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