Testing Finished Products in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for testing finished products during the formulation development process, ensuring that products meet predefined specifications and quality standards before release.

2) Scope

This SOP applies to all formulation development projects within the organization, covering finished product testing activities from final manufacturing stages through to release for distribution.

3) Responsibilities

The responsibilities for this SOP include:
Quality Control: Performing finished product testing according to approved testing protocols and methods.
Quality Assurance: Reviewing and approving finished product testing procedures and results to ensure compliance with specifications.
Production Team: Coordinating sample collection and ensuring timely delivery to the quality control laboratory.
Regulatory Affairs: Ensuring finished product testing meets regulatory requirements and supporting submissions.

4) Procedure

4.1 Testing Protocol Preparation

1. Develop a testing protocol outlining testing parameters, methods, and acceptance criteria for finished product testing.
2. Include specifications for critical quality attributes (CQAs), potency, purity, and other relevant parameters.
3. Obtain approval for the testing protocol from quality assurance and stakeholders.

4.2 Sample Collection and Preparation

1. Collect representative samples of finished products according to sampling plans and procedures.
2. Label and transport samples to the quality control laboratory under controlled conditions.
3. Ensure samples are representative of batch production and adequately stored before testing.

4.3 Performance of Testing

1. Perform testing procedures as per approved testing protocols and standard operating procedures (SOPs).
2. Conduct tests for potency, purity, identity, dissolution, and other specified attributes.
3. Use validated analytical methods and equipment calibrated as per defined procedures.

4.4 Evaluation and Interpretation of Results

1. Evaluate finished product test results against 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 finished product testing records.

4.5 Reporting and Release

1. Compile testing data and results into a comprehensive test report or certificate of analysis (CoA).
2. Include detailed information on testing methods, results, deviations, and corrective actions taken.
3. Obtain review and approval of the test report or CoA from designated approvers.
4. Release finished products for distribution based on approved testing results and release criteria.

5) Abbreviations, if any

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

6) Documents, if any

Testing Protocol
Testing Records
Deviation Reports
Certificate of Analysis

7) Reference, if any

– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– FDA Guidance for Industry: Specifications – Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products

8) SOP Version

Version 1.0