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SOP for Purchase Order Amendments and Cancellations

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SOP for Purchase Order Amendments and Cancellations

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.

See also  SOP for Vendor Communication Protocols

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.

See also  SOP for Supplier Corrective Action

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

See also  SOP for Procurement KPIs and Metrics
Purchase Departments Tags:Contract negotiation SOP, Emergency purchase procedure SOP, Goods receiving process SOP, Handling expired materials SOP, Inventory management SOP, Laboratory supplies procurement SOP, Manufacturing equipment procurement SOP, Material inspection SOP, Material specification SOP, Minimum stock level SOP, Order confirmation SOP, Packaging material procurement SOP, Pharmaceutical purchase SOP, Purchase return process SOP, Raw material procurement SOP, SOP for purchase order creation, SOP for purchase requisition, SOP for supplier qualification, SOP for vendor audit, Stock replenishment planning SOP, Supplier corrective action SOP, Supplier non-conformance SOP, Supplier performance monitoring SOP, Vendor communication protocol SOP, Vendor selection criteria SOP

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
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  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
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  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
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