist, G-Pharm Ltd, Dec 17

Covered all I needed.

Claire McGuinness, Research Chemist, Mexichem UK Limited, Dec 17

Excellent, content covered all expected aspects. Speaker was highly knowledgable.

James Murray, Medical Chemist, Mexichem UK Limited, Dec 17

Very good, well spaced breaks and good facilities. Good timings and content .

Ania Masters, Section head of stability, Bard Pharmaceuticals, Dec 17

Very well managed and presented course, thank you.

Jane Stevens, Stability Analyst, Torbay Pharmacy Manufacturing Unit, Dec 17

Well organised, good break structures, good amount of content.

Joanna Seiffert, Senior Principle Scientist, Trio Medicines, Dec 17

Informative, well presented, left me feeling clued up about stability, speaker very good at making you think in new ways to solve issues as well as real examples.

Liam O'Malley, R&D Scientist, TEVA, Jul 17

Very useful.

Jonathan Purdye, Chemistry Laboratory Manager, Torbay Pharmacy Manufacturing Unit, Jul 17