storage:

1. Material Dispensing
   1. Ensure that materials to be dispensed are first verified by the Manufacturing Supervisor for the correct batch and quantity according to the work order.
   2. Ensure that dispensing is performed in a clean and controlled environment to prevent contamination or mix-up of materials.
   3. Once dispensed, verify the material using the batch record and weigh or measure according to the required quantities.
2. Labeling Materials
   1. Each dispensed material must be labeled with the following information: material name, batch number, quantity dispensed, date of dispensing, and the responsible personnel’s initials.
   2. Labels should be clear, legible, and attached securely to the material containers to ensure visibility and prevent loss of information.
   3. If any discrepancies occur during dispensing or labeling, notify the QA team immediately for further review and action.

5.2 Storage of Dispensed Materials

Follow these instructions to ensure proper storage of dispensed materials:

1. Storage Location
   1. Materials should be stored in designated areas that are clearly labeled according to the material type (e.g., excipients, APIs, packaging materials).
   2. Ensure that storage areas are clean, dry, and free from contamination or cross-contamination between different material types.
   3. Materials requiring specific conditions (e.g., temperature-sensitive) must be stored in designated storage units (e.g., refrigerators or freezers) as per the material’s requirements.
2. Inventory Management
   1. Materials should be stored in a way that allows easy access and minimizes the risk of damage or loss.
   2. Ensure that materials are stored according to FIFO (First In, First Out) to prevent the use of expired or obsolete materials.
   3. Regularly check the inventory levels of stored materials to ensure there is no excess or shortage.
3. Segregation of Rejected Materials
   1. Rejected materials must be segregated from approved materials and clearly marked as “Rejected” to prevent their accidental use.
   2. All rejected materials must be quarantined until further investigation and resolution are made.

5.3 Periodic Review and Inspection

Ensure periodic inspections and audits are performed as follows:

1. Routine Inspections
   1. Conduct routine inspections of stored materials to ensure that labels are intact and legible, and materials are properly stored.
   2. Any discrepancies should be recorded and addressed according to the Corrective and Preventive Action (CAPA) process.
2. Periodic Audits
   1. QA will perform regular audits to ensure compliance with storage and labeling procedures.
   2. Audits should include random checks of stored materials and verification of labeling accuracy and completeness.

5.4 Handling Non-Conforming or Damaged Materials

If materials are found to be non-conforming or damaged during inspection or storage, follow these steps:

1. Quarantine the affected materials immediately and label them as “Rejected.”
2. Record the incident in the Discrepancy Report (Annexure-1) and notify QA for further investigation.
3. Coordinate with Procurement to resolve the issue (e.g., return, replacement, or disposal).

5.5 Documentation and Record-Keeping

Ensure proper documentation for all labeling and storage activities:

1. Complete the Material Dispensing Log (Annexure-2) with the material details, quantity dispensed, and the name of the responsible personnel.
2. Update the inventory management system to reflect the quantity of dispensed and stored materials accurately.
3. Maintain records of all rejected materials, including the reason for rejection and corrective actions taken, in the Discrepancy Report (Annexure-1).

6. Abbreviations

• SOP: Standard Operating Procedure
• FIFO: First In, First Out
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis
• PO: Purchase Order

7. Documents

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

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	Excipient Material A	Batch 12345	Damaged Packaging	Returned to Supplier

Annexure-2: Material Dispensing Log

Date	Material Name	Batch Number	Quantity Dispensed	Responsible Personnel
03/02/2025	API-123	Batch 67890	500 g	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	Document Format and Updates	Standardization	QA Head