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
- Sampling:
- Collect representative samples of granules at specified stages of production.
- Ensure samples are taken in accordance with defined sampling plans.
- Testing Procedures:
- Perform testing for critical quality attributes such as particle size distribution, moisture content, and bulk density.
- Use validated test methods and calibrated equipment for accurate results.
- Data Analysis:
- Analyze test results against predefined acceptance criteria.
- Document all results accurately and legibly.
- Result Reporting:
- Report test results promptly to production personnel for decision-making.
- Document results in batch records or electronic systems as per SOPs.
- Documentation:
- Maintain complete records of in-process testing activities, including test protocols, results, and any deviations.
- Archive records in accordance with document control procedures and regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
Sampling Plan, Test Method Validation Reports, In-process Testing Records
7) Reference, if any
Good Manufacturing Practice (GMP) guidelines for pharmaceutical manufacturing.
8) SOP Version
Version 1.0