Capsule: SOP for Conducting Randomized Sampling of Capsules – V 2.0

Auditor

4 days ago

Standard Operating Procedure for Conducting Randomized Sampling of Capsules

Department	Capsule Manufacturing
SOP No.	SOP/CM/104/2025
Supersedes	SOP/CM/104/2022
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 establish a standardized procedure for conducting randomized sampling of capsules. Randomized sampling ensures that the samples collected are representative of the entire batch, allowing for accurate quality control testing and ensuring the final product meets all quality specifications.

2. Scope

This SOP applies to the process of random sampling during the capsule manufacturing process. It covers the selection, collection, and handling of samples from the production batch for quality control testing.

3. Responsibilities

Production Operators: Responsible for following the sampling procedure to collect samples from the production batch and ensuring proper labeling.
Quality Control (QC) Team: Responsible for overseeing the randomized sampling process, ensuring the proper collection of samples, and conducting the necessary tests on the samples.
Quality Assurance (QA) Team: Ensures that the sampling process is conducted according to the SOP and reviews the testing results to ensure that the batch meets quality specifications.
Production Supervisor: Oversees the entire sampling process, ensures that proper sampling procedures are followed, and resolves any issues that arise during the sampling process.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the randomized sampling is conducted according to this SOP. The QA Manager is responsible for reviewing and approving the sampling process and ensuring that the results are in compliance with quality standards.

5. Procedure

5.1 Sample Size Determination

Before collecting samples, determine the sample size based on the following:

Determine Sample Size
1. Calculate the appropriate sample size based on batch size, the expected variability of the product, and the level of confidence required for the testing.
2. Consult standard sampling tables or quality control guidelines to determine the minimum number of samples required for the batch size.
Confirm Sampling Requirements
1. Ensure that the sample size is representative of the entire batch and that all critical quality attributes (e.g., size, weight, fill volume, appearance) will be covered in the sampling process.
2. Ensure that the sampling plan adheres to industry standards or regulatory requirements for randomized sampling.

5.2 Randomized Sampling Process

Follow these steps to ensure that sampling is conducted randomly and represents the entire production batch:

Ensure Random Selection
1. Choose capsules randomly from different stages of the manufacturing process, ensuring that the selected capsules are representative of the entire batch.
2. Do not select samples based on visual appearance to avoid selection bias.
Collect the Samples
1. Use clean and properly labeled sampling containers to collect the samples. Ensure that the capsules are not contaminated during the sampling process.
2. Collect the samples from different locations in the batch, ensuring that they represent the entire manufacturing run.
Record Sample Information
1. Label each sample with the batch number, sampling time, and location. Ensure that the samples are stored in a clean, secure area until testing.
2. Document all relevant details in the Sample Collection Log (Annexure-1), including the operator’s name, the time of sampling, and any other relevant observations.

5.3 Quality Control Testing

Once the samples have been collected, the following steps must be followed to test the capsules for compliance:

Test the Samples
1. QC will perform the necessary tests on the samples to evaluate the critical quality attributes, such as size, weight, fill volume, and appearance.
2. Tests should be performed according to the predefined specifications for the capsules, ensuring that they meet the required standards.
Analyze Test Results
1. Analyze the test results to determine whether the capsules meet the established quality standards.
2. If the results are within acceptable limits, the batch is deemed to pass the randomized sampling test and can proceed to the next stage of production.
3. If the results are outside the acceptable limits, identify the cause of the deviation and take corrective actions.
Document the Results
1. Document all test results, including any deviations found, in the Sampling and Testing Report (Annexure-2).
2. Ensure that all documentation is reviewed and signed by the responsible QC team member.

5.4 Handling Deviations and Corrective Actions

If the sampled capsules do not meet the quality specifications, follow these steps:

Identify the Cause of Deviation
1. Investigate the root cause of the deviation by reviewing the manufacturing process, materials, and equipment used during production.
2. Consult with the production team to determine if any environmental factors, machine settings, or raw material issues contributed to the deviation.
Implement Corrective Actions
1. Take corrective actions, such as adjusting equipment settings, modifying the process, or addressing raw material issues, to prevent recurrence of the deviation.
2. Retest the batch or affected samples after corrective actions are implemented to confirm that the issue has been resolved.
Document the Deviation and Corrective Actions
1. Record all deviations and corrective actions in the Deviation Log (Annexure-3) for future reference and regulatory compliance.

5.5 Final Approval and Release

Once the randomized sampling has been completed and any necessary corrective actions have been taken, the following steps must be taken:

QA Review
1. The QA team reviews the sampling results and corrective actions taken, ensuring that the batch meets the required quality specifications.
Approval for Next Stage
1. If the batch passes the randomized sampling and testing, the batch is approved for the next stage of production or packaging.

6. Abbreviations

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

7. Documents

Sample Collection Log (Annexure-1)
Sampling and Testing Report (Annexure-2)
Deviation Log (Annexure-3)

8. References

USP <1163> – Pharmaceutical Dosage Forms: Capsules
FDA Guidelines for Capsule 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: Sample Collection Log

Sample ID	Sample Location	Sample Time	Collected By	Batch ID
Sample 001	Line 1	10:00 AM	John Doe	Batch 001
Sample 002	Line 2	10:15 AM	Jane Smith	Batch 001

Annexure-2: Sampling and Testing Report

Sample ID	Test Parameter	Test Result	Deviations	Corrective Action
Sample 001	Capsule Weight	500 mg	No	None
Sample 002	Fill Volume	Standard	No	None

Annexure-3: Deviation Log

Deviation ID	Batch ID	Description	Corrective Action	Operator	Approval Status
DEV-001	Batch 001	Capsule weight outside acceptable range	Recalibrated machine	John Doe	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 sampling procedures and documentation	Standardization	QA Head