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Vendor Quality Agreement
"I need a Vendor Quality Agreement for my pharmaceutical manufacturing company based in Kuala Lumpur, with specific focus on GMP compliance and raw material testing requirements, to be used with multiple international suppliers starting from January 2025."
1. Parties: Identification of the parties entering into the agreement, including full legal names and registered addresses
2. Background: Context of the agreement, relationship between parties, and purpose of establishing quality standards
3. Definitions: Detailed definitions of technical terms, quality-related terminology, and key concepts used throughout the agreement
4. Scope of Agreement: Defines the products/services covered and the extent of quality requirements
5. Quality Management System Requirements: Specifies the quality management system standards that the vendor must maintain
6. Documentation and Record Keeping: Requirements for maintaining quality-related documentation and records
7. Audit and Inspection Rights: Details the customer's rights to audit the vendor's facilities and quality systems
8. Non-conformance and Corrective Actions: Procedures for handling quality issues and implementing corrective measures
9. Change Control: Process for managing changes to products, processes, or specifications
10. Communication Protocol: Procedures for regular communication and quality-related notifications
11. Term and Termination: Duration of the agreement and conditions for termination
12. Confidentiality: Protection of proprietary information exchanged during quality management activities
13. Governing Law and Jurisdiction: Specification of Malaysian law as governing law and jurisdiction for disputes
1. Regulatory Compliance: For regulated industries, specific section addressing compliance with regulatory requirements
2. Environmental Management: When environmental impact is significant, requirements for environmental management systems
3. Subcontractor Management: When subcontractors are involved, requirements for managing their quality standards
4. Product Testing and Validation: For products requiring specific testing protocols
5. Quality Metrics and KPIs: When specific performance measurements are required
6. Training Requirements: When specific staff training and certification requirements are necessary
7. Business Continuity: For critical suppliers, requirements for ensuring continuous supply
1. Schedule 1: Quality Specifications: Detailed product or service quality specifications
2. Schedule 2: Testing Procedures: Specific testing methods and acceptance criteria
3. Schedule 3: Quality Control Points: Critical control points in the manufacturing or service delivery process
4. Schedule 4: Audit Checklist: Standard checklist for quality audits
5. Schedule 5: Reporting Templates: Standard forms and templates for quality reporting
6. Appendix A: Contact Information: List of key personnel and their roles in quality management
7. Appendix B: Change Request Form: Standard form for requesting and documenting changes
8. Appendix C: Non-conformance Report Template: Standard template for reporting quality issues
Authors
Applicable Laws
Audit
Authorized Representative
Batch
Certificate of Analysis
Change Control
Confidential Information
Corrective Action
Critical Quality Attributes
Defect
Deviation
Documentation
Effective Date
Good Manufacturing Practice
Inspection
Key Performance Indicators
Major Non-conformance
Manufacturing Process
Minor Non-conformance
Out of Specification
Preventive Action
Quality Management System
Quality Manual
Quality Policy
Quality Records
Quality Requirements
Quality Specifications
Raw Materials
Regulatory Authority
Root Cause Analysis
Sample
Service Level Agreement
Specifications
Standard Operating Procedure
Subcontractor
Supplier
Technical Requirements
Testing Procedures
Validation
Vendor
Verification
Documentation Requirements
Compliance
Audit Rights
Quality Control
Testing and Inspection
Non-conformance Management
Corrective Actions
Change Control
Personnel and Training
Subcontractor Management
Record Keeping
Confidentiality
Liability
Force Majeure
Dispute Resolution
Term and Termination
Governing Law
Product Specifications
Manufacturing Controls
Equipment Maintenance
Storage and Handling
Shipping and Distribution
Performance Metrics
Communication Protocol
Environmental Requirements
Health and Safety
Insurance
Intellectual Property
Warranties
Procurement Manager
Supply Chain Director
Quality Control Supervisor
Vendor Management Specialist
Compliance Officer
Operations Director
Technical Director
Manufacturing Manager
Quality Systems Engineer
Regulatory Affairs Manager
Contract Manager
Chief Quality Officer
Production Manager
Supply Chain Manager
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