Standard Operating Procedure for Batch-to-Batch Consistency Monitoring in Granulation

Department	Tablet
SOP No.	SOP/TAB/148/2025
Supersedes	SOP/TAB/148/2022
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 monitoring and ensuring batch-to-batch consistency during the granulation process in tablet manufacturing. This ensures uniformity in the quality and characteristics of tablets across multiple batches.

2. Scope

This SOP applies to the granulation process in tablet production, ensuring that consistency is maintained from batch to batch, including particle size, moisture content, and uniformity of granules.

3. Responsibilities

• Quality Control (QC): Responsible for monitoring the consistency of granulation across batches through sampling and testing for key parameters such as particle size and moisture content.
• Granulation Operator: Responsible for ensuring that the granulation process follows the prescribed parameters and that samples are taken at specified intervals for consistency testing.
• Quality Assurance (QA): Ensures compliance with the SOP, reviews consistency data, and approves any corrective actions or deviations.

4. Accountability

The QC Manager is accountable for ensuring that batch-to-batch consistency is monitored throughout the granulation process. The QA Manager is responsible for reviewing and approving any necessary corrective actions or adjustments.

5. Procedure

5.1 Sampling

1. During each granulation process, collect representative samples at defined intervals (e.g., after every 100 kg or batch).
2. Ensure that the samples represent the entire batch and are handled according to the sampling procedure outlined in the relevant SOP.

5.2 Key Parameters for Consistency Monitoring

1. Monitor the following key parameters during each batch of granulation:
   • Particle size distribution
   • Moisture content
   • Uniformity of granules

5.3 Performing Tests

1. Perform particle size analysis using an appropriate method (e.g., sieve analysis, laser diffraction) to check consistency with previous batches.
2. Check moisture content using a moisture analyzer or oven-drying method, ensuring it remains within the specified range.
3. Test granule uniformity by evaluating the consistency of granule size and distribution. Record all results accurately.

5.4 Documentation and Records

1. Document the results of all tests in the batch record (Annexure-2) and note any deviations from the established specifications.
2. If any deviation is detected, generate a deviation report (Annexure-1) and investigate the root cause.

5.5 Corrective Actions

1. If batch-to-batch consistency falls outside the acceptable limits, take corrective actions such as adjusting the granulation process, reformulating, or modifying process parameters.
2. Document the corrective actions taken and verify the effectiveness of the adjustments through subsequent batch monitoring.

5.6 Post-Testing Actions

1. If the batch-to-batch consistency is maintained, proceed with the subsequent tablet manufacturing steps such as compression and coating.
2. If inconsistencies are found, review the process and implement the corrective actions required, including additional testing or reworking of the batch.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• Moisture Content: The amount of water present in the granules
• Particle Size Distribution: The distribution of particle sizes within the granules

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• USP <701> – Granulation and Moisture Testing for Tablets
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Granulation Specifications for Tablets

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	Particle size exceeded the required range	Reworked the batch and adjusted granulation process	John Doe

Annexure-2: Batch Record

Sample Number	Particle Size	Moisture Content	Uniformity Test Result	Action Taken
Sample 1	100 µm	3.5%	Pass	Accepted

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 consistency monitoring process	Process optimization	QA Head