Raw Material Procurement – Standard Operating Procedure
1) Purpose
To outline the process for procuring raw materials used in pharmaceutical manufacturing to ensure quality, availability, and compliance with regulatory standards.
2) Scope
This SOP applies to the procurement of raw materials within the pharmaceutical purchase department.
3) Responsibilities
Procurement Manager: Responsible for overseeing raw material procurement.
Purchasing Team: Responsible for executing the procurement process.
4) Procedure
4.1) Material Requirement Planning:
4.1.1) Forecast raw material needs based on production schedules and inventory levels.
4.1.2) Verify material specifications and quantities required.
4.2) Supplier Selection:
4.2.1) Identify qualified suppliers capable of meeting raw material specifications.
4.2.2) Evaluate suppliers based on quality, reliability, and cost considerations.
4.3) Purchase Order Creation:
4.3.1) Issue purchase orders to selected suppliers specifying raw material requirements.
4.3.2) Include delivery schedules and quality assurance requirements in purchase orders.
4.4) Receipt and Inspection:
4.4.1) Receive raw materials against purchase orders.
4.4.2) Conduct inspection to verify conformity with specifications.
4.5) Documentation and Records:
4.5.1) Maintain records of raw material procurement activities including purchase orders, receipts, and inspection reports.
4.5.2) Ensure compliance with documentation requirements.
5) Abbreviations, if any
N/A
6) Documents, if any
- Raw Material Specifications
- Purchase Orders
- Material Inspection Reports
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.84, ICH Q7
Industry Standards: ISO 9001:2015
8) SOP Version
Version 1.0
