Standard Operating Procedure for Weighing Excipients for Capsule Formulations

Department	Capsule Manufacturing
SOP No.	SOP/CM/005/2025
Supersedes	SOP/CM/005/2022
Page No.	Page 1 of 8
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

To define the procedure for weighing excipients used in capsule formulations to ensure accurate measurements, maintain product quality, and comply with GMP standards.

2. Scope

This SOP applies to all excipients used in the preparation of capsule formulations. It covers the process of weighing, handling, and transferring excipients from storage to the formulation area.

3. Responsibilities

• Manufacturing Personnel: Responsible for weighing excipients accurately and ensuring the proper handling of materials.
• Quality Control (QC) Team: Responsible for verifying the weight of excipients and confirming their quality before use in the formulation process.
• Warehouse Personnel: Responsible for transferring the excipients to the manufacturing area in a safe and timely manner.
• Quality Assurance (QA) Team: Ensures overall compliance with GMP standards and monitors the weighing process to ensure consistency and accuracy.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring the proper weighing of excipients. The QA Manager is responsible for overseeing compliance with GMP and regulatory standards.

5. Procedure

5.1 Preparation for Weighing

Before weighing excipients, ensure the following steps are completed:

1. Verify Material
   1. Check that the correct excipient is selected based on the batch record and work order.
   2. Verify the excipient’s batch number and expiry date from the Certificate of Analysis (CoA) and other documentation to ensure compliance with quality standards.
2. Prepare the Weighing Equipment
   1. Ensure that the weighing scale is calibrated and free from any residue from previous weighings.
   2. Verify that all necessary tools (e.g., scoops, containers, spatulas) are clean and ready for use.
   3. Ensure the weighing area is clean and free of contaminants.
3. Check Environmental Conditions
   1. Ensure that the temperature and humidity in the weighing area are within the required range to prevent material degradation or weighing errors.
   2. Ensure that the weighing area is free from drafts or vibrations that may affect the accuracy of the balance.

5.2 Weighing Excipients

Follow these steps for accurate weighing of excipients:

1. Weighing Procedure
   1. Place a clean container or weighing boat on the scale and tare it to zero.
   2. Weigh the excipient to the specified quantity, ensuring accuracy and precision.
   3. If the excipient is in bulk form, use a clean scoop to transfer the material to the container, avoiding contamination.
   4. After weighing, record the exact weight of the excipient to ensure traceability.
2. Recheck Weighed Amount
   1. If the weight is not within the acceptable range, repeat the weighing process until the correct weight is obtained.
   2. Document any deviations from the specified weight, and notify the QA team for further action if necessary.

5.3 Handling and Transferring Excipients

After weighing, follow these steps to safely handle and transfer excipients:

1. Transfer to Dispensing Container
   1. Carefully transfer the weighed excipient into the dispensing container, ensuring that no material is lost during the transfer process.
   2. If handling multiple excipients, ensure that they are dispensed separately and clearly labeled to prevent mix-ups.
2. Labeling the Dispensed Excipients
   1. Ensure that the dispensing container is labeled with the excipient name, batch number, weight, and dispensing date.
   2. Record the weight of the excipient in the Material Dispensing Log (Annexure-1) along with other relevant details, such as the work order and personnel involved in dispensing.

5.4 Storage of Weighed Excipients

Once the excipients are weighed, store them properly to maintain their quality:

1. Storage Conditions
   1. Store the dispensed excipient in the appropriate storage conditions as outlined in the product specifications (e.g., cool, dry storage for sensitive materials).
   2. Ensure that the storage area is clearly labeled and segregated from other materials to prevent cross-contamination.
2. Inventory Management
   1. Update the inventory management system to reflect the dispensed excipient quantity.
   2. Track the usage of dispensed excipients to ensure that the correct amount is used in the capsule formulation process and to monitor stock levels.

5.5 Handling Rejected or Non-Conforming Excipients

If any excipient is found to be non-conforming, follow these steps:

1. Quarantine the Material
   1. Immediately quarantine the excipient and label it as “Rejected” or “Quarantined” to prevent its accidental use.
   2. Notify the QA team and initiate a review of the material.
2. Document the Issue
   1. Complete a Discrepancy Report (Annexure-2) documenting the issue with the excipient, including the reason for rejection or non-conformance.
   2. Coordinate with the Procurement team to return the excipient to the supplier or request a replacement as needed.

5.6 Documentation and Record-Keeping

Ensure proper documentation for all weighing activities:

1. Record the weight of each dispensed excipient in the Material Dispensing Log (Annexure-1) along with all relevant details (e.g., material name, batch number, work order, and personnel involved).
2. Maintain records of rejected or non-conforming excipients in the Discrepancy Report (Annexure-2), including the corrective actions taken.
3. Store all documentation securely for easy retrieval and regulatory compliance.

6. Abbreviations

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

7. Documents

1. Material Dispensing Log (Annexure-1)
2. Discrepancy Report (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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Dispensing Log

Date	Excipients Name	Batch Number	Quantity Dispensed	Responsible Personnel
03/02/2025	Excipent-123	Batch 56789	500 g	Jane Smith

Annexure-2: Discrepancy Report

Date	Excipients Name	Batch Number	Issue Description	Corrective Action
04/02/2025	Excipent-456	Batch 67890	Out of Specification	Returned to Supplier

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	Document Format and Updates	Standardization	QA Head