Standard Operating Procedure for Granulation Process for Immediate Release Tablets

Department	Tablet
SOP No.	SOP/TAB/001/2025
Supersedes	SOP/TAB/001/2022
Page No.	Page 1 of 10
Issue Date	15/02/2025
Effective Date	20/02/2025
Review Date	15/02/2026

1. Purpose

To establish the granulation process for immediate release tablets, ensuring uniformity, stability, and compliance with GMP requirements.

2. Scope

This SOP applies to the granulation of immediate release tablets, covering raw material handling, equipment setup, and granule preparation.

3. Responsibilities

• Manufacturing Personnel: Follow instructions for equipment setup, material handling, and process execution.
• QC: Conduct in-process checks and ensure the granules meet quality specifications.
• QA: Ensure compliance with SOP and review batch records for approval.

4. Accountability

The Production Manager is responsible for implementation; the QA Manager ensures compliance and approval.

5. Procedure

5.1 Receiving and Preliminary Inspection

1. Inspect all raw materials upon receipt.
2. Verify packaging, labeling, and documentation such as Certificates of Analysis (CoA).
3. Store materials under specified conditions.

5.2 Equipment Setup

1. Inspect and calibrate the granulation equipment, including the mixer and dryer.
2. Ensure all instruments (e.g., moisture analyzers, sieves) are in working order.

5.3 Granulation Process

1. Load the dry powder mixture (API and excipients) into the granulator.
2. Prepare and add the binder solution to the powder mixture while stirring continuously.
3. Granulate the mixture until the desired granule size is achieved. Adjust parameters like speed, time, and binder addition based on the material’s response during the process.
4. Ensure uniform wetting of the powder blend to form uniform granules. Continue mixing until the mixture reaches the required consistency, as per the formulation specifications.
5. Verify the process by monitoring granule size using a sieve or particle size analyzer. Continue adjusting as necessary to ensure uniformity.

5.4 Screening and Drying

1. Screen the granulated mixture to ensure uniformity of granule size. Discard oversized or undersized granules.
2. Dry the granules in the fluidized bed dryer, checking moisture content regularly with a moisture analyzer to achieve the desired moisture level.

5.5 Final Quality Control

1. Perform particle size distribution analysis and moisture content tests on the granules.
2. Ensure granules meet the required quality specifications for use in tablet compression.
3. Take necessary corrective actions if any parameters fall outside acceptable limits.

5.6 Documentation and Record-Keeping

1. Record all process parameters in the batch record, including mixing times, binder amounts, and granule characteristics.
2. Log in-process checks and test results in the QC Log (Annexure-1), ensuring traceability of all batch details.
3. Maintain batch records for reference during future production runs or audits.

6. Abbreviations

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

7. Documents

1. Granulation Batch Record (Annexure-1)
2. Granule Quality Control 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: Granulation Batch Record

Batch Number	Material Name	Binder Solution	Granulation Parameters	Test Results	Remarks
Batch 001	Material A	Starch Solution	Mixing Time: 30 mins, Speed: 250 rpm	Moisture: 4.5%, Size Distribution: 80% < 500 µm	Within Specifications
Batch 002	Material B	PVP Solution	Mixing Time: 40 mins, Speed: 300 rpm	Moisture: 5.2%, Size Distribution: 75% < 500 µm	Minor Deviations

Annexure-2: Granule Quality Control Log

Batch Number	Test Performed	Result	Test Date	QC Personnel
Batch 001	Particle Size	Pass	15/02/2025	John Doe
Batch 002	Moisture Content	Pass	16/02/2025	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 Parameters	Standardization of Granulation Process	QA Head