Analytical Procedure Development

Since there is no ICH guideline on Analytical Procedure Development, applicants often report analytical validation results alone and rarely present performance evaluation with analytical development outcomes.

This makes regulatory communication ineffective especially when non-conventional (for example, real time release testing) analytical procedures are employed.

Additionally, the lack of guidelines precludes the applicant from an opportunity to present scientific basis for flexible regulatory approaches to post-approval Analytical Procedure changes.

The guideline is proposed for harmonising the scientific approaches of Analytical Procedure Development, and providing the principles relating to the description of Analytical Procedure Development process.

Applying this guideline will improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products. These analytics would be modified or improved throughout the product lifecycle because of continual improvement activities.

Thus, the guideline will provide an opportunity to present the outcome of Analytical Procedure Development in traditional approaches and in enhanced approaches and facilitate efficient and science-based change management by improving communication between industry and regulators.

Some of main technical and scientific elements, which require harmonization, include:

- Submission of Analytical Procedure Development and related information in CTD format

- The concept and strategy of enhanced approaches for Analytical Procedures

- Performance criteria of Analytical Procedures.

- In line with ICH Q8 and ICH Q11, greater understanding of Analytical Procedure can create the basis for more efficient, sound science and risked-based change management (e.g., using analytical Quality by Design principles).

- Key elements and terminology

- Demonstration of suitability for Real Time Release testing.

The new Analytical Procedure Development guideline (Q14) will be for S4, P4 and P5 of CTD and will complement with Q8(R2) and Q11.

The proposed guideline will facilitate selecting or identifying development approaches that will streamline post- approval changes to procedures and enable more efficient, sound science- and risk-based change management. Applying the enhanced approach for analytical procedures can contribute to the resource-efficient drug development and post-approval CMC changes.

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Resource Person: BARBARA PIROLA

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