Question 11 of 20 Intermediate Practical
What should a quality agreement with a contract manufacturer cover?
Short answer
It should state clearly which party does each GMP activity, from material testing and release to deviations, changes, audits, records and complaints, and how they communicate. It cannot transfer either party's legal GMP responsibility, and it should be separate from commercial terms.
Why
FDA guidance on quality agreements says each party is responsible for GMP for the activities it performs, and that the owner's quality unit remains legally responsible for approving or rejecting product made by the contractor. A quality agreement makes the division of work explicit. Typical sections are purpose and scope, definitions, resolution of disagreements, manufacturing activities and the agreement's own lifecycle.
Within manufacturing activities, the guidance calls quality unit activities and change control the most critical pieces. The agreement should say who releases what, how deviations are reported and investigated, who approves changes before they are made, how audits and inspection findings are shared, where records are kept, and who handles complaints and stability. The guidance recommends keeping it separate from, or at least severable from, commercial contracts, because pricing and liability do not belong in it and inspectors may read it.
A common failure is a template that says both parties are responsible for everything, which in practice means nobody owns the investigation. Another is a missing notification clause, so the sponsor learns of a CDMO's change to a raw material supplier only after an impurity appears. EU GMP Chapter 7 and ICH Q10 carry the same idea of a written agreement for outsourced activities.
How to work it through
- Map every GMP activity across the product's lifecycle at the contractor.
- Assign each one to the owner, the contractor or both, with a named approver.
- Define notification timelines for deviations, OOS results, changes and regulatory inspections.
- State audit rights, record retention and access to raw data.
- Define how disagreements on quality are escalated and resolved.
- Review the agreement on a set schedule and whenever scope changes.
An example
A biotech outsources drug product fill to a CDMO. The draft agreement says "Both parties shall comply with GMP." The reviewer replaces it with a matrix of 60 activities. Raw material testing goes to the CDMO, final release goes to the sponsor, and any change to a product-contact material needs sponsor approval before implementation.
Deviations must be reported within one business day and critical ones the same day. Six months later the CDMO proposes a new stopper supplier, and the matrix routes it to sponsor change control instead of a surprise in the next batch record.
Where the answer stops holding
An agreement only works if both sides follow and audit against it, so a perfect document can coexist with poor practice. It cannot make up for a contractor without the capability to meet GMP. It must be updated as products, sites and regulations change, or it quietly drifts out of date.
A strong answer covers
- Clear assignment of each GMP activity
- Release responsibilities and change control as core
- Deviation and change notification timelines
- Cannot delegate legal GMP responsibility
- Separate from commercial terms
Common mistakes
- Writing that both parties are responsible for every activity.
- Believing the contract transfers the sponsor's release responsibility to the CDMO.
- Putting pricing and liability clauses inside the quality agreement.
The interviewer might ask next
How would you audit whether a contractor is actually following the quality agreement?