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Quality Control Agreement
"I need a Quality Control Agreement for my pharmaceutical manufacturing company to establish quality standards with our third-party testing laboratory in Manchester, starting from March 2025, with specific focus on GMP compliance and MHRA requirements."
1. Parties: Identification and details of the contracting parties
2. Background: Context and purpose of the agreement
3. Definitions: Key terms used throughout the agreement
4. Quality Control Requirements: Specific quality standards, specifications, and acceptance criteria
5. Testing Procedures: Detailed procedures for quality control testing
6. Non-Conformance Procedures: Process for handling non-conforming products
7. Documentation Requirements: Required quality control records and documentation
1. Industry-Specific Requirements: Additional requirements for specific industries (e.g., medical, food) - include when the agreement covers regulated industries
2. Laboratory Testing: Requirements for external laboratory testing - include when third-party testing is required
3. Environmental Controls: Environmental requirements for quality control - include when environmental factors affect product quality
1. Schedule 1 - Quality Control Specifications: Detailed technical specifications and acceptance criteria
2. Schedule 2 - Testing Methods: Detailed testing procedures and methodologies
3. Schedule 3 - Sample Forms: Templates for quality control documentation
4. Schedule 4 - Contact Details: List of key personnel and their responsibilities
Authors
Batch
Certificate of Analysis
Conformance
Control Sample
Corrective Action
Critical Quality Attributes
Deviation
Effective Date
Good Manufacturing Practice (GMP)
Inspection
Laboratory Testing
Non-conformance
Out of Specification (OOS)
Preventive Action
Product Specifications
Quality Control
Quality Control Methods
Quality Management System
Quality Records
Quality Standards
Raw Materials
Reference Standards
Rejection Criteria
Sample
Sampling Plan
Services
Specification
Standard Operating Procedure (SOP)
Test Method
Testing Facility
Testing Protocol
Validation
Testing Procedures
Acceptance Criteria
Non-conformance Procedures
Documentation Requirements
Inspection Rights
Sample Retention
Record Keeping
Confidentiality
Personnel Requirements
Equipment Calibration
Change Control
Dispute Resolution
Liability and Indemnification
Force Majeure
Term and Termination
Regulatory Compliance
Audit Rights
Communication Protocols
Health and Safety
Environmental Controls
Training Requirements
Subcontracting
Insurance
Warranties
Intellectual Property
Data Protection
Remedial Actions
Emergency Procedures
Reporting Requirements
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