This is a ready-to-use onboarding checklist for anyone starting a GMP-regulated role, whether in production, QC, QA, or a support function that touches regulated records. It walks day one through the first 90 days, built around four things every new GMP employee needs fast: how to find and use the document control system, how their training record actually works, how to raise a deviation, and who in Quality dispositions the product or process they will touch. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
Checklist control
| Field | Entry |
|---|---|
| Employee name | <<FILL>> |
| Role / department | <<FILL>> |
| Start date | <<FILL>> |
| Manager | <<FILL>> |
| Training / QA point of contact | <<FILL>> |
| Checklist owner | <<FILL: role, e.g. Manager or Training Coordinator>> |
1. Day one
| # | Item | Owner confirms | Complete (Y/N, date) | Notes |
|---|---|---|---|---|
| 1.1 | System access and badge access provisioned, scoped to the role, no shared credentials issued | IT / Manager | <<FILL>> | <<FILL>> |
| 1.2 | Site quality policy and quality manual reviewed | Manager | <<FILL>> | <<FILL>> |
| 1.3 | EHS and site safety orientation completed | EHS | <<FILL>> | <<FILL>> |
| 1.4 | Initial GxP or cGMP foundations training assigned in the training system | Training / QA | <<FILL>> | <<FILL>> |
| 1.5 | Direct supervisor and the QA contact for the employee’s area are introduced by name | Manager | <<FILL>> | <<FILL>> |
2. Week one
| # | Item | Owner confirms | Complete (Y/N, date) | Notes |
|---|---|---|---|---|
| 2.1 | Employee has located the document control system and can independently look up and open a current SOP | Manager / Training buddy | <<FILL>> | <<FILL>> |
| 2.2 | Employee’s training matrix assignments are reviewed with them and confirmed correct for the actual role and tasks | Training / QA | <<FILL>> | <<FILL>> |
| 2.3 | Employee understands they may not perform an unsupervised GxP task until the relevant training record is complete and current | Manager | <<FILL>> | <<FILL>> |
| 2.4 | Gowning, hygiene, or area-specific access requirements are covered and, if applicable, gowning qualification is scheduled | EHS / QA | <<FILL>> | <<FILL>> |
| 2.5 | Employee has read the deviation management SOP and can describe, in their own words, when and how to raise a deviation | Manager / QA | <<FILL>> | <<FILL>> |
3. Days 2 to 30
| # | Item | Owner confirms | Complete (Y/N, date) | Notes |
|---|---|---|---|---|
| 3.1 | Role-specific procedure training is complete for every task the employee will perform in the first month | Training / QA | <<FILL>> | <<FILL>> |
| 3.2 | Employee has shadowed an experienced colleague on each core task at least once before performing it themselves | Manager | <<FILL>> | <<FILL>> |
| 3.3 | Employee can identify, by name or role, who in Quality dispositions the product or process they work on, and can explain why that person and not Production holds that authority | Manager / QA | <<FILL>> | <<FILL>> |
| 3.4 | Employee has observed or been walked through an actual deviation record, from initiation to closure | QA | <<FILL>> | <<FILL>> |
| 3.5 | Any function-specific qualification requirement (analyst qualification, gowning qualification, operator qualification) is scheduled with a target date | Training / QA | <<FILL>> | <<FILL>> |
4. Days 31 to 60
| # | Item | Owner confirms | Complete (Y/N, date) | Notes |
|---|---|---|---|---|
| 4.1 | Employee performs core job tasks under direct supervision, with second-person verification on any critical step | Manager | <<FILL>> | <<FILL>> |
| 4.2 | Employee has attended or observed a deviation, CAPA, or quality meeting relevant to their area | Manager / QA | <<FILL>> | <<FILL>> |
| 4.3 | Employee can describe the escalation path for a quality or safety concern, including who to contact if their own supervisor is unavailable | Manager | <<FILL>> | <<FILL>> |
| 4.4 | Any function-specific qualification scheduled in month one is complete or has a documented revised date | Training / QA | <<FILL>> | <<FILL>> |
| 4.5 | 30/60-day check-in conversation held; any training or performance gap documented with a plan | Manager | <<FILL>> | <<FILL>> |
5. Days 61 to 90
