Create a bespoke document in minutes, or upload and review your own.
Get your first 2 documents free
Your data doesn't train Genie's AI
You keep IP ownership of your information
Contract Manufacturing Quality Agreement Template
I need a Contract Manufacturing Quality Agreement Template for our pharmaceutical company based in Manchester that will manufacture generic drugs through a third-party manufacturer in Wales, with specific emphasis on MHRA compliance and batch testing protocols to begin production in March 2025.
1. Parties: Identification of contract manufacturer and client company, including full legal names and registered addresses
2. Background: Context of the agreement, manufacturing relationship, and purpose of the quality agreement
3. Definitions: Key terms, technical specifications, and industry-specific terminology used throughout the agreement
4. Quality Management System: Overview of quality control processes, responsibilities, and compliance with GMP and other relevant standards
5. Manufacturing Requirements: Specific manufacturing standards, processes, and compliance with Medicines Act 1968 and related regulations
6. Quality Control: Testing, inspection requirements, and quality assurance procedures in accordance with regulatory standards
7. Documentation Requirements: Record keeping standards, batch documentation, and retention requirements
8. Compliance Obligations: Regulatory compliance requirements including MHRA guidelines and applicable UK/EU regulations
9. Term and Termination: Duration of agreement, termination provisions, and post-termination obligations
1. Technology Transfer: Procedures and requirements for transferring manufacturing technology between parties
2. Validation Requirements: Specific validation protocols for new product lines or manufacturing processes
3. Export Requirements: Additional quality requirements and compliance standards for international market distribution
1. Schedule 1: Product Specifications: Detailed technical specifications for products including quality standards and acceptance criteria
2. Schedule 2: Quality Control Procedures: Detailed testing and inspection procedures, including sampling methods and acceptance criteria
3. Schedule 3: Batch Release Requirements: Specific criteria and procedures for batch release approval
4. Appendix A: Contact Details: List of key personnel, emergency contacts, and escalation procedures
5. Appendix B: Change Control Procedures: Detailed processes for managing changes to specifications, procedures, or manufacturing processes
6. Appendix C: Audit Requirements: Quality auditing procedures, schedules, and requirements for both internal and external audits
Authors
Applicable Laws
Batch
Batch Manufacturing Record
Batch Release
Certificate of Analysis
Change Control
cGMP
Confidential Information
Contract Manufacturer
Critical Quality Attributes
Deviation
Effective Date
Facility
Good Manufacturing Practice
MHRA
Non-Conformance
Out of Specification
Product
Product Owner
Product Specification
Quality Control
Quality Management System
Quality Manual
Quality Standards
Raw Materials
Recall
Regulatory Authority
Release Testing
Services
Specifications
Standard Operating Procedures
Technical Agreement
Territory
Third Party
Validation
Manufacturing Standards
Compliance with Laws
Quality Control Testing
Documentation and Records
Batch Release
Change Control
Deviations and Non-Conformances
Audits and Inspections
Product Complaints
Product Recalls
Raw Material Controls
Equipment Maintenance
Personnel Training
Validation
Stability Testing
Storage and Distribution
Confidentiality
Intellectual Property
Liability and Indemnification
Force Majeure
Dispute Resolution
Term and Termination
Regulatory Compliance
Subcontracting
Insurance
Annual Review
Communication Protocols
Quality Metrics
Product Specifications
Find the exact document you need
Mobile Home Lot Lease Agreement
A legally binding agreement under English and Welsh law for leasing a mobile home pitch, establishing terms between site owners and residents.
Contract Manufacturing Quality Agreement
An English law agreement defining quality standards and responsibilities between contract manufacturers and product owners.
Third Party Manufacturing Agreement
A legal agreement governing third-party manufacturing arrangements under English and Welsh law, establishing terms for production, quality, and delivery of goods.
White Label Product Agreement
An English law agreement governing the production and supply of white label products, including IP rights, quality standards, and commercial terms.
Oem Contract
A template agreement under English and Welsh law governing the manufacturing relationship between OEMs and contract manufacturers.
Clothing Manufacturing Contract
An English law contract template governing the relationship between clothing manufacturers and clients, covering production specifications, quality standards, and delivery terms.
Manufacturing Supplier Contract
A legal agreement under English and Welsh law governing the manufacture and supply of products between a manufacturer and customer.
Download our whitepaper on the future of AI in Legal
Genie’s Security Promise
Genie is the safest place to draft. Here’s how we prioritise your privacy and security.
Your documents are private:
We do not train on your data; Genie’s AI improves independently
All data stored on Genie is private to your organisation
Your documents are protected:
Your documents are protected by ultra-secure 256-bit encryption
Our bank-grade security infrastructure undergoes regular external audits
We are ISO27001 certified, so your data is secure
Organizational security
You retain IP ownership of your documents
You have full control over your data and who gets to see it
Innovation in privacy:
Genie partnered with the Computational Privacy Department at Imperial College London
Together, we ran a £1 million research project on privacy and anonymity in legal contracts
Want to know more?
Visit our Trust Centre for more details and real-time security updates.
Read our Privacy Policy.