Presented by
Management Forum

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.

1-2 Dec 2021 + 1 more date

Enrol now

  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

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

Enrol now

The Stability Testing of Pharmaceuticals and Biopharmaceuticals course will cover:

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

Enrol now

Allan Watkinson

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

More details

Ray Munden

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.

More details

Book Stability Testing of Pharmaceuticals and Biopharmaceuticals Live online training

1-2 Dec 2021

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 11018

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 27 Oct

View basket 

14-15 Jul 2022

Live online

09:30-17:15 UK (London) (UTC+01)
10:30-18:15 Paris (UTC+02)
04:30-12:15 New York (UTC-04)
Course code 11684

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 09 Jun

View basket 

Reviews of IPI's Stability Testing of Pharmaceuticals and Biopharmaceuticals training course


Very good.

Jul 12 2021

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

Dec 4 2019

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 4 2019

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

Jul 3 2019

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 4 2018

[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 4 2018

Very good, informative, good pace.

Tim Liddy
QC Supervisor, Perrigo UK

Dec 5 2017

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

Joanna Seiffert
Senior Principle Scientist, Trio Medicines

Dec 5 2017

Very well managed and presented course, thank you.

Jane Stevens
Stability Analyst, Torbay Pharmacy Manufacturing Unit

Dec 5 2017

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

Lola Cascino
QC Scientist, G-Pharm Ltd

Jul 5 2017

Speaker knows his stuff. He answered all questions to the best of his ability. He was very nice and professional.

yetunde Bode
Regulatory Affairs Team Leader (UK Team), RPH Pharmaceuticals AB

Jul 5 2017

Very comprehensive but digestible.

Matthew Lait
Regulatory Affairs Officer, RPH Pharmaceuticals AB

Jul 5 2017

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

Dec 5 2017

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

Ania Masters
Section head of stability, Bard Pharmaceuticals

Dec 5 2017

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

James Murray
Medical Chemist, Mexichem UK Limited

Dec 5 2017

Covered all I needed.

Claire McGuinness
Research Chemist, Mexichem UK Limited

Dec 5 2017

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

Jul 5 2017

Really good.

Thundiyil Pintoo
R&D Analytical Laboratory Manager, Ginsana SA

Jul 5 2017

Very useful.

Jonathan Purdye
Chemistry Laboratory Manager, Torbay Pharmacy Manufacturing Unit

Dec 6 2016

Speakers were very helpful and experienced.

Lisa Cole
Senior Medical Information Officer, Fresenius Kabi

Jul 6 2016

The speaker was receptive to participant comments and questions, the content was organized and easy to follow, the materials distributed were pertinent and useful. Thank you for an interesting course!

Sandra Lickova
Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG

Dec 6 2016

Useful course with applied knowledge information.

Gill French
Astrazeneca

Dec 6 2016

Ray is an expert in the field and his knowledge, enthusiasm and willingness to answer questions and target as we go have made the training interactive and enjoyable.

Blagovesta Tomova
Senior Scientist , LGC

Jul 6 2016

It is a good course about stability.

Maria Jose Fernandez
CHEMO Espana SL

Jul 6 2016

The course was enjoyable with good content and the speakers were able to answer all my questions.

Mark Bell
Bard Pharmaceuticals

UK

  • Torbay Pharmaceuticals
  • Actavis Biologics Ltd
  • Allergy Therapeutics
  • Astrazeneca
  • AstraZeneca Operations
  • Bard Pharmaceuticals
  • Bio Products Laboratory Limited
  • Calderdale and Huddersfield Solutions Ltd
  • Colonis Pharma
  • ConvaTec UK Ltd
  • Fresenius Kabi
  • G-Pharm Ltd
  • GW Pharma Ltd
  • Hameln Pharmaceuticals Ltd
  • LGC
  • LGC Ltd
  • MeiraGTx
  • Mexichem UK Limited
  • Mylan
  • Nelson's
  • Nicobrand Limited
  • Novartis Animal Health
  • Perrigo
  • Perrigo UK
  • Protherics UK Limited
  • RPH Pharmaceuticals AB
  • sanofi
  • Seven Seas Ltd
  • Special Products Ltd
  • TEVA
  • Teva UK Ltd
  • Torbay Pharmaceuticals
  • Torbay Pharmacy Manufacturing Unit
  • Trio Medicines
  • Vericore Limited
  • Veterinary Medicines Directorate

Sweden

  • AstraZeneca
  • BioInvent International
  • Camurus AB
  • QPharma
  • Recipharm

Switzerland

  • Ares Trading S.A - affilitate of Merck Serono SA
  • Dr. E. Graeub AG
  • Ginsana SA
  • Sintetica

Belgium

  • CIRLAM bvba
  • GlaxoSmithKline Vaccines
  • Zoetis Belgium SA

France

  • 3X Consultants
  • Aptar France
  • orphan europe

Austria

  • Gebro Pharma GmbH
  • Valneva Austria GmbH

Denmark

  • ALK-Abelló A/S
  • Novo Nordisk A/S

Germany

  • Cheplapharm Arzneimittel GmbH
  • Fresenius Kabi Deutschland GmbH

Lebanon

  • Benta S.A.L
  • Benta SAL

Spain

  • CHEMO Espana SL
  • Laboratorios Almirall S A

Croatia

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Greece

  • Elpen Pharmaceutical Co Inc

Ireland

  • Allergan Pharmaceuticals (Ireland)

Italy

  • Zambon SpA

Netherlands

  • Curium Netherlands B.V.

Saudi Arabia

  • Saudi Food and Drug Authority

Slovenia

  • LEK Pharmaceuticals d.d.

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy