Quality Agreement

Draft Pharma Quality Agreements in Minutes, Not Hours

14 minutes with CaseMark

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Upload your documents and get a finished work product in minutes. New accounts get $5 free to run their first skill.

14 minutes with CaseMark

What you'll need

Manufacturing or Supply Agreement
Product Specifications

SOC 2 Type II · HIPAA compliant · $5 free credit

Workflow

Overview

CaseMark's Quality Agreement skill uses AI to draft comprehensive Quality Agreements for pharmaceutical contract manufacturing relationships. It maps quality roles and responsibilities between product owners and CMOs under FDA cGMP regulations (21 CFR 210/211), ICH Q7, and related guidance, producing a complete agreement with responsibility matrices, change control workflows, and compliance appendices.

Drafting Quality Agreements for contract manufacturing is a painstaking process that typically takes weeks of back-and-forth between quality, regulatory, and legal teams. Missing a single cGMP requirement or misassigning a quality responsibility can lead to FDA observations, warning letters, or product recalls. The complexity of aligning 21 CFR 210/211, ICH Q7, and company-specific SOPs makes manual drafting error-prone and resource-intensive.

CaseMark automates the drafting of pharmaceutical Quality Agreements by analyzing your manufacturing agreements, product specifications, and regulatory documents to produce a comprehensive, cGMP-compliant agreement. The AI maps every quality function to the appropriate party, generates change control and CAPA frameworks, and includes actionable appendices—delivering in minutes what traditionally takes weeks of cross-functional coordination.

How it works

1. Upload your manufacturing agreement, product specifications, and any existing quality documents
2. AI analyzes documents and maps quality responsibilities under FDA cGMP and ICH Q7 frameworks
3. Review and customize the drafted Quality Agreement, responsibility matrix, and appendices
4. Export the finalized agreement in your preferred format (DOCX, PDF)

What you get

Parties & Scope with Regulatory IDs
Definitions and Quality Unit Authority Matrix
Manufacturing, Documentation & Part 11 Compliance
Change Control Categories and Approval Workflows
Audit, Inspection & Quality Event Provisions
Specifications, Release & Stability Programs
Personnel, Training & Key Personnel Requirements
Term, Termination & Transition Obligations
Appendices with Templates and Contact Lists

What it handles

Generates complete Quality Agreements with FDA cGMP and ICH Q7 compliance
Builds Quality Unit Responsibility Matrix assigning roles between product owner and CMO
Drafts change control workflows with categorization and approval timelines
Includes audit and inspection rights provisions with 483 response coordination
Produces CAPA frameworks, deviation reporting protocols, and recall authority clauses
Generates appendices with change control forms, deviation templates, and quality metrics

Required documents

Manufacturing or Supply Agreement
The commercial manufacturing or supply agreement defining product scope, facility details, and contractual terms between the product owner and CMO
.pdf, .docx
Product Specifications
Approved product specifications including dosage form, API details, analytical methods, and product classification (Rx, OTC, biologic)
.pdf, .docx, .xlsx

Supporting documents

Existing Quality Agreement
Any prior quality agreement between the parties that can serve as a baseline for the new draft
.pdf, .docx
Regulatory Correspondence
FDA 483 observations, warning letters, establishment registration details, or inspection history
.pdf, .docx
Standard Operating Procedures
Relevant SOPs for change control, deviation management, CAPA, or batch release processes
.pdf, .docx
Stability Protocols
Approved stability study protocols and historical stability data for the products in scope
.pdf, .docx

Why teams use it

Reduce drafting time from weeks to minutes while maintaining full regulatory compliance coverage

Ensure no critical cGMP provisions are missed with AI-driven completeness checks against FDA and ICH frameworks

Generate standardized responsibility matrices that clearly delineate product owner and CMO quality obligations

Produce ready-to-use appendices including change control forms, deviation templates, and quality metrics dashboards

Questions

What regulatory frameworks does this Quality Agreement follow?

CaseMark drafts Quality Agreements aligned with FDA cGMP requirements under 21 CFR Parts 210 and 211, ICH Q7 guidelines, and related FDA guidance on quality agreements for contract manufacturing. The output addresses Part 11 electronic records compliance as well.

Can I customize the Quality Unit Responsibility Matrix?

Absolutely. CaseMark generates an initial responsibility matrix assigning functions to the product owner, CMO, or shared responsibility based on your uploaded documents. You can review and adjust every assignment before finalizing the agreement.

Does this handle both API and finished dosage form manufacturing?

Yes. CaseMark supports Quality Agreements for API manufacturing, finished pharmaceutical products, biologics, and OTC products. The AI adapts the agreement scope and regulatory references based on your product classification and dosage form details.

How does CaseMark handle change control provisions?

CaseMark drafts tiered change control categories with defined approval workflows, notification requirements, and review timelines. The output includes change control form templates in the appendices that both parties can adopt immediately.

Can I incorporate prior inspection history like FDA 483s?

Yes. Upload any prior 483 observations, warning letters, or inspection correspondence. CaseMark will reference relevant compliance history to strengthen audit provisions, CAPA requirements, and corrective action timelines in the drafted agreement.

Is the generated agreement ready to execute as-is?

CaseMark produces a comprehensive, professionally structured draft that covers all major regulatory requirements. However, we recommend legal and quality review by both parties before execution to ensure alignment with your specific operational and regulatory circumstances.