This is a ready-to-use design review record for a risk- and science-based commissioning and qualification program. Design review is where quality is built in, catching the missing alarm, the uncalibratable sensor, the dead leg, before steel is cut and long before verification. This record documents a formal, SME-led review of a design against its requirements and critical aspects, and produces the suitability conclusion that supports design qualification (DQ). Replace every <<FILL: ...>> placeholder with your own specifics. Confirm each cited standard and regulation against the current source before you rely on it. This content is general educational reference, not legal or regulatory advice.
Document control header
| Field | Entry |
|---|---|
| Record title | Design Review Record |
| Record number | <<FILL: e.g. CQ-DR-021>> |
| System / equipment | <<FILL: system name and asset ID>> |
| Design stage reviewed | <<FILL: concept / basic / detailed / vendor design>> |
| Documents under review | <<FILL: URS no, FS no, DS no, P&ID rev, spec rev, drawing list>> |
| Project / C&Q plan reference | <<FILL: C&Q plan or VMP number>> |
| Review date | <<FILL: date>> |
| Chair (lead SME) | <<FILL: name, role>> |
1. Purpose and scope
This review confirms that the proposed design for <<FILL: SYSTEM>> is suitable to meet the user requirements and, in particular, that every critical aspect (a function that affects a CQA, a CPP, or patient safety) is designed so it can be built, operated, maintained, and verified. It covers the design documents listed in the header. It does not replace verification testing; it reduces the chance that verification finds a design problem that should have been caught on paper.
2. Attendees and roles
| Name | Role | Discipline represented |
|---|---|---|
<<FILL>> | Chair / lead SME | <<FILL: process / automation / mechanical>> |
<<FILL>> | SME | <<FILL>> |
<<FILL>> | Quality Assurance | Quality oversight of critical aspects |
<<FILL>> | System / process owner | Requirements owner |
<<FILL>> | Automation / CSV | Control system, alarms, audit trail, access |
<<FILL>> | Engineering / vendor | Design author |
A design review with no SME in the relevant discipline, or no Quality presence for critical aspects, is not a design review for C&Q purposes.
3. Requirements-to-design traceability checked
For each critical requirement, confirm the design addresses it and that it will be verifiable. Rows should trace back to the URS and forward to the planned verification.
| Req ID (URS) | Requirement (critical aspect) | Design element that meets it | Verifiable as designed? | Comment |
|---|---|---|---|---|
<<FILL: URS-012>> | <<FILL: temperature control +/-0.5 C (CPP)>> | <<FILL: RTD class + control loop + jacket>> | Yes / No | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | Yes / No | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | Yes / No | <<FILL>> |
A “No” in the verifiable column is a finding: a requirement you cannot verify as designed is a design defect, not just a testing problem. A common example is an acceptance criterion of +/-0.5 C against an installed sensor whose calibrated accuracy is +/-0.6 C; the design cannot pass honestly, and the review is the last cheap place to catch it.
4. Design review checklist (adapt to the system)
| # | Review item | Result (Pass / Finding / N/A) | Reference |
|---|---|---|---|
| 1 | Every critical aspect has a design element that controls or monitors it | ||
| 2 | Instruments for critical measurements are of adequate accuracy and are calibratable in place | ||
| 3 | Alarms and interlocks for safety- and quality-critical conditions are specified and testable | ||
| 4 | No dead legs, unsanitary drainage, or cleanability problems in product-contact paths | ||
| 5 | Materials of construction suit the product, process, and cleaning agents | ||
| 6 | The computerized system layer (access control, audit trail, data flow, time source) is specified per GAMP 5 and Part 11 / Annex 11 | ||
| 7 | Maintenance and calibration access is designed in, not bolted on | ||
| 8 | The design is consistent across P&IDs, specifications, and drawings (no contradictions) | ||
| 9 | Applicable codes, GEP, and standards are met | ||
| 10 | The design is verifiable end to end against the planned C&Q strategy |
5. Findings and disposition
| Finding # | Description | Criticality | Action / design change | Owner | Due | Status |
|---|---|---|---|---|---|---|
<<FILL: DR-01>> | <<FILL>> | <<FILL: Critical / Non-critical>> | <<FILL>> | <<FILL>> | <<FILL>> | Open / Closed |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
6. Acceptance criteria and conclusion
The design is suitable when: every critical requirement traces to a design element that meets it and is verifiable; every critical finding has an agreed action; and the checklist has no unresolved critical item. Non-critical findings may be tracked to closure without holding the design.
