Performing In-process Testing in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting in-process testing during the formulation development process, ensuring that critical parameters are monitored and controlled to achieve consistent product quality.

2) Scope

This SOP applies to all formulation development projects within the organization, covering in-process testing activities from raw material receipt through to final product manufacturing stages.

3) Responsibilities

The responsibilities for this SOP include:
Production Team: Performing in-process tests according to approved procedures and documenting results.
Quality Control: Monitoring and verifying in-process testing procedures and results to ensure compliance with specifications.
Quality Assurance: Reviewing and approving in-process testing protocols and ensuring adherence to regulatory requirements.
Project Manager: Overseeing in-process testing activities and ensuring alignment with project timelines and objectives.

4) Procedure

4.1 In-process Testing Plan

1. Develop an in-process testing plan based on product formulation, process parameters, and critical quality attributes (CQAs).
2. Define specific in-process tests and acceptance criteria for each manufacturing stage.
3. Obtain approval for the in-process testing plan from quality assurance and stakeholders.

4.2 Execution of In-process Testing

1. Perform in-process tests at defined intervals or stages during manufacturing, as per the approved testing plan.
2. Follow standard operating procedures (SOPs) for sample collection, testing methods, and equipment calibration.
3. Record in-process test results accurately and in real-time during production.

4.3 Evaluation and Interpretation of Results

1. Evaluate in-process test results against predefined acceptance criteria and specifications.
2. Document any deviations or out-of-specification (OOS) results and initiate investigation and corrective actions.
3. Verify completeness and accuracy of data before finalizing in-process testing records.

4.4 Documentation and Reporting

1. Compile in-process testing data and results into a comprehensive report or batch record.
2. Include detailed information on testing methods, results, deviations, and corrective actions taken.
3. Obtain review and approval of in-process testing records from designated approvers.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CQA: Critical Quality Attribute
OOS: Out-of-Specification

6) Documents, if any

In-process Testing Plan
In-process Testing Records
Deviation Reports
Corrective Action Reports

7) Reference, if any

– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– FDA Guidance for Industry: Process Validation: General Principles and Practices

8) SOP Version

Version 1.0