About BP guidance materials

Like our legally effective standards, BP guidance materials are designed to ensure the quality, efficacy, and safety of medicines available in the UK market, however the BP guidance materials are non-mandatory.  These materials are intended to support your method development and validation programme, whether that’s for small molecules or advanced therapies.

Advanced Therapy Medicinal Products (ATMP)

With complexity and risk associated with each stage of assay development, our ATMP guidance offers a practical and phase-appropriate validation tool to help your cell and gene therapy programme succeed

You can learn more about ATMP guidance and download a copy.

Analytical Quality by Design (AQbD)

AQbD is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.

The AQbD guidance will help you ensure that the analytical methods you use are robust and fit-for-purpose. This will enable a better assessment of product quality, and ultimately provide greater assurance to safeguard patient safety

You can learn more about and access AQbD guidance.