Purchase Order Amendments and Cancellations – Standard Operating Procedure
1) Purpose
To establish guidelines for requesting, processing, and documenting amendments and cancellations to purchase orders within the pharmaceutical purchase department.
2) Scope
This SOP applies to all purchase orders issued for materials, components, equipment, and services related to pharmaceutical manufacturing and distribution.
3) Responsibilities
Purchasing Department: Responsible for initiating and managing purchase order amendments and cancellations.
Finance Department: Responsible for processing financial adjustments related to purchase order changes.
4) Procedure
4.1) Amendment Request:
4.1.1) Identify the need for a purchase order amendment due to changes in quantities, specifications, or delivery schedules.
4.1.2) Submit a formal amendment request with justification and supporting documentation.
4.2) Approval Process:
4.2.1) Obtain necessary approvals for purchase order amendments from authorized personnel or departments.
4.2.2) Review and verify amendment requests against original purchase order terms and conditions.
4.3) Amendment Documentation:
4.3.1) Update purchase order details in the procurement system or documentation to reflect approved amendments.
4.3.2) Ensure accuracy and completeness of amended purchase order documentation.
4.4) Communication:
4.4.1) Notify suppliers of approved purchase order amendments and confirm acceptance of revised terms.
4.4.2) Maintain open communication with suppliers to resolve any discrepancies or concerns related to amendments.
4.5) Cancellation Request:
4.5.1) Assess the need for purchase order cancellation due to changes in project requirements, supplier non-performance, or other valid reasons.
4.5.2) Submit a formal cancellation request with justification and approval.
4.6) Cancellation Approval:
4.6.1) Obtain necessary approvals for purchase order cancellations in accordance with company policies.
4.6.2) Verify cancellation terms, including any applicable fees or penalties, with suppliers.
4.7) Cancellation Documentation:
4.7.1) Document purchase order cancellation details, including reasons and approvals.
4.7.2) Update procurement records to reflect cancelled purchase orders and financial adjustments.
5) Abbreviations, if any
N/A
6) Documents, if any
- Purchase Order Amendment Request Form
- Approval Records for Amendments
- Purchase Order Cancellation Request Form
- Cancellation Approval Records
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.22, ICH Q10
Industry Standards: ISO 13485:2016
8) SOP Version
Version 1.0