Standard Operating Procedure for Raw Material Inspection for Granules

1) Purpose

The purpose of this SOP is to define the procedures for the inspection and testing of raw materials used in granules production within the pharmaceutical industry to ensure quality, safety, and compliance with specifications.

2) Scope

This SOP applies to all personnel involved in the inspection and testing of raw materials used for granules production within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting inspections and tests on raw materials.
Procurement Department: Responsible for ensuring raw materials meet specifications before acceptance.
Production Supervisors: Responsible for coordinating with QC and procurement departments for timely material inspection.

4) Procedure

1. Receipt and Sampling:
   1. Receive raw materials in designated receiving areas.
   2. Take representative samples for testing based on sampling plans.
2. Visual Inspection:
   1. Conduct visual inspection for any damages, contamination, or discrepancies in packaging.
   2. Document findings and notify procurement or QC department for further action if needed.
3. Identity Testing:
   1. Verify the identity of raw materials using appropriate testing methods (e.g., FTIR, HPLC).
   2. Compare test results against reference standards or specifications.
4. Quality Testing:
   1. Perform quality tests such as assay, impurities, particle size, and moisture content as per specifications.
   2. Record test results accurately and ensure compliance with acceptance criteria.
5. Release or Rejection:
   1. Make disposition decisions based on inspection and testing results.
   2. Label materials as approved, rejected, or pending retest as appropriate.
6. Documentation:
   1. Maintain comprehensive records of raw material inspections and testing activities.
   2. Archive records according to document control procedures and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
FTIR: Fourier Transform Infrared Spectroscopy
HPLC: High-Performance Liquid Chromatography

6) Documents, if any

Raw Material Specifications, Sampling Plans, Test Procedures

7) Reference, if any

Pharmacopeial monographs, internal specifications, and regulatory guidelines.

8) SOP Version

Version 1.0