| name | quality-agreement |
| title | Quality Agreement for Contract Manufacturing |
| description | Drafts Quality Agreements for pharmaceutical contract manufacturing. Assigns quality roles between product owners and CMOs under FDA cGMP (21 CFR 210/211), ICH Q7, and related guidance. Use when a user needs a quality agreement, CMO quality terms, or cGMP compliance agreement for contract manufacturing. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/quality-agreement |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | life-sciences |
| language | en |
| tags | ["agreement","drafting"] |
Quality Agreement for Contract Manufacturing
Drafts an enforceable Quality Agreement defining quality roles, responsibilities, and cGMP compliance obligations between a product owner and a contract manufacturing organization (CMO).
Prerequisites
- Manufacturing/supply agreement — commercial terms, product scope, facility details
- Regulatory identifiers — FDA Establishment IDs, DUNS, DEA registrations (if controlled), ISO certs
- Product details — dosage form, API/finished product, classification (Rx, OTC, biologic)
- Existing quality documents — prior quality agreements, SOPs, inspection history (483s, warning letters)
- Specifications — approved specs, analytical methods, stability protocols
Search user-uploaded documents for existing agreements, specs, and regulatory correspondence before drafting.
Output Structure
| Section | Key Contents |
|---|
| Parties & Scope | Legal names, regulatory IDs, product scope, exclusions, quality-over-commercial supremacy clause |
| Definitions | Regulatory terms, party-specific roles |
| Quality Unit Authority | Responsibility matrix (see below), independence provisions, escalation paths |
| Manufacturing & Documentation | Batch records, retention per 21 CFR 211.180, Part 11 compliance |
| Change Control | Categories, approval workflows, review timelines (see below) |
| Audit & Inspection | Routine/for-cause/unannounced rights, 483 response coordination |
| Quality Events & CAPA | Deviation reporting, investigation, CAPA approval, recall authority |
| Specifications & Release | Method validation (ICH Q2), OOS investigations, stability programs |
| Personnel & Training | Qualifications, training programs, key personnel change notice |
| Term & Termination | Duration, termination rights, transition obligations, survival clauses |
| Appendices | Change control forms, deviation templates, quality metrics, contacts |
Quality Unit Responsibility Matrix
