Standard Operating Procedure for Quality Control of Packaging and Labeling

1) Purpose

This SOP outlines the procedures for ensuring the quality control of packaging materials and labeling used in the manufacture of pharmaceutical products to ensure compliance with regulatory requirements and product specifications.

2) Scope

This SOP applies to all packaging materials and labeling used for pharmaceutical products, including primary packaging materials, secondary packaging, and product labeling.

3) Responsibilities

The Quality Control Manager or designated personnel are responsible for overseeing the quality control of packaging and labeling. Production, quality assurance, regulatory affairs, and other relevant departments are responsible for implementing procedures outlined in this SOP.

4) Procedure

4.1 Receipt and Inspection of Packaging Materials

1. Receive packaging materials from approved suppliers and verify against purchase orders and specifications.
2. Inspect packaging materials for damage, defects, and compliance with quality standards and specifications.

4.2 Sampling and Testing

1. Sample packaging materials according to sampling plans and procedures based on regulatory requirements and internal policies.
2. Perform testing and analysis of packaging materials, including dimensional checks, visual inspection, functional testing (e.g., closure integrity), and compatibility testing.

4.3 Labeling Control

1. Verify the accuracy and completeness of labeling content, including product name, strength, dosage form, batch number, expiration date, and other required information.
2. Ensure compliance with regulatory requirements, company standards, and approved artwork.

4.4 Documentation and Record Keeping

1. Maintain accurate records of receipt, inspection, sampling, testing, and release of packaging materials and labeling.
2. Document any deviations, non-conformances, or quality issues encountered during the inspection and testing process.

4.5 Release or Rejection Decision

1. Make release or rejection decisions based on the results of inspection, testing, and compliance review.
2. Communicate release status to production and ensure only approved packaging materials and labeling are used for manufacturing.

4.6 Change Control

1. Implement a change control process to manage any changes to packaging materials, labeling specifications, or processes.
2. Ensure changes are documented, assessed for impact on quality, and approved prior to implementation.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Packaging Material Inspection Reports, Labeling Compliance Records, Test Results, Deviation Reports, Change Control Records

7) Reference, if any

Regulatory guidelines and requirements for packaging and labeling control, such as FDA regulations on labeling and packaging requirements for pharmaceutical products.

8) SOP Version

Version 1.0