Standard Operating Procedure for Automated Granule Sampling in Continuous Manufacturing
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/170/2025 |
| Supersedes | SOP/TAB/170/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for automated granule sampling during the continuous manufacturing process of tablets, ensuring representative and accurate sampling for quality control and process monitoring.
2. Scope
This SOP applies to the automated granule sampling process in continuous tablet manufacturing, ensuring that granules are sampled at predetermined intervals and meet quality specifications for further processing.
3. Responsibilities
- Production Operator: Responsible for ensuring that the automated granule sampling system is functioning correctly and performing periodic checks to verify sample collection.
- Quality Control (QC): Responsible for reviewing granule samples, analyzing their quality, and ensuring that they meet the required specifications before further processing.
- Quality Assurance (QA): Ensures that the automated granule sampling process is performed according to this SOP and reviews documentation for compliance with GMP standards.
4. Accountability
The Production Supervisor is accountable for ensuring that the automated granule sampling process is carried out according to this SOP. The QC Manager is responsible for verifying the accuracy of the samples and ensuring that they meet quality specifications.
5. Procedure
5.1 Preparation for Automated Granule Sampling
- Ensure that the continuous manufacturing line is set up and operating as per the batch record, with all necessary materials (API, excipients) available for the granulation process.
- Verify that the automated sampling equipment is correctly installed, calibrated, and functioning according to the manufacturer’s specifications.
- Review the batch record to confirm the sampling intervals, number of samples required, and the type of tests that will be conducted on the samples.
- Ensure that all necessary sampling tools, containers, and sample identification labels are available and properly labeled for tracking purposes.
5.2 Automated Sampling Process
- Start the continuous manufacturing process according to the established procedure, ensuring that the granules are produced and conveyed through the automated sampling system.
- The automated sampling system will collect granule samples at predefined intervals as determined by the batch record.
- Monitor the sampling process to ensure that the automated system is collecting samples accurately and at the correct intervals.
- Check the collected samples for consistency and ensure that they are representative of the entire batch.
- If any issues with the automated sampling process are observed, stop the process, investigate the problem, and resolve it before continuing.
5.3 Verifying Sample Quality
- Once the samples are collected, they must be analyzed for key quality attributes, including granule size, moisture content, and uniformity.
- QC will review the sample quality and determine whether the granules meet the required specifications for further processing.
- If the sample quality passes the specified tests, proceed with the next stage in the manufacturing process. If the samples do not meet the specifications, document the failure in the batch record and initiate corrective actions.
5.4 Corrective Actions for Sampling Deviations
- If any deviations are observed during the automated granule sampling process, such as incorrect sample collection intervals, improper sampling equipment performance, or poor sample quality, corrective actions must be taken.
- Corrective actions may include:
- Re-calibrating the automated sampling system to ensure proper sample collection.
- Adjusting the sampling intervals based on process requirements.
- Replacing or repairing malfunctioning sampling equipment.
- After implementing corrective actions, verify the results by collecting and testing new samples to ensure compliance with the required specifications.
- Document all corrective actions taken in the deviation report (Annexure-1), and ensure that they are reviewed by the QA team before proceeding with the next steps in the process.
5.5 Acceptance Criteria
- The batch is considered acceptable if the granule samples meet the quality specifications for size, moisture content, and uniformity, and if the sampling process is performed according to the batch record.
- If the granule samples fail to meet the quality specifications, the batch may need to be adjusted or reworked, and further corrective actions must be taken.
5.6 Post-Sampling Actions
- Once the granules have been sampled and the results have been reviewed, document the results in the batch record and store the samples appropriately for further analysis if needed.
- Ensure that all records related to the automated granule sampling process, including test results and corrective actions, are completed and stored according to the company’s document retention policy.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
- CAPA: Corrective and Preventive Action
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Granule and Powder Sampling Guidelines
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Sampling and Testing for Granulation
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Automated sampling system malfunction | Recalibrated system and re-sampled granules | John Doe |
Annexure-2: Batch Record
| Sample Number | Granule Quality Test Result | Tested By |
|---|---|---|
| Sample 1 | Pass – Size 4mm, Moisture 3% | Jane Smith |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated sampling intervals | Improved sampling process | QA Head |