Standard Operating Procedure for In-process Testing for Granules

1) Purpose

The purpose of this SOP is to define procedures for conducting in-process testing during granules production in the pharmaceutical industry to ensure product quality and compliance with specifications.

2) Scope

This SOP applies to all personnel involved in in-process testing activities for granules production within the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing in-process testing and releasing materials based on test results.
Production Supervisors: Responsible for coordinating sampling and testing during production.
Operators and Technicians: Responsible for assisting in the collection of samples and executing tests as per procedures.

4) Procedure

1. Sampling:
   1. Collect representative samples of granules at specified stages of production.
   2. Ensure samples are taken in accordance with defined sampling plans.
2. Testing Procedures:
   1. Perform testing for critical quality attributes such as particle size distribution, moisture content, and bulk density.
   2. Use validated test methods and calibrated equipment for accurate results.
3. Data Analysis:
   1. Analyze test results against predefined acceptance criteria.
   2. Document all results accurately and legibly.
4. Result Reporting:
   1. Report test results promptly to production personnel for decision-making.
   2. Document results in batch records or electronic systems as per SOPs.
5. Documentation:
   1. Maintain complete records of in-process testing activities, including test protocols, results, and any deviations.
   2. Archive records in accordance with document control procedures and regulatory