Standard Operating Procedure for Final Product Inspection for Lotions

1) Purpose

The purpose of this SOP is to define procedures for the inspection and release of final lotion products to ensure they meet quality standards and specifications before distribution.

2) Scope

This SOP applies to all personnel involved in the final inspection and release of lotion products within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Quality Control (QC) Personnel:

• Perform final inspection and testing of lotion products according to approved procedures and specifications.
• Verify compliance with batch records and regulatory requirements.

Quality Assurance (QA) Personnel:

• Review and approve final product inspection results and release decisions.
• Ensure adherence to SOPs and GMP guidelines.

Production Personnel:

• Prepare final product batches for inspection and sampling.
• Support QC personnel during inspection activities.

4) Procedure

4.1 Inspection Preparation:

• Retrieve final product batches from storage or production areas for inspection.
• Verify batch records, labels, and documentation for accuracy and completeness.

4.2 Visual Inspection:

• Inspect lotion products for visual defects, including color, consistency, and packaging integrity.
• Compare products against approved standards and specifications.

4.3 Sampling and Testing:

• Collect representative samples from each batch for laboratory testing.
• Perform testing for attributes such as pH, viscosity, microbial limits, and preservative efficacy.

4.4 Documentation and Review:

• Document inspection and testing results accurately and legibly.
• Review batch documentation, including production records, testing certificates, and deviations.

4.5 Release Decision:

• Evaluate inspection and testing results to determine batch release or rejection.
• Authorize product release based on compliance with specifications and approval criteria.

5) Abbreviations, if any

SOP: Standard Operating Procedure

QC: Quality Control

QA: Quality Assurance

6) Documents, if any

• Final Product Inspection Records
• Batch Records
• Testing Certificates

7) Reference, if any

• 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
• USP <1111>: Microbial Examination of Nonsterile Products

8) SOP Version

Version 1.0