Stability Testing of Pharmaceuticals

This In-house programme will show the team how to design efficient stability studies that are suitable for global marketing, and how to carry out appropriate stability studies and manage stability samples and facilities.

In-house Training Services and Consultancy

This comprehensive two-day In-house programme will show the team how to design efficient stability studies that are suitable for global marketing, be able to carry out appropriate stability studies and manage stability samples and facilities. Also know how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols

Your team will:

  • Gain knowledge on storage tests, conditions and protocols
  • Learn how to design protocols for global marketing
  • Discover how to manage stability Samples and Facilities
  • Develop robust Stability Indicating Methods
  • Comply with stability requirements for existing products and line extensions
  • Understand what stability testing is required following changes to a product
  • Discuss data treatment, shelf life assignment and extrapolation

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme - Day One

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

Developing robust, Stability Indicating Methods

  • Producing impurities
  • Guidance on stress testing
  • Producing potential impurities of synthesis
  • Producing potential impurities of degradation
  • Choosing columns and mobile phases • Identifying important method parameters
  • Optimising method parameters • Ensuring the method is robust

Stability requirements for existing products and line extensions

  • Guidelines available
  • Requirements for active ingredients
  • Requirements for product
  • Requirements for variations to marketed products
  • Designing a more complex stability protocol

Management of stability samples

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

Sample programme - Day Two

Developing robust, stability indicating methods

  • Producing impurities
  • Guidance on stress testing
  • Producing potential impurities of synthesis
  • Producing potential impurities of degradation
  • Choosing columns and mobile phases
  • Identifying important method parameters
  • Optimising method parameters
  • Ensuring the method is robust

Data treatment, shelf life assignment and extrapolation

  • When is statistical treatment required?
  • How much extrapolation beyond real time data is allowable?
  • OOS/OOT results

Light stability testing

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

Packaging considerations

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

Sundry considerations

  • Bulk stability
  • Pharmaceuticals manufactured in Zones III and IV for sale in Zone II
  • How to be inspection ready
  • Accelerated Stability Assessment Testing (ASAP)

Matrixing and bracketing stability studies

  • Bracketing designs
  • Matrixing designs
  • ICH Q1D guidelines
  • What is acceptable for bracketing and matrixing
  • Designing efficient stability protocols

Recommended trainer

Dr Raymond Munden

Dr. Raymond Munden has over 30 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 is an expert 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.