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 and can be engaged with on a voluntary basis.

These materials are intended to support your method development and validation programme, whether that’s for small molecules, advanced therapies or to support you make sustainability changes to your laboratory and quality control testing. 

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 here.

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 here.

Environmental hub

The BP ​​​​​​have developed an environmental sustainability information pack as a first step towards encouraging users to adopt more sustainable practices. The environmental sustainability information pack will help you to identify what changes you can make to your laboratory practices and quality control testing methods to reduce your impact on the environment.​​​​​

You can learn more about and download a copy of the environmental sustainability information pack.