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Vendor Quality Agreement
"I need a Vendor Quality Agreement for my pharmaceutical manufacturing company based in Cape Town, with specific focus on GMP compliance and raw material testing requirements, to be used with multiple international suppliers starting from March 2025."
1. Parties: Identification of the parties entering into the agreement, including full legal names, registration numbers, and addresses
2. Background: Context of the agreement, including the nature of the business relationship and purpose of the quality agreement
3. Definitions: Detailed definitions of technical terms, quality-related terminology, and other important concepts used throughout the agreement
4. Scope and Term: Defines the products/services covered by the agreement and duration of the quality agreement
5. Quality Management System Requirements: Specifies the quality management system standards that the vendor must maintain
6. Responsibilities and Authorities: Detailed outline of both parties' quality-related responsibilities and decision-making authorities
7. Documentation and Record Keeping: Requirements for maintaining quality-related documentation and records
8. Change Control: Procedures for managing and communicating changes to processes, specifications, or requirements
9. Non-conformance and Corrective Actions: Procedures for handling quality issues and implementing corrective measures
10. Audits and Inspections: Rights and procedures for quality audits and inspections
11. Compliance with Regulations: Vendor's obligations to comply with relevant laws and regulations
12. Confidentiality: Protection of proprietary information exchanged during quality management activities
13. Dispute Resolution: Procedures for resolving quality-related disputes
14. Termination: Conditions and procedures for terminating the quality agreement
1. Validation and Qualification: Used when products/services require specific validation protocols or qualification procedures
2. Environmental Controls: Include when environmental conditions are critical to product quality
3. Supplier Management: Required when vendor uses sub-suppliers that impact product quality
4. Laboratory Controls: Include for agreements involving laboratory testing or analytical services
5. Product Release Requirements: Necessary when specific release procedures or certifications are required
6. Stability Program: Include for products requiring ongoing stability testing
7. Training Requirements: Add when specific training or certification of personnel is crucial
8. Business Continuity: Include when uninterrupted supply is critical to operations
1. Schedule A - Product Specifications: Detailed technical specifications for products or services covered by the agreement
2. Schedule B - Quality Control Parameters: Specific quality control requirements, testing methods, and acceptance criteria
3. Schedule C - Key Performance Indicators: Metrics and targets for measuring quality performance
4. Schedule D - Contact Details: List of key personnel and their roles in quality management
5. Schedule E - Required Documentation: List of all quality-related documents and records to be maintained
6. Appendix 1 - Audit Checklist: Standard checklist for quality audits
7. Appendix 2 - Non-conformance Report Template: Standard format for reporting quality issues
8. Appendix 3 - Change Control Form: Template for requesting and documenting changes
Authors
Applicable Laws
Audit
Batch
Certificate of Analysis
Change Control
Corrective Action
Critical Quality Attributes
Deviation
Effective Date
Good Manufacturing Practice
Inspection
Key Performance Indicators
Non-conformance
Out of Specification
Preventive Action
Quality Control
Quality Management System
Quality Manual
Quality Records
Quality Requirements
Quality Standards
Raw Materials
Recall
Regulatory Authority
SABS Standards
Specifications
Standard Operating Procedure
Supplier
Technical Agreement
Territory
Testing Methods
Validation
Vendor
Work Product
Term and Termination
Quality Management System
Regulatory Compliance
Documentation Requirements
Change Control
Non-conformance Management
Corrective and Preventive Actions
Audit Rights
Product Specifications
Testing and Inspection
Record Retention
Personnel and Training
Subcontracting
Confidentiality
Intellectual Property
Indemnification
Insurance
Force Majeure
Dispute Resolution
Governing Law
Assignment
Notices
Amendments
Entire Agreement
Severability
Manufacturing
Pharmaceuticals
Food and Beverage
Automotive
Aerospace
Medical Devices
Electronics
Chemical Industry
Consumer Goods
Healthcare
Biotechnology
Industrial Equipment
Quality Assurance
Procurement
Supply Chain
Operations
Legal
Compliance
Technical Operations
Manufacturing
Regulatory Affairs
Production
Vendor Management
Quality Control
Quality Assurance Manager
Procurement Manager
Supply Chain Director
Quality Control Specialist
Compliance Officer
Operations Manager
Technical Director
Supplier Quality Engineer
Quality Systems Manager
Regulatory Affairs Manager
Production Manager
Contract Manager
Vendor Management Specialist
Chief Quality Officer
Quality Auditor
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