| # | Item | Owner confirms | Complete (Y/N, date) | Notes |
|---|---|---|---|---|
| 5.1 | Employee performs core job tasks independently, within the scope they are trained and qualified for | Manager | <<FILL>> | <<FILL>> |
| 5.2 | Full training record reviewed end to end and confirmed current against the training matrix, with no overdue items | Training / QA | <<FILL>> | <<FILL>> |
| 5.3 | Employee has successfully raised, or role-played raising, at least one deviation or quality observation | Manager / QA | <<FILL>> | <<FILL>> |
| 5.4 | Any outstanding qualification (analyst, operator, gowning) is complete | Training / QA | <<FILL>> | <<FILL>> |
| 5.5 | 90-day check-in held with manager and, where practical, QA; overall readiness assessed | Manager | <<FILL>> | <<FILL>> |
90-day sign-off
| Field | Entry |
|---|---|
| Training record status | <<FILL: current / gaps listed>> |
| Outstanding items | <<FILL: none, or list with target dates>> |
| Overall readiness | <<FILL: ready for independent work / conditional / extend orientation>> |
| Role | Name | Signature | Date |
|---|---|---|---|
| Employee | <<FILL>> | ||
| Manager | <<FILL>> | ||
| Training / QA | <<FILL>> |
References
21 CFR 211.25 (personnel: education, training, and experience to perform assigned functions). ICH Q10, Pharmaceutical Quality System (training and competence as part of the quality management system). EU GMP Part I, Chapter 2 (Personnel).
Confirm the current version and clause numbers of each reference before issue, and align this checklist with the site’s own training and qualification procedures.
Filled specimen
Illustrative extract for a new QC analyst joining a small-molecule release testing laboratory.
| # | Item | Complete | Notes |
|---|---|---|---|
| 1.4 | Initial GxP training assigned | Yes, 03 Aug 2026 | Foundations module and lab-specific data integrity module both assigned same day |
| 2.1 | Located document control system, opened a current SOP unassisted | Yes, 05 Aug 2026 | Confirmed with training buddy; pulled the correct current version of the HPLC method SOP on the second attempt |
| 3.3 | Can identify who dispositions product | Yes, 20 Aug 2026 | Correctly named the QA batch reviewer and explained the separation between QC testing and QA disposition |
| 4.1 | Core tasks under supervision with second-person verification | Yes, 10 Sep 2026 | Ran three release assays under direct oversight; one result flagged for a documented calculation check |
| 5.2 | Training record reviewed, confirmed current | Yes, 28 Oct 2026 | One overdue module (electronic signature refresher) identified and closed before sign-off |
The sequence above is the pattern this checklist is built to produce: real evidence at each milestone, a caught gap (the overdue refresher module) fixed before the 90-day sign-off rather than after, and a new analyst who can explain the QC/QA separation in their own words rather than repeat it from a slide.
Common inspection findings this checklist prevents
- An employee performing unsupervised GxP work before their training record shows the relevant procedure as complete.
- Training records that do not match the tasks the person is actually observed doing.
- A new hire who cannot explain who dispositions the product they work on, or who believes they can self-approve their own work.
- Orientation that covers safety and badge access but never actually walks the employee through the document control system or the deviation process.
- No documented 90-day readiness confirmation, so “the person seems fine” substitutes for an evidenced training record.
How to adapt this checklist
- Set the employee, role, and owners in the control block.
- Add role-specific qualification items (analyst qualification, operator qualification, gowning qualification) where the generic items are not enough.
- Shorten or extend the 90-day horizon to match your site’s own probationary or qualification period.
- Tie item 3.3 and 5.3 to your actual deviation and disposition procedures so the employee is learning your real process, not a generic description of one.
- Confirm every regulation and chapter reference in the References section against the current published version before issue.