Start a pharmaceutical training-records review with the employee’s work: which operations will they perform, which procedures apply, and what evidence will your quality team review? Use the requirements and guidance below to develop your own records checklist.
- US drug CGMP training must be delivered by qualified individuals on a continuing basis, frequently enough to maintain familiarity with applicable CGMP requirements.
- Section 211.25 does not prescribe a list of training-record fields.
- Health Canada's GUI-0001 personnel guidance calls for maintaining training records.
- Keep recommended evidence fields separate from regulatory requirements.
Sources for the regulatory and guidance statements: 21 CFR 211.25 and GUI-0001. The final takeaway is a practical filing recommendation.
United States: what 21 CFR 211.25 requires
Each person manufacturing, processing, packing or holding a drug product must have the education, training and experience, or a combination of them, needed to perform their assigned functions. Training must cover the employee’s particular operations and CGMP, including applicable CGMP regulations and required written procedures as they relate to that employee’s functions. 211.25(a).
CGMP training must be provided by qualified individuals on a continuing basis and frequently enough to keep employees familiar with the requirements applicable to them. Paragraph (a) does not set an annual training interval. 211.25(a).
The section also requires an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing or holding of each drug product. 211.25(c).
Section 211.25 itself does not list mandatory training-record fields. 211.25(a)-(c). Practical recommendation: Do not treat that limited observation as permission to skip documentation; have your quality team determine the evidence and record controls needed for your operations.
Canada: distinguish the regulation from the guidance
Under Food and Drug Regulations C.02.006, every drug lot or batch must be fabricated, packaged/labeled, tested and stored, including during transportation, under supervision by personnel whose technical, academic or other training the Minister considers satisfactory, having regard to their duties and responsibilities and the health of the consumer or purchaser. Current C.02.006.
Health Canada’s GUI-0001 personnel interpretation calls for initial and continuing training relevant to job responsibilities and keeping training records. The guide is administrative guidance without the force of law. GUI-0001, introduction and personnel interpretation 6.
Practical recommendation: Identify which parts of your training procedure implement a legal requirement, which follow the applicable guidance, and which are your organization’s additional controls.
Build an evidence checklist around the source
| Source | What it says | Recommended supporting evidence |
|---|---|---|
| US 211.25(a), regulation | Personnel need education, training and experience, or a combination, sufficient for their assigned functions. | A role description linked to relevant qualifications and completed training. |
| US 211.25(a), regulation | Qualified individuals must deliver continuing CGMP training frequently enough to maintain familiarity with applicable requirements. | The training program, completion dates, instructor information and relevant content. |
| Canada C.02.006, regulation | Supervision must be by personnel whose training the Minister considers satisfactory in light of duties, responsibilities and consumer or purchaser health. | The responsible supervisor’s qualifications and assigned responsibilities. |
| Health Canada GUI-0001, guidance | Provide initial and continuing role-relevant training and maintain training records. | Records organized by employee and the work covered. |
Sources: 211.25, C.02.006 and GUI-0001.
Recommended fields for an internal checklist
Practical recommendation: Consider recording the employee, assigned function, procedure or material revision, training date, instructor, and any assessment used to check understanding. Keep this checklist separate from claims about mandatory fields in 211.25. Assign a record owner and document how your team will review gaps and training needs after a procedure changes.
For help organizing the workflow, see how to build a training matrix and organizing audit-ready training records.
Keeping supporting records in TrainGrid
TrainGrid lets permitted users attach a certificate or other file to a training record. User guide.
TrainGrid is not validated for 21 CFR Part 11. Whether a training-record workflow falls within Part 11 depends on the applicable FDA requirements and intended use, not only on electronic signatures. Do not rely on TrainGrid for records requiring Part 11 controls without establishing and validating the required controls for that use.