Tablets: SOP for Particle Size Analysis in Slow-Release Tablets – V 2.0

Standard Operating Procedure for Particle Size Analysis in Slow-Release Tablets

Department	Tablet
SOP No.	SOP/TAB/086/2025
Supersedes	SOP/TAB/086/2022
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 performing particle size analysis in slow-release tablets, ensuring that the particle size of the active pharmaceutical ingredient (API) and excipients is within the desired range to ensure the intended release profile.

2. Scope

This SOP applies to the particle size analysis of granules and powders used in the manufacture of slow-release tablets to ensure that the particle size distribution meets the specifications required for the formulation and performance of the tablets.

3. Responsibilities

Manufacturing Personnel: Responsible for providing representative samples of granules or powders for particle size analysis and ensuring the proper preparation of these samples.
Quality Control (QC): Responsible for performing the particle size analysis using appropriate analytical methods, recording the results, and ensuring the results meet the specifications.
Quality Assurance (QA): Ensures that the testing procedure is followed and reviews the results to approve or reject the batch for release.

4. Accountability

The QC Manager is accountable for ensuring that particle size analysis is performed in compliance with this SOP and for reporting the results. The QA Manager is responsible for reviewing the results and approving the batch for release.

5. Procedure

5.1 Sample Collection

Collect a representative sample of granules or powders from the batch, as specified in the batch record.
The sample should consist of an appropriate amount of granules or powder (typically 10–20 grams, or as specified in the batch record or pharmacopeial guidelines).
Ensure that the sample is free from defects, contamination, or other visible issues.
Label the sample appropriately for identification during testing.

5.2 Preparation of Particle Size Analysis Apparatus

Ensure that the particle size analysis equipment, such as a sieve shaker, laser diffraction analyzer, or other suitable instruments, is calibrated and functioning properly.
Prepare any required calibration standards or reference materials according to the manufacturer’s instructions and company procedures.

5.3 Performing the Particle Size Analysis

For sieve analysis, weigh the required amount of granules or powder and place them in the sieve stack with the appropriate mesh sizes.
Operate the sieve shaker for the specified time or until the particles have been adequately separated.
For laser diffraction analysis, prepare the sample by dispersing it in an appropriate solvent, ensuring that the sample concentration is within the operating range of the instrument.
For both methods, record the particle size distribution and the percentage of particles falling within the defined size ranges.

5.4 Data Recording and Calculation

Record the particle size distribution data, including the median particle size (D50), the size at 10% (D10), and the size at 90% (D90) of the cumulative distribution, as well as any other relevant parameters.
Ensure that the particle size distribution falls within the specifications set in the batch record or pharmacopeial guidelines (e.g., D50 should be within a specific range for the formulation to ensure proper release characteristics).
Document the calculated results, including any observations, in the batch record (Annexure-1).

5.5 Acceptance Criteria

Ensure that the particle size distribution of the granules or powder meets the required specifications. Typically, the target particle size range will be specified in the batch record or pharmacopeial guidelines, based on the intended dissolution and release profile.
If the particle size distribution does not meet the acceptance criteria, the batch should be investigated, and corrective actions should be documented in the deviation report (Annexure-2).

5.6 Documentation and Record-Keeping

Document the particle size analysis results, including the individual particle size data, the mean particle size, and the distribution profile, in the batch record (Annexure-1).
Record any deviations from the particle size specifications in the deviation report (Annexure-2), along with corrective actions taken.
Ensure all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.7 Post-Test Cleanup

Clean the particle size analysis equipment, including sieves or laser diffraction apparatus, according to the manufacturer’s instructions and the company’s cleaning SOP.
Ensure that all equipment is properly stored and maintained in good working condition for future use.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient
D50: Median particle size
D10: 10th percentile particle size
D90: 90th percentile particle size

7. Documents

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

8. References

USP <786> – Particle Size Distribution
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
European Pharmacopoeia (EP) – Testing for Particle Size

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	Sample Name	Particle Size (D50)	Particle Size (D10)	Particle Size (D90)	Result
Batch 001	Granules	250 µm	150 µm	400 µm	Pass

Annexure-2: Deviation Report

You said:
Continue
ChatGPT said:
Here is the continuation of the SOP for “Particle Size Analysis in Slow-Release Tablets” in HTML format:

html
Copy

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Particle size distribution out of specification	Re-processed granules and adjusted milling process	John Doe

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 Particle Size Testing Parameters	Improved test methodology	QA Head