Standard Operating Procedure for Labeling of Gels
1) Purpose
The purpose of this SOP is to provide guidelines for the labeling of gels in the pharmaceutical industry to ensure accurate identification, regulatory compliance, and consumer safety.
2) Scope
This SOP applies to all personnel involved in the labeling of gels within the pharmaceutical production facility.
3) Responsibilities
Labeling Supervisor: Oversee the labeling process and ensure adherence to this SOP.
Labeling Operators: Execute labeling steps as per the outlined procedure.
Quality Control (QC) Personnel: Verify that labeling operations meet specified standards.
4) Procedure
4.1 Label Design and Approval
4.1.1 Design labels according to regulatory requirements and product specifications.
4.1.2 Obtain approval for label design from the appropriate authorities.
4.2 Label Preparation
4.2.1 Ensure all labeling materials (labels, ink, adhesive) are verified and suitable for use.
4.2.2 Print or prepare labels with accurate information including product name, strength, batch number, expiry date, and any required warnings or precautions.
4.3 Label Application
4.3.1 Clean and sanitize the labeling area and equipment according to the cleaning SOP.
4.3.2 Apply labels to gel containers manually or using automated labeling equipment.
4.3.3 Ensure labels are applied straight, securely, and without wrinkles or bubbles.
4.4 Inspection and Verification
4.4.1 Inspect labeled containers for accuracy and adherence to labeling specifications.
4.4.2 Verify each label for correctness of information and legibility.
4.5 Reconciliation and Documentation
4.5.1 Reconcile the number of labeled containers with the batch record and label issuance log.
4.5.2 Document any discrepancies or labeling errors encountered during the process.
4.6 Final Approval and Release
4.6.1 Submit labeled containers and documentation to QC for final inspection and approval.
4.6.2 Obtain QC approval for release of labeled batches for further processing or distribution.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
– Approved Label Designs
– Label Issuance Log
– QC Inspection Reports for Labeling
– Documentation of Labeling Errors and Corrections
7) Reference, if any
– FDA Labeling Guidance for Prescription Drugs, Including Biological Products
– ICH Q10: Pharmaceutical Quality System
– Pharmacopoeial standards applicable to labeling requirements
8) SOP Version
Version 1.0