Receipt and Inspection Procedures for Packaging Materials
1) Purpose
The purpose of this SOP is to define the procedure for receiving and inspecting packaging materials to ensure they meet the required quality standards and specifications for use in manufacturing vaginal dosage forms.
2) Scope
This SOP applies to all personnel involved in the receipt and inspection of packaging materials at the pharmaceutical manufacturing facility.
3) Responsibilities
The Warehouse Department is responsible for receiving and inspecting packaging materials. The Quality Control (QC) Department is responsible for verifying the inspection results and approving the materials for use.
4) Procedure
4.1 Receipt of Packaging Materials
- Verify the packaging material delivery against the purchase order for quantity, type, and specifications.
- Inspect the condition of the delivery vehicle and ensure it is clean and suitable for transporting packaging materials.
- Record the details of the delivery in the receiving log, including the date, supplier, and batch numbers.
4.2 Inspection of Packaging Materials
- Move the received packaging materials to the designated inspection area.
- Inspect the packaging materials for any visible damage, contamination, or defects.
- Verify that the packaging materials conform to the specifications outlined in the purchase order and quality standards.
- Sample the packaging materials as per the sampling plan and send the samples to the QC
4.3 QC Testing and Approval
- The QC lab will perform the necessary tests on the samples to ensure they meet the required quality standards.
- Document the test results and compare them with the acceptance criteria.
- If the packaging materials pass the inspection and testing, the QC Department will approve them for use and update the inventory records.
- If the packaging materials fail the inspection or testing, they will be rejected and the supplier will be notified for further action.
4.4 Storage of Approved Packaging Materials
- Move the approved packaging materials to the designated storage area.
- Ensure that the storage conditions (temperature, humidity, cleanliness) are appropriate for the type of packaging materials.
- Maintain proper labeling and documentation for traceability and inventory management.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Receiving log, inspection report, QC test report, inventory record
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, WHO Good Manufacturing Practices: main principles for pharmaceutical products
8) SOP Version
Version 1.0