Standard Operating Procedure for Process Controls in Sustained Release Tablet Manufacturing

Department	Tablet
SOP No.	SOP/TAB/017/2025
Supersedes	SOP/TAB/017/2022
Page No.	Page 1 of 9
Issue Date	04/05/2025
Effective Date	09/05/2025
Review Date	04/05/2026

1. Purpose

This SOP outlines the process controls required for the manufacture of sustained release tablets, ensuring consistent release profiles, stability, and compliance with product specifications.

2. Scope

This SOP applies to the manufacturing process of sustained release tablets, covering formulation, equipment setup, process monitoring, and in-process testing during production.

3. Responsibilities

• Manufacturing Personnel: Responsible for following process parameters, ensuring proper setup, and executing the sustained release tablet production process.
• Quality Control (QC): Responsible for testing and verifying that the sustained release tablets meet the required specifications for drug release, hardness, and other relevant characteristics.
• Quality Assurance (QA): Ensures that the manufacturing process adheres to GMP standards, reviews records for compliance, and addresses any deviations from specifications.

4. Accountability

The Production Manager is accountable for ensuring that the sustained release tablet manufacturing process is executed according to this SOP. The QA Manager is responsible for ensuring regulatory compliance and approving any corrective actions.

5. Procedure

5.1 Formulation of Sustained Release Tablets

1. Ensure that all raw materials, including active pharmaceutical ingredients (APIs), excipients, and controlled release agents, meet the specifications and are within their expiration dates.
2. Weigh and prepare excipients, ensuring that the correct ratios are used to achieve the desired release profile for the tablet.
3. Use appropriate binder systems to achieve the desired mechanical strength and sustained release characteristics.
4. Ensure that the formulation is homogeneous before proceeding with the manufacturing process.

5.2 Tablet Compression Setup

1. Verify that the tablet compression machine is calibrated and set to the required parameters, including compression force, tablet size, and tablet weight.
2. Check that the tablet tooling is correctly installed and free from defects or wear.
3. Ensure that the tablet press machine is clean and free of any residues from previous batches, and follow the equipment cleaning SOP.

5.3 Compression of Sustained Release Tablets

1. Load the pre-blended material into the hopper of the tablet press machine.
2. Set the compression force according to the product specifications. The compression force should be sufficient to produce tablets with the required hardness without compromising the release profile.
3. Compress the tablet mixture under controlled conditions, monitoring for uniformity in tablet weight, hardness, and thickness.
4. Periodically check for any signs of irregularities in tablet appearance or texture, such as cracking or breaking.

5.4 In-Process Monitoring

1. During the compression process, perform regular checks to ensure that tablet weight, hardness, and dimensions remain within the acceptable limits.
2. Monitor tablet hardness using a hardness tester, ensuring that the tablets meet the minimum strength requirements for sustained release tablets.
3. Perform weight variation checks every 30 minutes to ensure that tablets are consistently produced with the correct weight.
4. Ensure uniformity in tablet dimensions, with no variation that could impact the release characteristics.
5. Record the results of all in-process quality control checks in the batch record (Annexure-1).

5.5 Drug Release Profile Testing

1. Once the tablets are compressed, conduct a drug release test to ensure that the sustained release profile meets the required specifications.
2. Use a dissolution tester to measure the release of the active ingredient over a set period. The release rate should follow the predetermined profile set for sustained release tablets.
3. Perform dissolution testing at specified time intervals (e.g., 1 hour, 2 hours, 4 hours, etc.) to verify that the release is within the acceptable range.
4. Record all dissolution testing data and ensure that the results are within the established limits for sustained release tablets.

5.6 Final Inspection

1. After compression and testing, perform a final inspection of the tablets to verify that they meet all physical and release profile specifications.
2. Ensure that the tablets are free from defects such as cracking, chipping, or discoloration.
3. Verify that the tablets meet the release profile based on the dissolution test results.

5.7 Packaging and Storage

1. Once the sustained release tablets pass all quality checks, they should be packaged in suitable containers to protect them from moisture and light, which could affect their release profile.
2. Ensure that the tablets are stored in a controlled environment with proper temperature and humidity levels to maintain their stability.
3. Label the containers clearly with batch details, expiry dates, and storage instructions.

5.8 Equipment Shutdown and Cleaning

1. After the compression process is completed, shut down the equipment and clean it according to the cleaning SOP to prevent cross-contamination.
2. Ensure that all components that came into contact with the sustained release tablet material (e.g., tablet press, tooling) are thoroughly cleaned and sanitized.
3. Document all cleaning activities in the equipment cleaning log (Annexure-2) and ensure compliance with regulatory requirements.

5.9 Documentation and Record-Keeping

1. Document all process parameters, including formulation, equipment settings, in-process checks, and test results, in the batch record.
2. Ensure that all records are reviewed, signed off, and stored for regulatory compliance and future reference.
3. Document any deviations from the standard process and corrective actions taken during the production process.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-1)
2. Equipment Cleaning Log (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Type	Compression Force	Tablet Weight	Release Profile	Remarks
Batch 001	Tablet A	500 N	500 mg	Within specifications	Approved
Batch 002	Tablet B	520 N	505 mg	Deviation corrected	Approved

Annexure-2: Equipment Cleaning Log

Equipment	Cleaning Date	Cleaning Method	Personnel
Tablet Press	03/05/2025	Washing with detergent and rinsing with water	John Doe
Tablet Press	04/05/2025	Washing with detergent and rinsing with water	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 Process Controls	Optimization of Tablet Manufacturing Process	QA Head