Capsule: SOP for Monitoring Capsule Thickness During Drying – V 2.0

Auditor

6 days ago

Standard Operating Procedure for Monitoring Capsule Thickness During Drying

Department	Capsule Manufacturing
SOP No.	SOP/CM/089/2025
Supersedes	SOP/CM/089/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for monitoring the thickness of capsules during the drying process. Proper monitoring ensures that capsules meet the required specifications for uniformity and quality, preventing issues such as cracking or instability during storage.

2. Scope

This SOP applies to all capsules produced in the manufacturing process that require drying. It covers the monitoring of capsule thickness during the drying stage to ensure the final product meets the established quality standards.

3. Responsibilities

Production Operators: Responsible for conducting regular checks of capsule thickness during drying and adjusting parameters as needed to maintain uniformity.
Quality Control (QC) Team: Ensures that capsule thickness measurements are accurately recorded and that any deviations are addressed. The QC team also verifies that the drying process is in compliance with GMP guidelines.
Quality Assurance (QA) Team: Ensures that the SOP is followed and monitors the overall consistency and compliance with regulatory standards for capsule thickness.
Production Supervisor: Oversees the monitoring process and ensures that all checks are carried out at appropriate intervals, and corrective actions are taken when necessary.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the monitoring of capsule thickness during the drying process is performed consistently and in compliance with this SOP. The QA Manager is responsible for reviewing the documentation and approving the final product batch.

5. Procedure

5.1 Preparation for Monitoring Capsule Thickness

Before monitoring the capsule thickness during drying, ensure the following preparations are made:

Ensure Drying Equipment is Set Up Properly
1. Verify that the drying equipment (e.g., fluidized bed dryer, tray dryer, or oven) is properly set up and calibrated according to the product requirements.
2. Ensure that temperature, humidity, and airflow parameters are within the acceptable range for drying the capsules.
Prepare Measuring Instruments
1. Ensure that all thickness measuring instruments, such as calipers or automated measurement systems, are calibrated and functioning properly.
2. Confirm that the measurement instruments are clean and free from any contaminants that could affect the readings.
Prepare Documentation
1. Ensure that the Capsule Thickness Monitoring Log (Annexure-1) is ready for recording measurements and observations during the drying process.

5.2 Monitoring Capsule Thickness

Monitor capsule thickness during the drying process as follows:

Determine Monitoring Interval
1. Determine the frequency of thickness checks based on the drying time and the product specifications. Typically, thickness should be checked at regular intervals (e.g., every 10 minutes) during the drying process.
Measure Capsule Thickness
1. At the designated interval, randomly select a sample of capsules from the drying batch and measure the thickness of each capsule using the calibrated measuring instrument.
2. Record the measurements in the Capsule Thickness Monitoring Log (Annexure-1).
Check for Uniformity
1. Ensure that the measured thickness is within the acceptable range for the batch. If any capsules fall outside the specified thickness range, investigate the cause and take corrective action if necessary.
Adjust Drying Parameters if Needed
1. If the thickness measurements indicate that the capsules are too thick or too thin, adjust the drying parameters (e.g., temperature, airflow, or humidity) accordingly to achieve uniformity.

5.3 Verifying Capsule Thickness

Once the measurements are taken, verify the results as follows:

Cross-Check Measurements
1. Verify that the recorded thickness measurements match the expected range for the product batch.
2. If any measurements deviate from the expected range, perform additional checks to ensure accuracy.
Document the Measurements
1. Record all measurements and observations in the Capsule Thickness Monitoring Log. Include any corrective actions taken and any adjustments made to the drying parameters.
2. Ensure that the log is signed by the operator conducting the checks and the QC personnel verifying the measurements.

5.4 Corrective Actions for Deviations

If deviations in capsule thickness are detected, take the following corrective actions:

Investigate the Cause
1. Investigate possible causes for the deviations, including equipment malfunction, incorrect drying parameters, or variations in raw materials.
Implement Corrective Actions
1. If the cause of the deviation is identified, implement corrective actions such as adjusting the drying parameters, repairing the equipment, or replacing defective materials.
Monitor Progress
1. Continue to monitor the capsule thickness after the corrective actions have been implemented. Perform additional checks to ensure that the capsules are within the desired thickness range.

5.5 Final Approval and Documentation

Once the capsules meet the desired thickness specifications, the following steps must be completed:

Final Inspection
1. Perform a final inspection of the capsules to confirm that the thickness is uniform and meets the product specifications.
Sign-Off
1. The QC team should sign off on the Capsule Thickness Monitoring Log, confirming that the thickness is within the acceptable range.
Prepare for Packaging
1. Once the thickness has been verified and approved, the capsules can proceed to the next stage of production, including packaging.

5.6 Handling Deviations During Drying

If any deviations are detected during the drying process that could affect capsule thickness, the following steps should be followed:

Document Deviations
1. Any deviations from the expected thickness should be documented in the deviation log, and appropriate corrective actions should be taken.
Investigate Root Cause
1. Investigate the root cause of the deviation, such as incorrect drying time, equipment malfunction, or material variability.
Take Corrective Actions
1. Adjust the drying parameters or equipment settings to resolve the issue and prevent further deviations.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
BPR: Batch Production Record

7. Documents

Capsule Thickness Monitoring Log (Annexure-1)
Deviation Log (Annexure-2)
Corrective Action Report (CAPA) (Annexure-3)

8. References

USP <1163> – Pharmaceutical Dosage Forms: Capsules
FDA Guidelines for Capsule Manufacturing
International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing
Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Capsule Thickness Monitoring Log

Batch ID	Capsule Thickness (mm)	Time of Measurement	Operator Name	Approval Status
Batch 001	0.5	10:00 AM	John Doe	Approved

Annexure-2: Deviation Log

Deviation ID	Description	Corrective Action Taken	Operator Name	Approval Status
DEV-001	Inconsistent capsule thickness	Adjusted drying temperature	Jane Smith	Approved

Annexure-3: Corrective Action Report (CAPA)

CAPA ID	Root Cause	Corrective Action	Preventive Action	Completion Date	Approval Status
CAPA-001	Incorrect drying parameters	Revised drying settings	Routine calibration of drying equipment	02/02/2025	Approved

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 monitoring and corrective actions	Standardization	QA Head