Procedures for Inspecting and Releasing Raw Materials

1) Purpose

The purpose of this SOP is to establish procedures for inspecting and releasing raw materials for use in manufacturing based on predefined criteria to ensure quality and compliance.

2) Scope

This SOP applies to all raw materials received and used in the pharmaceutical manufacturing process.

3) Responsibilities

The Quality Control (QC) department is responsible for inspecting raw materials. The Quality Assurance (QA) department is responsible for releasing materials based on inspection results.

4) Procedure

1. Receiving and Inspection:
   1. Upon receipt, check the raw materials for any visible damage or discrepancies in labeling.
   2. Record details such as supplier name, batch number, and quantity in the raw material logbook.
2. Sampling and Testing:
   1. Follow the sampling procedure to collect representative samples from the received materials.
   2. Conduct necessary tests to ensure materials meet predefined quality specifications.
   3. Document the results of all tests performed.
3. Review and Release:
   1. QA department reviews the test results and verifies compliance with quality specifications.
   2. If the material meets all criteria, approve and release it for use in manufacturing.
   3. Record the release decision in the raw material logbook and update the inventory system.
4. Handling Non-Conforming Materials:
   1. If the material does not meet quality specifications, document the non-conformance and notify the supplier.
   2. Quarantine the non-conforming material and conduct an investigation to determine the cause.
   3. Decide on appropriate actions such as return, rework, or disposal, and document the decision.

5) Abbreviations, if any

QC: Quality Control

QA: Quality Assurance

6) Documents, if any

Raw Material Logbook, Test Result Records, Release Forms, and Non-Conformance Reports

7) Reference, if any

Relevant regulatory guidelines such as ICH Q7 and FDA Guidance for Industry

8) SOP Version

Version 1.0