Drafting quality agreements for contract manufacturing requires deep knowledge of cGMP regulations, careful allocation of quality responsibilities, and precise documentation of compliance procedures. Attorneys and regulatory professionals spend 6-8 hours researching FDA requirements, coordinating with quality units, and ensuring every clause meets regulatory standards—time that could be spent on strategic compliance initiatives.
Quality Agreements are critical regulatory documents that define quality responsibilities between product owners and contract manufacturers, but drafting comprehensive agreements that satisfy FDA expectations under 21 CFR Parts 210-211 and ICH Q7 requires deep regulatory expertise. Manual drafting takes 12-20 hours and risks missing critical compliance elements like quality unit independence, change control protocols, or data integrity requirements that FDA inspectors scrutinize.
CaseMark's AI analyzes your manufacturing contracts, product specifications, and regulatory requirements to generate comprehensive Quality Agreements that meet current FDA guidance. The system incorporates best practices from the 2016 FDA Guidance on Contract Manufacturing Arrangements, ensures proper delineation of quality responsibilities, and creates enforceable provisions covering all critical areas from batch release to regulatory inspections.
This workflow is applicable across multiple practice areas and use cases
Quality agreements are critical due diligence documents in pharmaceutical M&A transactions and must be reviewed or drafted when acquiring companies with contract manufacturing relationships.
M&A attorneys handling pharmaceutical deals need to assess existing quality agreements with CMOs as part of operational due diligence and often need to draft new agreements post-acquisition to ensure regulatory compliance continuity.
Healthcare attorneys advising hospitals, compounding pharmacies, and medical device companies need quality agreements when outsourcing manufacturing of pharmaceuticals or medical products to ensure regulatory compliance.
Healthcare law overlaps significantly with FDA compliance, and attorneys in this space regularly handle contract manufacturing arrangements for healthcare entities that must meet the same cGMP and quality standards.
Pharmaceutical licensing agreements often involve contract manufacturing arrangements where quality agreements define how licensed products will be manufactured to regulatory standards.
IP licensing attorneys in pharma/biotech regularly need quality agreements when licensing deals include manufacturing rights or technology transfer, ensuring the licensee maintains cGMP compliance for licensed products.
In-house corporate counsel at pharmaceutical and biotech companies routinely negotiate and draft quality agreements as essential commercial contracts governing outsourced manufacturing relationships.
Corporate attorneys managing commercial contracts for pharma/biotech companies need quality agreements as a standard contract type, representing a significant portion of their contract portfolio when managing CMO relationships.
A Quality Agreement is a regulatory document that defines quality-related roles, responsibilities, and compliance obligations between a product owner and contract manufacturer. While not explicitly required by FDA regulations, the 2016 FDA Guidance for Industry on Contract Manufacturing Arrangements strongly recommends Quality Agreements to clearly delineate quality responsibilities and ensure cGMP compliance. FDA inspectors routinely request these agreements during inspections to verify proper quality oversight of outsourced manufacturing.
A Quality Agreement focuses exclusively on quality assurance, regulatory compliance, and cGMP requirements, while manufacturing agreements address commercial terms like pricing, volumes, and delivery schedules. The Quality Agreement establishes that quality decisions take precedence over commercial considerations and defines technical matters like specifications, change control, deviation investigations, and batch release authority. These documents complement each other but serve distinct purposes, with the Quality Agreement ensuring regulatory compliance independent of business pressures.
FDA expects Quality Agreements to clearly define each party's quality unit responsibilities, establish batch release and disposition authority, outline comprehensive change control procedures, specify audit rights and regulatory inspection protocols, and detail procedures for managing deviations and quality events. The agreement must demonstrate quality unit independence from commercial pressures, establish proper documentation and record retention requirements, and ensure both parties understand their regulatory obligations. FDA's 2016 guidance emphasizes that ambiguity in quality responsibilities is a common deficiency.
Quality Agreements should be reviewed at least every two to three years to ensure alignment with current regulatory guidance, industry best practices, and any changes in the manufacturing relationship. They must be updated whenever significant changes occur such as new product additions, facility changes, regulatory requirement updates, or lessons learned from inspections or quality events. The agreement should include provisions for amendment procedures and change control to ensure both parties approve modifications that affect quality responsibilities or compliance obligations.
The product owner's Quality Unit typically retains final batch disposition authority, even when the contract manufacturer performs release testing. This ensures the product owner maintains ultimate accountability for product quality and regulatory compliance. The Quality Agreement should clearly specify that the contract manufacturer may place batches on quality hold and perform initial testing, but final release for distribution requires the product owner's approval based on review of complete batch documentation including manufacturing records, testing results, and deviation assessments.