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