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Route & Process Enabling Pressure Chemistry

Process R&D Process Validation Readiness

Process Validation Readiness

In preparation for validation, a comprehensive understanding of the process is essential. At Asymchem we collaborate closely with clients to craft regulatory strategies that guide the generation of the required supporting data. In Sandwich we bring extensive experience in the design and execution of late-stage development packages to support: RSM designation, CPP identification, FMEA/HAZOP, control strategy and regulatory submissions.

Process Validation Readiness

01

Planning

Engage in a thorough discussion with the client to understand and clarify the project scope. Agree on the type of validation required, whether it is Quality by Design (QbD), enhanced submission, or set-point.
Establish expectations for the site where Process Performance Qualification (PPQ) will begin, determining the appropriate Process Acceptable Ranges (PARs) and Normal Operating Ranges (NORs) for the execution phase.
Co-authoring of a detailed experimental plan to document the optimum approach for the generation of the required data.

02

Execution

Modern process chemistry lab equipment, managed by highly skilled staff, facilitates rapid and consistent experimentation. The use of eLN templates further enhances consistency of execution.
Execution of uni or multivariate experimentation as outlined in the experimental plan.
Comprehensive suite of analytical testing capabilities for data generation in line with experimental plan.
Collaboration with ARD and clients ensures that data is accurately captured and verified, supporting regulatory submissions.
Fate & purge experimentation providing data to support control strategy creation.
Any new impurities that arise are flagged, updating the impurity landscape and enhancing fate and purge knowledge.

03

Data Interpretation

Statistical analysis of DoE experiments is conducted to identify Critical Process Parameters (CPPs)
Data is compiled to establish the appropriate Functional Relationship Table (FRT)
Collaboration with the client is essential to complete the Failure Mode Effects Analysis (FMEA) at the PPQ site.
Integrated process safety generates data to meet the requirements of the PPQ site, including HAZOP or CHAR reports.

04

Documentation

A comprehensive report is completed at the point of PPQ readiness to support any regulatory dossier.
Collaboration with the client is essential to aid regulatory submissions.
Providing a Regulatory Process Description (RPD) is a key deliverable.

Output: Documented Data To Underwrite A Successful Validation
Manufacture And Regulatory Submission

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