Guidance for Manufacturing of Biological APIs for Use in Trials

The general requirements for manufacture of clinical supplies are mentioned throughout the FDA and other regulatory and guidance documents.

The Q7A ICH Guideline clearly states: “… controls used in the manufacture of APIs for use on clinical trials should be consistent with the stage of development of the drug product incorporating the API. Process and test procedures should be flexible to provide for changes as knowledge of the process increases and clinical testing of a drug product progresses from pre-clinical stages through clinical stages. Once drug development reaches the stage where the API is produced for use in drug products intended for clinical trials, manufactures should ensure that APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of API.”

However, there is very little reference as to what exactly is appropriate for manufacturing of clinical supplies at different stages of product development. There is an apparent need for a guide document addressing specifically the GMPs for the manufacturing phases of clinical materials.

This matrix guidance provides a balanced overview of GMP requirements for manufactures of clinical supplies for all stages of product development. It will provide recommendations on Quality Systems requirements in all aspects of API manufacturing.

This matrix guideline was developed with a focus on biological products based on regulatory requirements and industry experience.

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