Standard Operating Procedure for Handling APIs During Dispensing

Department	Capsule Manufacturing
SOP No.	SOP/CM/004/2025
Supersedes	SOP/CM/004/2022
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 handling Active Pharmaceutical Ingredients (APIs) during dispensing in capsule manufacturing to ensure safety, quality, and compliance with GMP standards.

2. Scope

This SOP applies to all APIs used in capsule manufacturing. It covers the process of receiving, handling, and dispensing APIs in a controlled, GMP-compliant manner.

3. Responsibilities

• Dispensing Personnel: Responsible for accurately dispensing APIs, following safety protocols, and ensuring compliance with the SOP.
• Quality Control (QC) Team: Responsible for verifying that the dispensed APIs meet the required quality standards before use in manufacturing.
• Warehouse Personnel: Responsible for ensuring that APIs are stored in the proper conditions and are transferred securely to the dispensing area.
• Quality Assurance (QA) Team: Ensures overall compliance with regulatory and GMP standards for API handling during dispensing.

4. Accountability

The Manufacturing Supervisor is accountable for overseeing the proper dispensing of APIs. The QA Manager ensures that the procedure complies with GMP standards and resolves any deviations.

5. Procedure

5.1 API Receipt and Verification

Follow these instructions when receiving APIs for dispensing:

1. Verify Documentation
   1. Check that each batch of APIs is accompanied by a Certificate of Analysis (CoA) and other relevant documentation (e.g., Safety Data Sheets, batch records).
   2. Ensure that the API received matches the Purchase Order (PO) and that the CoA details correspond with the expected specifications (e.g., purity, identity, potency).
2. Storage Conditions
   1. Ensure that APIs are stored in appropriate conditions (e.g., temperature-controlled rooms, humidity control, or sealed containers) until dispensed.
   2. Ensure that APIs are labeled as “Quarantine” until they are dispensed, tested, and approved for use.

5.2 Dispensing APIs

Follow these steps during the dispensing process:

1. Preparation for Dispensing
   1. Ensure that all dispensing equipment (e.g., balances, scoops, containers) is clean and calibrated.
   2. Review the batch record to ensure the correct API and quantity are being dispensed according to the work order.
   3. Check the ambient conditions (e.g., temperature, humidity) to ensure they are suitable for API handling.
2. Weighing/Measuring API
   1. Weigh the required quantity of the API using a calibrated balance. For APIs that are highly potent, use appropriate weighing techniques (e.g., analytical balances, and precision instruments).
   2. Double-check the weighed amount against the work order and batch record. Ensure no contamination or spillage occurs during weighing.
3. Transfer to Dispensing Container
   1. Transfer the weighed API into a clean, labeled dispensing container, ensuring that no API is lost during the transfer.
   2. Label the dispensing container with the API name, batch number, quantity, dispensing date, and the responsible personnel’s initials.
   3. If handling multiple APIs, ensure strict segregation of materials to avoid cross-contamination.

5.3 API Handling Safety Protocols

Follow these safety protocols to prevent contamination and ensure worker safety:

1. Personal Protective Equipment (PPE)
   1. All personnel involved in API dispensing must wear appropriate PPE, such as gloves, masks, lab coats, and safety glasses, as per the material’s safety guidelines.
2. Containment Measures
   1. APIs should be handled in a clean room or a designated dispensing area with adequate containment measures to prevent airborne contamination.
   2. Use proper ventilation systems (e.g., fume hoods) when dispensing APIs that may be harmful if inhaled.

5.4 Labeling of Dispensed APIs

Label dispensed APIs accurately with the following information:

1. Required Labeling Information
   1. Material name, batch number, quantity dispensed, dispensing date, and work order reference number.
   2. Label with warnings, handling instructions, and any safety precautions relevant to the API (e.g., “Store in a cool, dry place,” or “Handle with care”).
2. Label Placement
   1. Ensure that the label is affixed securely to the dispensing container and is clearly visible for easy identification.

5.5 Storage of Dispensed APIs

Follow these procedures for the proper storage of dispensed APIs:

1. Storage Conditions
   1. Store dispensed APIs in a designated storage area with appropriate conditions (e.g., controlled temperature, humidity).
   2. Ensure APIs are clearly labeled as “Dispensed” and are segregated from other materials to prevent mix-ups.
2. Inventory Management
   1. Update the inventory management system to reflect the dispensed quantities of each API.
   2. Monitor the usage of dispensed APIs to ensure that the correct quantities are being used in the manufacturing process and that no API is wasted.

5.6 Handling Rejected or Non-Conforming APIs

If APIs are found to be non-conforming or rejected during dispensing, follow these steps:

1. Quarantine the affected batch immediately and label it as “Rejected.”
2. Notify the QA and Procurement teams to resolve the issue, which may involve returning the API to the supplier or requesting a replacement.
3. Document the issue in the Discrepancy Report (Annexure-1) and follow up with corrective actions.

6. Abbreviations

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

7. Documents

1. Discrepancy Report (Annexure-1)
2. API Dispensing Log (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: Discrepancy Report

Date	Material Name	Batch Number	Issue Description	Corrective Action
02/02/2025	API-123	Batch 67890	Out of Specification	Returned to Supplier

Annexure-2: API Dispensing Log

Date	API Name	Batch Number	Quantity Dispensed	Responsible Personnel
03/02/2025	API-123	Batch 67890	200 g	Jane Smith

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