Standard Operating Procedure for Visual Inspection of Gels
1) Purpose
The purpose of this SOP is to define procedures for visually inspecting finished gels to ensure they meet quality standards and are free from defects before release for distribution or further processing.
2) Scope
This SOP applies to the Quality Assurance (QA) and Production departments responsible for visually inspecting gels at various stages of production within the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Assurance (QA): Oversee visual inspection procedures and ensure compliance with SOPs and regulatory requirements.
Production: Perform visual inspections of gels during manufacturing to identify defects and ensure adherence to quality standards.
Packaging: Inspect finished gels before packaging to verify product appearance and integrity.
4) Procedure
4.1 Visual Inspection Criteria
4.1.1 Establish visual inspection criteria based on product specifications, including color, texture, consistency, and absence of foreign particles.
4.1.2 Ensure adequate lighting and inspection tools (e.g., magnifying glass) are available for accurate evaluation.
4.2 Inspection Points
4.2.1 Conduct visual inspections at critical stages of gel production, including raw material inspection, in-process checks, and final product inspection.
4.2.2 Document inspection findings, noting any deviations from acceptance criteria or quality standards.
4.3 Sampling and Testing
4.3.1 Select representative samples of gels for detailed visual inspection and testing.
4.3.2 Perform additional tests (e.g., pH testing, viscosity testing) as necessary to confirm product quality and compliance.
4.4 Documentation and Recordkeeping
4.4.1 Maintain detailed records of visual inspections, including inspection dates, results, and any corrective actions taken.
4.4.2 Archive inspection reports and documentation for traceability and regulatory compliance.
4.5 Rejection and Disposition
4.5.1 Identify and segregate any gels that do not meet visual inspection criteria or quality standards.
4.5.2 Initiate appropriate actions for rejected gels, including rework, disposal, or further investigation as per SOPs.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
– Visual Inspection Checklist
– Inspection Report Forms
– Non-Conformance Reports
7) Reference, if any
– Regulatory guidelines on visual inspection of pharmaceutical products (e.g., FDA, EMA)
– Company-specific quality control procedures and standards
8) SOP Version
Version 1.0