Emergency Purchase Procedure – Standard Operating Procedure
1) Purpose
To establish guidelines for handling emergency procurement situations to ensure timely acquisition of critical materials or services within the pharmaceutical purchase department.
2) Scope
This SOP applies to emergency procurement situations that require immediate action to mitigate operational disruptions or safety risks.
3) Responsibilities
Procurement Manager: Responsible for overseeing emergency procurement.
Emergency Response Team: Responsible for identifying and prioritizing emergency procurement needs.
4) Procedure
4.1) Emergency Identification:
4.1.1) Identify situations requiring emergency procurement (e.g., equipment breakdown, supply chain disruption).
4.1.2) Assess urgency and impact on operations or compliance.
4.2) Supplier Identification:
4.2.1) Identify suppliers capable of providing needed materials or services on an expedited basis.
4.2.2) Verify supplier availability and capability to meet emergency requirements.
4.3) Expedited Procurement Process:
4.3.1) Expedite purchase requisition approval and supplier selection process.
4.3.2) Issue emergency purchase orders with expedited delivery instructions.
4.4) Receipt and Verification:
4.4.1) Receive emergency supplies or services.
4.4.2) Verify receipt and conformity with emergency procurement requirements.
4.5) Documentation and Reporting:
4.5.1) Document emergency procurement activities including justification, approvals, and communications.
4.5.2) Report on emergency procurement actions taken and outcomes to relevant stakeholders.
5) Abbreviations, if any
N/A
6) Documents, if any
- Emergency Purchase Justification
- Emergency Purchase Orders
- Receipt Confirmation
- Emergency Procurement Reports
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.67, ICH Q10
Industry Standards: ISO 9001:2015
8) SOP Version
Version 1.0