Standard Operating Procedure for Labeling of Aerosol Products
1) Purpose
The purpose of this SOP is to outline the procedures for labeling aerosol products in the pharmaceutical industry, ensuring accurate labeling, compliance with regulatory requirements, and clear identification of product information.
2) Scope
This SOP applies to the labeling department at [Company Name], responsible for labeling aerosol products before distribution and ensuring adherence to labeling guidelines.
3) Responsibilities
Labeling Supervisor: Oversees labeling operations and ensures adherence to SOP.
Labeling Operators: Responsible for applying labels accurately and verifying label information.
Quality Control (QC) Personnel: Conducts checks to ensure label accuracy and compliance.
4) Procedure
4.1 Label Preparation:
4.1.1 Verify the availability and correctness of labels for each batch.
4.1.2 Ensure labels are stored in a controlled environment to prevent damage or mix-up.
4.2 Label Application:
4.2.1 Clean and prepare aerosol containers for labeling.
4.2.2 Apply labels to containers using automated or manual labeling equipment.
4.2.3 Verify correct placement, alignment, and adherence of labels.
4.3 Verification of Label Information:
4.3.1 Check label information including product name, strength, batch number, and expiry date.
4.3.2 Ensure all required regulatory information is included as per guidelines.
4.4 Inspection and Quality Checks:
4.4.1 Conduct visual inspection of labeled aerosol containers for label uniformity
4.4.2 Perform random checks to verify label accuracy and readability.
4.5 Documentation:
4.5.1 Record label application details and any deviations encountered.
4.5.2 Document label inspections and approvals in the batch record.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
Labeling Records
Batch Manufacturing Record (BMR)
7) Reference, if any
FDA Labeling Requirements
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0