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Vendor Quality Agreement
"Need a Vendor Quality Agreement for our pharmaceutical manufacturing supplier based in Manchester, with specific focus on GMP compliance and monthly quality audits, to be effective from March 2025."
1. Parties: Identification of vendor and purchaser, including full legal names and addresses
2. Background: Context of the agreement and purpose of quality requirements
3. Definitions: Key terms used throughout the agreement
4. Quality Management System Requirements: Vendor's obligations regarding quality management systems and standards
5. Specifications and Standards: Detailed quality specifications and applicable industry standards
6. Audit Rights: Purchaser's rights to audit vendor's facilities and processes
7. Non-Conformance Management: Procedures for handling non-conforming products/services
8. Documentation and Records: Requirements for maintaining quality-related documentation
9. Term and Termination: Duration of agreement and termination provisions
1. Regulatory Compliance: Additional requirements for regulated industries such as pharmaceuticals or medical devices
2. Environmental Requirements: Environmental standards and compliance requirements when environmental impact is relevant
3. Change Control: Process for managing changes to specifications or processes in complex manufacturing arrangements
4. Subcontractor Management: Requirements and procedures for managing subcontractors when applicable
1. Schedule 1 - Quality Specifications: Detailed technical specifications and quality parameters
2. Schedule 2 - Audit Procedures: Detailed procedures for conducting quality audits
3. Schedule 3 - Non-Conformance Procedures: Detailed procedures for handling quality issues
4. Schedule 4 - Required Documentation: List of required quality documentation and records
5. Schedule 5 - Key Performance Indicators: Metrics for measuring quality performance
6. Schedule 6 - Contact Details: Key contacts for quality-related communications
Authors
Applicable Laws
Audit
Commencement Date
Confidential Information
Corrective Action
Critical Quality Attributes
Defect
Deliverables
Good Manufacturing Practice (GMP)
Initial Term
Inspection
Key Performance Indicators (KPIs)
Non-Conformance
Preventive Action
Products
Quality Management System (QMS)
Quality Manual
Quality Records
Quality Requirements
Quality Specifications
Regulatory Authority
Services
Specifications
Standard Operating Procedures (SOPs)
Subcontractor
Supplier/Vendor
Term
Testing Procedures
Validation
Specifications and Standards
Documentation Requirements
Audit Rights
Non-Conformance Management
Change Control
Regulatory Compliance
Quality Control Testing
Record Retention
Personnel Training
Subcontractor Management
Inspection Rights
Product Release Requirements
Confidentiality
Risk Management
Corrective and Preventive Actions
Validation Requirements
Complaints Handling
Communication Procedures
Environmental Requirements
Health and Safety
Governing Law
Dispute Resolution
Force Majeure
Term and Termination
Indemnification
Insurance Requirements
Intellectual Property
Notice Requirements
Amendments
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