Standard Operating Procedure for Raw Material Procurement

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the procurement of raw materials required for the manufacturing of intramuscular, subcutaneous, and intravenous injection products, ensuring compliance with regulatory standards and maintaining product quality.

2) Scope

This SOP applies to all personnel involved in the procurement of raw materials for the manufacturing processes at [Company Name]. It covers the steps from identifying raw material requirements to the receipt and initial inspection of materials.

3) Responsibilities

The responsibilities of this SOP include:
– Procurement Department: Identifying raw material requirements, selecting suppliers, and placing purchase orders.
– Quality Assurance (QA): Verifying supplier qualifications and approving raw materials upon receipt.
– Warehouse Personnel: Receiving, inspecting, and storing raw materials.

4) Procedure

4.1 Identification of Raw Material Requirements
4.1.1 The Production Department determines raw material requirements based on the production schedule.
4.1.2 A purchase requisition is generated and submitted to the Procurement Department.
4.2 Supplier Selection and Qualification
4.2.1 The Procurement Department identifies potential suppliers based on the quality, reliability, and cost of materials.
4.2.2 The QA Department conducts supplier audits to ensure compliance with regulatory standards.
4.2.3 Approved suppliers are added to the Approved Supplier List (ASL).
4.3 Purchase Order Placement
4.3.1 The Procurement Department issues purchase orders to approved suppliers based on the purchase requisition.
4.3.2 Purchase orders should include detailed specifications, quantities, delivery schedules, and terms and conditions.
4.4 Receipt of Raw Materials
4.4.1 Upon arrival, warehouse personnel receive raw materials and verify the delivery against the purchase order.
4.4.2 Any discrepancies or damages are reported to the Procurement Department immediately.
4.5 Initial Inspection
4.5.1 Raw materials are initially inspected for any visible damage, correct labeling, and documentation.
4.5.2 Samples are taken and sent to the QA Department for testing and approval.
4.5.3 Accepted materials are moved to the designated storage area, and rejected materials are quarantined.

5) Abbreviations, if any

– QA: Quality Assurance
– ASL: Approved Supplier List

6) Documents, if any

– Purchase Requisition Form
– Approved Supplier List (ASL)
– Purchase Order
– Raw Material Receipt Form
– Inspection and Testing Report

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0