Standard Operating Procedure for Packaging Material Quality Assurance

1) Purpose

This SOP details the procedures for ensuring the quality of packaging materials used in the pharmaceutical manufacturing process to meet regulatory standards and company quality requirements.

2) Scope

This SOP applies to all packaging materials received, tested, and used in the production and packaging of pharmaceutical products within the company.

3) Responsibilities

The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP. The QA team ensures all packaging materials meet specified quality criteria before use in packaging operations.

4) Procedure

4.1 Receiving Packaging Materials

1. Inspect the delivery vehicle for cleanliness and potential contamination.
2. Verify the supplier documentation, including certificates of compliance and purchase order (PO).
3. Assign a unique identification number to each batch of packaging materials received.

4.2 Sampling and Testing

1. Collect samples of packaging materials according to the company’s sampling plan.
2. Send samples to the Quality Control (QC) laboratory for testing according to predefined specifications.
3. Record all test results in the laboratory information management system (LIMS).

4.3 Acceptance or Rejection

1. Review the QC test results to determine if the packaging materials meet the required specifications.
2. Accept the batch if it passes all tests and update the inventory management system.
3. Reject the batch if it fails any test, quarantine it, and initiate a discrepancy report.

4.4 Storage and Handling

1. Store accepted packaging materials in designated areas under controlled conditions.
2. Ensure that packaging materials are properly labeled with identification numbers, status (accepted/rejected), and expiration dates if applicable.
3. Handle all packaging materials following the company’s safety and handling guidelines.

4.5 Documentation and Records

1. Maintain all records of packaging material receipt, sampling, testing, and disposition.
2. Ensure documentation is complete, accurate, and readily accessible for audits and reviews.

5) Abbreviations, if any

QA: Quality Assurance
QC: Quality Control
PO: Purchase Order
LIMS: Laboratory Information Management System

6) Documents, if any

Packaging Material Specification Sheets, Certificates of Compliance, Purchase Orders, Sampling Plans, Test Result Records, Discrepancy Reports

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), and ICH Q10 (Pharmaceutical Quality System)

8) SOP Version

Version 1.0