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Quality Control Agreement
"I need a Quality Control Agreement for my pharmaceutical manufacturing company to establish testing standards with our new third-party testing laboratory in California, with operations starting March 2025 and particularly focused on FDA compliance and batch testing procedures."
1. Parties: Identification of contracting parties and their legal status
2. Background: Context and purpose of the quality control agreement
3. Definitions: Key terms and their meanings within the agreement
4. Quality Control Standards: Specific quality requirements and acceptance criteria
5. Testing Procedures: Detailed protocols for quality testing
6. Documentation Requirements: Record-keeping and reporting obligations
7. Non-Conformance Procedures: Handling of quality issues and defects
8. Term and Termination: Duration and termination conditions
1. International Compliance: Additional requirements for international trade - use when products are exported/imported
2. Subcontractor Requirements: Quality control obligations for third parties - use when subcontractors are involved
3. Industry-Specific Requirements: Special requirements for specific industries - use for regulated industries (e.g., pharmaceuticals)
1. Schedule 1 - Quality Control Specifications: Detailed technical requirements and standards
2. Schedule 2 - Testing Methods: Specific procedures for quality testing
3. Schedule 3 - Documentation Templates: Standard forms for quality control records
4. Schedule 4 - Contact Information: Key personnel and emergency contacts
5. Schedule 5 - Service Level Agreements: Performance metrics and response times
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