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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
Authors
Acceptance Criteria
Batch
Certificate of Analysis
Commencement Date
Confidential Information
Control Sample
Corrective Action
Defect
Effective Date
Good Manufacturing Practice (GMP)
Inspection
Laboratory Testing
Manufacturing Process
Non-Conformance
Quality Control Procedures
Quality Management System
Quality Standards
Raw Materials
Recall
Rejection
Sample
Sampling Plan
Specifications
Standard Operating Procedures (SOPs)
Supplier
Test Methods
Testing Facility
Testing Requirements
Validation
Testing Requirements and Procedures
Inspection Rights
Documentation and Record Keeping
Non-Conformance and Corrective Actions
Confidentiality
Liability and Indemnification
Warranties
Dispute Resolution
Force Majeure
Term and Termination
Compliance with Laws and Regulations
Change Control
Subcontracting
Audit Rights
Personnel Requirements
Training Requirements
Equipment Calibration and Maintenance
Sample Retention
Product Release Procedures
Recall Procedures
Laboratory Controls
Storage and Handling Requirements
Communication Protocols
Insurance Requirements
Assignment
Notices
Governing Law
Entire Agreement
Severability
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