Purpose:
The purpose of this Standard Operating Procedure (SOP) is to define the procedure for receipt, storage, and documentation of Raw materials at the Pharma Manufacturing facility.
Scope:
This SOP is applicable to all the Raw materials received at the Pharma Manufacturing facility.
Responsibilities:
The following personnel shall be responsible for the Raw Material Receipt Procedure:
1. Raw Material Receiving Staff: Responsible for receiving, checking, and storing the Raw materials.
2. QC Analysts: Responsible for the inspection of the Raw materials.
3. QA Analysts: Responsible for approving and releasing the Raw materials.
Procedure:
1. Raw material Receiving Staff receives the Raw materials at the designated area.
2. The Receiving Staff verifies the following documents provided by the supplier:
a. Purchase Order (PO)
b. Certificate of Analysis (CoA)
c. Transport Documentation
3. The Receiving Staff proceeds with checking the Raw materials by the following methods:
a. Visual inspection for the quality of the Raw material.
b. Quantity verification against the PO.
c. Checking the expiration and manufacturing dates.
d. Checking the labeling information.
4. If discrepancies exist in the received Raw materials, the Receiving Staff informs the purchasing department and QA department immediately.
5. The Receiving Staff proceeds with labeling and categorizing the Raw materials as per the classification.
6. The Raw materials are then moved to the Quarantine section of the warehouse, which is segmented, demarcated, and documented.
7. Raw materials that require testing before releasing to the production line are given a sampling code by the Receiving Staff.
8. The process continues with the QC Analysts taking samples of Raw materials and testing them as per the pre-defined specifications.
9. After the Raw materials successfully pass the QC tests, the QA Analysts proceed with releasing the Raw materials to the production floor.
10. The QA Analysts update the inventory system with the fresh Raw Material stock, and the Raw materials’ utilization and consumption are documented accordingly.
11. The Raw Material Receiving Staff stores the released Raw materials in the finished goods section of the warehouse and documents the same.
12. The Raw Material Receiving Staff updates the inventory system, which reflects the current stock of Raw materials.
13. In case of any deviations from the SOP, the QA department shall conduct an investigation, document the findings, and take corrective actions.
14. The Raw Material Receipt Procedure is recorded in the logbook, including the details like date, Raw material name, quantity, and identification code.
15. On completion of the Raw Material Receipt Procedure, the Receiving Staff notifies the QA department of successful completion.
Conclusion:
The above Standard Operating Procedure is to be strictly followed to ensure that the Pharma Manufacturing facility receives the Raw materials of the right quality and quantity. Documenting, categorizing, and storage in the quarantined and finished goods sections ensures the proper utilization of Raw materials, and their availability as per the demand.