Standard Operating Procedure for Label Inspection for Gels
1) Purpose
The purpose of this SOP is to define procedures for inspecting labels used on gels to ensure accuracy, completeness, and compliance with regulatory requirements.
2) Scope
This SOP applies to the Quality Assurance (QA) and Packaging departments responsible for inspecting labels for gels at the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Assurance (QA): Oversee label inspection procedures and ensure compliance with SOPs and regulatory guidelines.
Packaging: Perform visual inspections of labels and ensure they meet specified requirements before use on gels packaging.
Production: Coordinate with QA and Packaging departments to ensure timely availability and accuracy of labels.
4) Procedure
4.1 Receipt and Verification of Labels
4.1.1 Receive labels from approved suppliers and verify their identity, quantity, and compliance with purchase specifications.
4.1.2 Store labels in designated areas under controlled conditions to prevent damage or deterioration.
4.2 Label Inspection Process
4.2.1 Conduct initial visual inspection of labels for accuracy, legibility, and completeness of information (e.g., product name, strength, batch number).
4.2.2 Check that labels conform to approved artwork and regulatory requirements (e.g., font size, color, placement).
4.3 Label Sampling and Testing
4.3.1 Select representative samples of
4.3.2 Perform label testing for adhesive strength, durability, and resistance to environmental conditions as per protocol.
4.4 Label Reconciliation
4.4.1 Ensure accurate reconciliation of labels used during packaging operations with batch records.
4.4.2 Document any discrepancies or deviations identified during label inspection and reconciliation.
4.5 Documentation and Recordkeeping
4.5.1 Maintain accurate records of label inspections, including inspection dates, results, and any corrective actions taken.
4.5.2 Archive label samples and inspection reports for traceability and future reference as per regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
– Label Inspection Checklist
– Label Testing Records
– Label Reconciliation Reports
7) Reference, if any
– Regulatory guidelines on labeling requirements for pharmaceutical products (e.g., FDA, EMA)
– Company-specific labeling procedures and standards
8) SOP Version
Version 1.0
