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Stability Testing of Pharmaceuticals and Biopharmaceuticals

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.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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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

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

Biopharmaceutical stability

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

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


Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at or contact us below:

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Continuing professional development

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

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 14-15 Jul 2022

Book now

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Previous customers include...

  • Torbay Pharmaceuticals
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • AstraZeneca Operations
  • Bard Pharmaceuticals
  • Bard Pharmaceuticals Ltd
  • Benta SAL
  • ConvaTec UK Ltd
  • Dr. E. Graeub AG
  • Fresenius Kabi Deutschland GmbH
  • Gebro Pharma GmbH
  • Ginsana SA
  • GW Pharma Ltd
  • Mexichem UK Limited
  • Novo Nordisk A/S
  • orphan europe
  • Perrigo
  • QPharma
  • Recipharm
  • RPH Pharmaceuticals AB
  • Saudi Food and Drug Authority
  • Sintetica
  • Special Products Ltd
  • TEVA
  • Torbay Pharmaceuticals
  • Torbay Pharmacy Manufacturing Unit
  • Trio Medicines
  • Valneva Austria GmbH
  • Vericore Limited
  • Zambon SpA

The webinar was really informative and speakers were great. I would highly recommend this course.

Valeria Ciapessoni, Pharmaceutical Development Laboratory Analyst, Sintetica, Dec 21

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