Standard Operating Procedure for Label Inspection for Creams
1) Purpose
The purpose of this SOP is to define procedures for the inspection of labels used in creams packaging. This ensures that labels meet specified requirements for accuracy, legibility, and compliance with regulatory standards.
2) Scope
This SOP applies to the Quality Assurance Department responsible for conducting label inspections for creams. It covers inspection protocols, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Quality Assurance Manager is responsible for overseeing label inspection activities. QA Inspectors and Production Supervisors are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Label Inspection Preparation
4.1.1 Review approved label specifications, artwork, and regulatory requirements (e.g., product name, strength, dosage form, batch number).
4.1.2 Prepare inspection tools, including magnifying glasses, measuring devices, and lighting equipment.
4.2 Label Inspection Process
4.2.1 Conduct visual inspection of labels for accuracy, alignment, legibility, and adherence to approved specifications.
4.2.2 Verify presence and accuracy of required information (e.g., active ingredients, warnings, storage conditions).
4.3 Sampling
4.3.1 Select representative samples of labels from each batch or lot for inspection.
4.3.2 Ensure samples are selected randomly and include labels from different printing runs or batches.
4.4 Acceptance Criteria
4.4.1 Define acceptance criteria based on regulatory standards and approved label specifications.
4.4.2 Evaluate labels against acceptance criteria to ensure compliance with labeling requirements.
4.5 Documentation and Reporting
4.5.1 Document label inspection results, including findings, deviations, and corrective actions taken.
4.5.2 Prepare label inspection reports summarizing inspection procedures, results, conclusions, and any discrepancies identified.
4.5.3 Obtain approval from Quality Assurance Management for label inspection reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Approved Label Specifications
Label Inspection Reports
Regulatory Guidelines on Labeling
7) Reference, if any
FDA Labeling Regulations
Company-specific labeling standards and procedures
8) SOP Version
Version 1.0