casemark/quality-agreement
skills/legal/quality-agreement/SKILL.md
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.
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SKILL.md
- name:
- quality-agreement
- 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.
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
| Function | Product Owner | CMO | |----------|:---:|:---:| | Final batch disposition | ● | | | In-process controls execution | | ● | | Specification approval | ● | | | Deviation investigation | | ● | | Deviation report approval | ● | | | Regulatory submissions | ● | | | Environmental monitoring | | ● | | Equipment qualification | | ● | | Change control approval (major) | ● | | | Complaint handling (mfg-related) | | ● | | Recall decision authority | ● | |
Notification Timelines
| Event | Deadline | |-------|----------| | Critical quality event (safety/regulatory) | 24 hours | | Significant quality event | 72 hours | | Routine quality event | 5 business days | | Unannounced regulatory inspection | 4 hours | | Announced regulatory inspection | 24 hours | | Key personnel change | 30 days advance |
Change Control Framework
| Category | Examples | Approval | Review Period | |----------|----------|----------|---------------| | Minor | Admin SOP updates, like-for-like equipment | CMO QU (notify owner) | 15 business days | | Major | Critical process params, alt. suppliers, method revisions | Product owner QU written approval | 30 business days | | Emergency | Immediate safety/compliance | CMO implements → retrospective owner approval | Immediate |
Change proposals must include: description, scientific justification, risk assessment (FMEA/ICH Q9), validation protocols if applicable, regulatory impact analysis, implementation timeline.
Audit Rights
- Pre-approval — before manufacturing initiation
- Routine — ≤24-month intervals, 30 days advance notice
- For-cause — triggered by quality events or regulatory concerns
- Unannounced — preserved right for serious quality/regulatory concerns
- Scope — unrestricted access to batch records, validation reports, deviations, training records, personnel interviews, facility inspection
- Post-audit — report within 30 days; CMO CAPA response within 15 business days
Batch Records & Documentation
- Contemporaneous recording (indelible ink or validated electronic systems)
- Complete material genealogy and traceability
- CMO initial review: 5–10 business days post-batch completion
- Product owner QU review: 10–15 additional business days before disposition
- Retention: ≥1 year past expiry or 3 years post-distribution (whichever longer) per 21 CFR 211.180
- Part 11 compliance: system validation, audit trails, data integrity controls
Termination & Transition
- Non-renewal notice: ≥180 days before term expiry
- Material breach cure: 60 days from written notice
- Convenience termination: 180–360 days advance notice
- Post-termination: CMO supports product through shelf life (stability, reserve samples, complaints, inspections)
- Document transfer: Complete batch records and quality documentation within 90 days
- Survival: Confidentiality (indefinite), record retention (regulatory periods), regulatory support (while product in distribution)
Guidelines
- Use mandatory language ("shall," "must") — never aspirational ("should," "will")
- Include explicit quality-over-commercial supremacy clause; quality decisions independent from commercial considerations
- Align with FDA 2016 Guidance: Contract Manufacturing Arrangements for Drugs: Quality Agreements [VERIFY]
- Address data integrity per FDA 2018 Data Integrity and Compliance with Drug CGMP guidance [VERIFY]
- For international markets, incorporate ICH Q7, EU GMP Annex 11, WHO guidelines as applicable
- Include cybersecurity provisions for manufacturing systems and confidential regulatory data
- Quality agreement governs all quality matters; ensure no conflict with underlying supply agreement
- If user provides 483s or warning letters, incorporate preventive measures addressing cited deficiencies
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