Standard Operating Procedure for Final Product Inspection for Gels
1) Purpose
The purpose of this SOP is to establish procedures for the inspection and release of final products of gels to ensure compliance with specifications, quality standards, and regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the final inspection and release of gels within the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC) Inspector: Perform final product inspection according to this SOP.
Quality Assurance (QA) Team: Review inspection results and release final products.
Production Supervisors: Ensure products are ready for final inspection and release.
4) Procedure
4.1 Inspection Preparation
4.1.1 Verify completion of all production and packaging activities before inspection.
4.1.2 Ensure all required documentation, including batch records and certificates of analysis, are available.
4.2 Sampling
4.2.1 Select representative samples from each batch for inspection.
4.2.2 Follow sampling procedures to ensure samples are taken in accordance with sampling plans.
4.3 Inspection Criteria
4.3.1 Inspect final products for attributes such as appearance, labeling, packaging integrity, and compliance with specifications.
4.3.2 Use approved inspection checklists and criteria to evaluate each sample.
4.4 Testing
4.4.1 Perform final product testing as required by specifications (e.g., pH, viscosity, microbial limits).
4.4.2 Record and evaluate test results against acceptance criteria.
4.5 Decision Making
4.5.1 Make release or rejection decisions based on inspection and testing results.
4.5.2 Obtain necessary approvals from QA before releasing products for distribution.
4.6 Documentation and Records
4.6.1 Document all inspection findings, test results, and decisions made during the inspection process.
4.6.2 Maintain complete and traceable records of final product inspections.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Final Product Inspection Reports
– Batch Release Certificates
– SOP for Product Sampling and Testing
7) Reference, if any
– FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– Company-specific quality control and release procedures
8) SOP Version
Version 1.0