Conclusion (design suitability): <<FILL: Suitable / Suitable with actions / Not suitable, re-review required>>
This conclusion supports the design qualification for the system. Design qualification is the documented verification that the proposed design is suitable for the intended purpose; this record is the evidence behind that DQ statement.
7. References
ASTM E2500, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment (current revision), on design review and verification of critical aspects. EU GMP Annex 15, Qualification and Validation, on design qualification. ISPE Baseline Guide, Commissioning and Qualification (second edition), for the design-review practice. ICH Q9(R1) Quality Risk Management; ICH Q8 / Q11 for the CQA/CPP and control-strategy basis. GAMP 5 (second edition) for the computerized-system design elements.
Confirm the current version and clause numbers of each reference before issue.
8. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Chair / lead SME | <<FILL>> | ||
| Quality Assurance | <<FILL>> | ||
| System / process owner | <<FILL>> |
9. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
The following shows the record completed for an example jacketed production bioreactor at the detailed-design stage. Numbers are illustrative.
System: Bioreactor BR-2000-A, detailed design. Documents: URS-BR-001 rev 3, FS-BR-002 rev 2, P&ID rev C. Chair: lead process SME.
Traceability sample:
| Req ID | Requirement (critical aspect) | Design element | Verifiable as designed? | Comment |
|---|---|---|---|---|
| URS-014 | Temperature control 37.0 +/-0.5 C (CPP) | RTD (calibrated accuracy +/-0.15 C) + cascade loop + jacket | Yes | Sensor accuracy comfortably inside the band |
| URS-021 | pH control 7.0 +/-0.2 (CPP) | Two-electrode array + auto buffer addition | Yes | Spare electrode for in-run failure |
| URS-030 | Sterile boundary integrity (CQA: sterility) | Pressure-hold design + integrity-testable filters | Yes | Test connections designed in |
| URS-045 | Batch record audit trail (Annex 11) | DCS historian, per-entry timestamp, access roles | Yes | Confirmed against CSV design |
Findings: DR-01 (critical): the originally specified jacket temperature transmitter had a calibrated accuracy of +/-0.6 C against a +/-0.5 C requirement; action was to upgrade the transmitter class before build. DR-02 (non-critical): a sample valve was awkward to reach for maintenance; action tracked, did not hold the design. Conclusion: Suitable with actions; DR-01 closed by design change before procurement, verified at IQ.
The value is visible in DR-01: a +/-0.6 C sensor against a +/-0.5 C acceptance criterion would have been an honest impossible-to-pass verification months later and a costly retrofit. The design review caught it on paper.
Common inspection findings this record prevents
- A verification that cannot pass because the installed measurement is not accurate enough for the acceptance criterion, discovered late instead of at design.
- Critical aspects with no design element that actually controls or monitors them.
- A control-system layer (audit trail, access, time source) treated as an afterthought rather than a designed critical aspect.
- Contradictions between P&IDs, specifications, and drawings that surface during execution.
- Design reviews held with no SME in the relevant discipline and no Quality presence for critical aspects, so the review is a signature exercise.
How to adapt this record
- Set the design stage and list the exact documents and revisions under review; a review of “the design” without revisions is not traceable.
- Populate the traceability table from the URS and criticality assessment, not from the drawing set alone.
- Tailor the checklist to the system: a fluid system needs weld and dead-leg items, an automated system needs the full computerized-system row.
- Hold critical findings to closure before the design is released for procurement or build; track non-critical findings without holding the design.
- Reference this record from the design qualification statement so the DQ has evidence behind it.