Quality partnership is an operating system between organizations. It should make every critical activity traceable to an owner, an approval right, a record, a timeline and an escalation route.
Responsibility matrix for a quality agreement
The final allocation depends on the product, market and legal roles. The following matrix identifies the minimum questions that should be resolved before quality-critical execution begins.
| Domain | Authorization holder / product owner | Contract manufacturer | Shared control |
|---|---|---|---|
| Governance | Maintain statutory oversight and approve defined product decisions. | Operate the site quality system and name accountable contacts. | Agree escalation, meeting rhythm, emergency availability and controlled language. |
| Technical transfer | Provide accurate product knowledge, approved process and known risks. | Assess transfer and co-line feasibility; qualify the receiving process and methods. | Approve the plan, acceptance criteria, report and unresolved-risk route. |
| Materials & suppliers | Define market and product requirements and approval rights. | Qualify, control and release materials within the agreed scope. | Define approved sources, change notification and traceability. |
| Validation | Approve product-specific strategy where required. | Execute facility, utility, equipment, cleaning, process and method work. | Agree protocols, acceptance criteria, deviation treatment and evidence access. |
| Deviation / OOS / OOT | Assess product and market impact and decide required regulatory action. | Record, investigate and control site events promptly. | Set notification clocks, investigation leadership, CAPA approval and effectiveness checks. |
| Change control | Assess filing, approval and supply impact; approve changes where required. | Initiate documented assessment and execute approved site actions. | Agree category, evidence, implementation date and inventory transition. |
| Batch disposition | Perform the final legal review or market release required by the applicable role. | Complete manufacture, testing, site review and qualified-person release activities as applicable. | Define the record package, review sequence, rejection route and decision authority. |
| Stability & retention | Maintain lifecycle commitments and trend product performance. | Execute agreed storage, testing, samples and investigations. | Define protocols, alerts, data exchange and shelf-life decision routes. |
| Complaints / recall / safety | Lead market and authority obligations as applicable. | Investigate manufacturing evidence and support urgent containment. | Set 24/7 contacts, timelines, mock recall and decision documentation. |
| Audits & inspections | Exercise oversight and communicate authority interactions. | Provide truthful access, responses and remediation evidence. | Agree audit scope, response times and inspection-notification responsibilities. |
| Records & data | Define access, review and retention needs. | Maintain original manufacturing and testing data with integrity and traceability. | Agree authoritative records, metadata, audit trails, copies, backups and transfer format. |
| Continuity & termination | Define market continuity, alternate supply and transfer needs. | Protect records and provide agreed exit assistance. | Resolve inventory, open investigations, knowledge transfer and post-termination access. |
Events that require a defined communication route
- deviations and significant quality risks
- changes and regulatory-impact assessments
- OOS, OOT and atypical results
- qualification and validation outcomes
- retention samples and stability signals
- complaints, recalls and pharmacovigilance interfaces
- regulatory inspections, observations and enforcement signals
- supply interruption, data-integrity concerns and business continuity events
Evidence should be disclosed in controlled stages
| Public | Legal entity, dated public capabilities, official regulatory sources, high-level quality approach and business contact. |
|---|---|
| After mutual NDA | Project-specific licenses or scope evidence, audit summaries, technical package excerpts, quality-system indexes and confidential questionnaires. |
| Due diligence / audit | Controlled original records, validation evidence, selected investigations, data-system demonstrations and site observations within an agreed agenda. |
| Contract ready | Executed responsibility matrix, quality agreement, technical-transfer plan, change route, supply assumptions, acceptance criteria and governance calendar. |
Additional discipline for sterile contract manufacture
For China-facing high-risk sterile contract manufacture, NMPA Announcement No. 134 (2025) requires intensified oversight, including MAH personnel supervising validation activities by on-site inspection at least annually. The same announcement also addresses experience, transfer feasibility, co-line risk, communication, change, release, audits and data. Every project must be checked against its exact regulatory pathway rather than relying on a generic facility claim.
Authoritative sources
This page supports general institution-to-institution business discussion. It is not legal, regulatory or medical advice.