Packaging Inspection Procedures
1) Purpose
The purpose of this SOP is to define the procedure for inspecting packaging materials and ensuring that the final packaged product meets quality standards.
2) Scope
This SOP applies to all packaging materials and final packaged products within the pharmaceutical manufacturing facility.
3) Responsibilities
– QC personnel are responsible for conducting packaging inspections.
– Production personnel must provide samples of packaging materials and packaged products for inspection.
– QA personnel are responsible for reviewing and approving the inspection results.
4) Procedure
1. Receiving Packaging Materials
1.1. Verify that the packaging material containers are properly labeled with the supplier name, material type, batch number, and other relevant information.
1.2. Inspect the condition of the containers for any signs of damage or tampering.
2. Visual Inspection of Packaging Materials
2.1. Open the containers and inspect the packaging materials for:
2.1.1. Defects such as tears, punctures, or deformations
2.1.2. Discoloration or contamination
2.1.3. Proper labeling and
2.2. Use magnifying tools if necessary to detect small defects.
3. Functional Testing of Packaging Materials
3.1. Conduct functional tests, such as seal integrity tests, to ensure the packaging materials perform as expected.
3.2. Record the results of the functional tests and ensure they meet the specified criteria.
4. Inspection of Final Packaged Products
4.1. Collect samples of the final packaged products at regular intervals during the packaging process.
4.2. Inspect the final packaged products for:
4.2.1. Proper sealing and labeling
4.2.2. Absence of defects or contamination
4.2.3. Conformance to packaging specifications and quality standards
5. Documentation
5.1. Record all inspection results on the packaging inspection form.
5.2. Include details such as batch number, date of inspection, and any observations or anomalies.
5.3. Sign and date the inspection form.
6. Acceptance and Rejection
6.1. Accept packaging materials and final products if they meet all specified criteria.
6.2. Reject packaging materials and final products if they show signs of defects or contamination.
6.3. Notify the supplier of any rejected materials and document the rejection.
7. Review and Approval
7.1. Submit the completed inspection forms to the QA department for review.
7.2. QA will review and approve the results based on the criteria outlined in this SOP.
8. Corrective Actions
8.1. If packaging materials or final products are rejected, initiate a corrective action report.
8.2. Document all actions taken to address issues identified during the inspection, including potential adjustments to the packaging process.
5) Abbreviations, if any
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Packaging Inspection Form
– Corrective Action Report Form
7) Reference, if any
– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– USP <661> Containers—Plastics
8) SOP Version
Version 1.0