Standard Operating Procedure for Raw Material Quality Assurance

1) Purpose

This SOP outlines the procedures for ensuring the quality of raw materials used in pharmaceutical manufacturing to comply with regulatory standards and internal quality requirements.

2) Scope

This SOP applies to all raw materials received, tested, and used in the production 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 raw materials meet specified quality criteria before use in manufacturing.

4) Procedure

4.1 Receiving Raw Materials

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

4.2 Sampling and Testing

1. Collect samples of raw materials as per 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 raw 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 raw materials in designated areas under controlled conditions.
2. Ensure that raw materials are properly labeled with identification numbers, status (accepted/rejected), and expiration dates.
3. Handle all raw materials following the company’s safety and handling guidelines.

4.5 Documentation and Records

1. Maintain all records of raw 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
COA: Certificate of Analysis
PO: Purchase Order
LIMS: Laboratory Information Management System

6) Documents, if any

Raw Material Specification Sheets, Certificates of Analysis, 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)

8) SOP Version

Version 1.0