ICH: Draft Guidelines ICH Q14 und Q2(R2) published

The draft ICH Q14 guideline on analytical procedure development reached stage 2 of the ICH process on 24 March 2022. This also applies to the revised ICH Q2 (R2) guideline on the validation of analytical procedures. Both documents are now in the public consultation phase. They jointly describe the development and validation activities that should be applied during the life cycle of an analytical procedure to assess the quality of medicinal substances and products.

The 38-page draft guidance on ICH Q2(R2) has been adapted to the latest state of the art. The validation of an analytical method over the entire life cycle, its "robustness" and multivariate analyses are now taken into account. Modern analytical methods, such as RTRT (real time release testing) or NIR (near infrared spectroscopy), which were not previously considered in the ICH Q2 guideline but are already used in practice, are also covered as are statistical evaluations for the validation of modern analytical procedures: Two annexes on the selection of validation tests based on the analytical method and with illustrative examples for analytical techniques have been added.

The 64-page ICH Q14 draft guideline aims to harmonise scientific approaches to analytical method development and describes the principles for their process description, change management and submission requirements for a minimal and extended approach. Applicants should be supported in not submitting analytical validation results in isolation but presenting them in the context of a performance evaluation against corresponding analytical development results. This is expected to significantly improve communication between industry and regulators and achieve a more efficient, science-based, and risk-based approval. This in turn should facilitate post-approval change management of analytical procedures.

The proposed Q2(R2) and Q14 guidelines are intended to complement the ICH guidelines Q8 to Q12, as well as the current ICH guideline Q13 for continuous manufacturing. It is also considered, whether the guidelines could potentially be merged into one document for simplification and clarity.

Both documents are expected to be finalised in May 2023. Click here to access the draft documents, as well as the associated comprehensive ICH presentation on the topic.

Source:

ICH: Newsroom