Standard Operating Procedure for Final Product Inspection for Creams
1) Purpose
The purpose of this SOP is to outline the procedures for conducting final product inspection of creams to ensure they meet quality specifications, are safe for use, and comply with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the final inspection of creams, including quality control (QC) inspectors, production supervisors, and packaging personnel. It covers procedures from final packaging through to release or rejection of finished creams.
3) Responsibilities
It is the responsibility of QC inspectors to perform final product inspections according to this SOP, production supervisors to coordinate inspection activities, and packaging personnel to ensure proper labeling and packaging of finished creams.
4) Procedure
4.1 Inspection Preparation
4.1.1 Verify that all production and packaging operations are complete and documented.
4.1.2 Prepare inspection area with adequate lighting, magnification tools (if required), and reference materials (e.g., specifications, batch records).
4.1.3 Calibrate inspection equipment (e.g., weighing scales, measuring devices) as per schedule.
4.2 Visual Inspection
4.2.1 Conduct visual inspection of each unit or batch of creams for defects such as discoloration, foreign particles, and packaging integrity.
4.2.2 Use standardized inspection criteria and acceptance/rejection criteria based on product specifications.
4.2.3 Record inspection findings and observations in inspection reports or batch records.
4.3 Functional Testing
4.3.1 Perform functional tests as specified (e.g., pump dispensers, container closure systems) to ensure they operate correctly.
4.3.2 Conduct additional tests if required by product specifications (e.g., viscosity, pH) using validated testing methods.
4.3.3 Document all testing results and observations in the batch record or inspection report.
4.4 Sampling and Retention
4.4.1 Collect samples for retention and stability testing as per sampling plan.
4.4.2 Label and store retained samples in designated storage areas with appropriate environmental conditions.
4.4.3 Maintain records of sample retention and stability study initiation.
4.5 Release or Rejection Decision
4.5.1 Evaluate inspection results against acceptance criteria defined in product specifications.
4.5.2 Make a decision to release or reject the batch based on inspection findings and compliance with specifications.
4.5.3 Document release decisions and reasons for rejection in batch records or quality control records.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Batch Records
Inspection Reports
Product Specifications
7) Reference, if any
USP (United States Pharmacopeia) General Chapter on Pharmaceutical Packaging and Distribution
ISO (International Organization for Standardization) 9001: Quality management systems – Requirements
8) SOP Version
Version 1.0