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SOP for Contract Negotiation and Management

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SOP for Contract Negotiation and Management

Contract Negotiation and Management – Standard Operating Procedure

1) Purpose

To establish guidelines for negotiating contracts with suppliers and managing contract terms to ensure compliance and optimal business outcomes.

2) Scope

This SOP applies to contract negotiation and management activities within the pharmaceutical purchase department.

3) Responsibilities

Procurement Manager: Responsible for leading contract negotiations.
Legal Department: Responsible for reviewing and approving contracts.

4) Procedure

4.1) Needs Assessment:
4.1.1) Identify requirements and objectives for the procurement contract.
4.1.2) Determine key performance indicators (KPIs) and deliverables.

4.2) Supplier Selection:
4.2.1) Assess potential suppliers based on capability and suitability.
4.2.2) Shortlist suppliers for contract negotiations.

See also  SOP for Vendor Selection Criteria

4.3) Negotiation Planning:
4.3.1) Plan negotiation strategy including objectives and fallback positions.
4.3.2) Prepare negotiation team and documentation.

4.4) Contract Negotiation:
4.4.1) Conduct negotiations with selected supplier(s) to reach agreement on terms and conditions.
4.4.2) Document agreed-upon terms and obtain signatures.

4.5) Contract Management:
4.5.1) Communicate contract terms to relevant departments.
4.5.2) Monitor supplier performance and compliance throughout contract duration.

5) Abbreviations, if any

N/A

6) Documents, if any

  • Contract Negotiation Plan
  • Contract Templates
  • Contract Approval Forms

7) Reference, if any

Regulatory Guidelines:

FDA CFR Part 211.84, ICH Q9
Industry Standards: ISO 9001:2015

8) SOP Version

Version 1.0

See also  SOP for Raw Material Procurement
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
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  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
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NEW! Revised SOPs – V 2.0

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