Standard Operating Procedure for Final Product Inspection for Granules

1) Purpose

The purpose of this SOP is to define procedures for conducting final product inspection of granules in the pharmaceutical industry to ensure compliance with quality standards and specifications before release.

2) Scope

This SOP applies to all personnel involved in final product inspection activities for granules within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing final product inspection and releasing materials based on inspection results.
Production Supervisors: Responsible for coordinating final inspection activities.
Operators and Technicians: Responsible for assisting in the inspection process and documenting results.

4) Procedure

1. Sampling:
   1. Select random samples of finished granules batches according to sampling plan.
   2. Ensure samples are representative and properly labeled.
2. Inspection Criteria:
   1. Verify physical characteristics such as color, appearance, and uniformity of granules.
   2. Perform tests for critical quality attributes such as assay, particle size distribution, and moisture content.
3. Documentation:
   1. Record inspection results accurately in batch records or electronic systems.
   2. Document any deviations or discrepancies found during inspection.
4. Decision Making:
   1. Compare inspection results against predefined acceptance criteria.
   2. Make decisions on batch disposition (release, reject, or rework) based on inspection findings.
5. Approval and Release:
   1. Submit inspection results and documentation to QA for review and approval.
   2. Release conforming batches for further processing or distribution.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Sampling Plan, Batch Records, Inspection Reports

7) Reference, if any

Good Manufacturing Practice (GMP) guidelines for pharmaceutical manufacturing.

8) SOP Version

Version 1.0