The Contract Manufacturing Quality Agreement Template is essential for organizations engaging in outsourced manufacturing relationships under English and Welsh law. This document establishes clear quality control standards, defines responsibilities, and ensures compliance with regulatory requirements including MHRA guidelines and GMP standards. It is particularly crucial in regulated industries where product quality directly impacts public health and safety. The agreement covers quality management systems, manufacturing specifications, testing protocols, documentation requirements, and compliance obligations, serving as a cornerstone for maintaining consistent product quality across manufacturing operations.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Your data doesn't train Genie's AI
You keep IP ownership of your docs
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
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.
Download
Contract Manufacturing Quality Agreement
An English law agreement defining quality standards and responsibilities between contract manufacturers and product owners.
Download
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.
Download
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.
Download
Toll Processing Agreement
An England & Wales contract outlining outsourced material processing terms, responsibilities, and compliance standards.
Download
Private Label Contract
An England & Wales contract outlining terms for outsourcing product manufacturing under a private brand.
Download
Oem Contract Manufacturing Agreement
An England & Wales agreement outlining third-party manufacturing terms, ensuring quality and protecting intellectual property.
Download
Manufacturing Distribution Agreement
An England & Wales legal agreement outlining manufacturer-distributor rights, obligations, and compliance for market expansion.
Download
Oem Contract
A template agreement under English and Welsh law governing the manufacturing relationship between OEMs and contract manufacturers.
Download
Clothing Manufacturing Contract
An English law contract template governing the relationship between clothing manufacturers and clients, covering production specifications, quality standards, and delivery terms.
Download
Manufacturing Supplier Contract
A legal agreement under English and Welsh law governing the manufacture and supply of products between a manufacturer and customer.
Download
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
We are ISO27001 certified, so your data is secure
Organizational security:
You retain IP ownership of your documents and their information
You have full control over your data and who gets to see it
.png)
.png)