A signed quality agreement can still leave a manufacturing team unsure who must act when a batch deviates, a supplier changes, or records arrive late. For pharmaceutical product owners and contract manufacturers, the useful question is whether the agreement supports clear decisions during actual work.
This checklist offers a practical way to review those handoffs before starting a new relationship or expanding an existing one. It focuses on operational implementation rather than contract pricing or legal terms.
Start with the regulatory boundary
FDA’s November 2016 quality agreements guidance recommends documenting the parties’ manufacturing responsibilities. An agreement cannot transfer away either party’s obligations to comply with current good manufacturing practice, or CGMP. The guidance describes recommendations and cites applicable requirements; these are different types of authority.
Its stated scope is commercial drug manufacturing. For clinical work, use the applicable requirements and development stage, rather than treating every commercial arrangement as an identical template.
1. Map the work before reviewing the wording
Choose one product and trace its path from material receipt through manufacture, testing, review, storage, and shipment. At each handoff, ask who performs the task, who reviews the result, and what evidence the next team needs.
Include outside laboratories and other subcontracted activities in the map. A generic reference to “the contractor” may hide several different organizations. Record the actual site, contact role, and approved communication route for each interface.
2. Build a responsibility and evidence table
Use the following questions as a working review aid. Resolve gaps through approved quality procedures and agreement revisions.
| Activity | Question to settle | Practical evidence |
|---|---|---|
| Deviation | Who alerts whom, assesses impact, and closes the investigation? | Notification record and approved investigation |
| Change | Which reviews and approvals are needed before implementation? | Change assessment and documented decision |
| Testing | Who owns methods, sample handling, and result review? | Approved instructions and accessible results |
| Batch disposition | What must each quality unit review before its decision? | Defined review package and disposition record |
| Storage | Who responds to excursions and communicates affected inventory? | Temperature evidence and impact assessment |
FDA addresses quality unit activities, production documentation, and change control in its guidance. Product owners retain final release responsibilities; the contract facility also has responsibilities for its own operations. Match the table to the actual arrangement rather than assuming one party handles everything.
3. Make notification rules usable
Replace vague phrases such as “notify promptly” with agreed triggers, contact routes, and response expectations appropriate to risk. Identify a backup when the main contact is unavailable. Distinguish an initial alert from the completed investigation package.
Test the route with a hypothetical event: a storage alarm occurs outside normal business hours. Can the facility identify affected material, contact the right people, preserve evidence, and obtain the required decisions? This is a proposed exercise, not a reported client result.
4. Check records and change handoffs
Agree on the contents of the batch review package and how teams obtain supporting records. Check whether missing attachments, unclear corrections, or separate systems create repeated requests. Define how open items are tracked without weakening release controls.
For a proposed equipment, method, or material change, walk through the impact assessment together. Confirm that technical, quality, and regulatory reviewers can see the relevant information before implementation. Keep production deadlines separate from approval authority.
5. Review whether the process works
Start with a small review of recent handoffs. Track late notifications, incomplete record packages, overdue joint actions, and repeated disputes over ownership. Use these measures to find weak interfaces rather than reward speed alone.
Assign each improvement an owner and follow-up date. Broader workflow issues can feed into a CMO manufacturing improvement plan.
Get practical GMP and operations support
PharmExcel supports GMP gap assessments, procedures, deviation and CAPA work, and manufacturing workflow improvement. If unclear handoffs are delaying decisions, review our pharmaceutical consulting services and discuss your priorities with Rob Braddock. A focused assessment can define the gaps, responsible teams, and implementation steps.