GMP qualification

Training Coordinator creates a staff assignment for an employee, organization and controlled training module. The module has a code, effective dates and policy reference. The assignment carries its own number, revision, owner, site code, GMP version, required passing score, assessment score, completion information and qualification expiry. The status shows whether work is assigned, in progress, assessed, qualified or expired.

GMP Qualification Overview presents the pipeline by training module and site, including pending starts and qualified completions. Training Coordinator can use it to identify an employee who has an assignment but has not begun. GMP Reviewer can inspect the same assignment’s evidence before making a decision. A summary view supports triage; the linked source records remain the place to inspect the actual assessment.

• Controlled definition. Choose the active module version and organization before assigning training.
• Evidence. Keep training lines, source references and supporting documents attached to the assignment.
• Review. Record the reviewer, decision, reason and assignment revision for a specific qualification judgment.

Agree which modules apply to each role and site, who owns assignments and who serves as independent reviewer. Define passing score and expiry rules before a qualification is used for staffing decisions. The assignment has both completion date and completed at information; agree which one represents the business completion event and record it consistently.

A GMP training line can hold an observation date, outcome, training hours, score, version and source record identifier. Evidence documents can hold a document date, attachment, external reference and verification. Review decisions can be pending, approved, returned or rejected. A returned decision should state what needs correction, and the follow-up action should name an assignee and due date.

A manufacturing employee is assigned a controlled module for a specific site. Training Coordinator checks the employee and active module, records the owner and site code, and moves the assignment into progress when learning begins. The coordinator adds a training line with the assessment score and source reference, then attaches supporting evidence. The reviewer compares the score with the passing score and checks the evidence against the assignment revision.

If the evidence is sufficient, GMP Reviewer records approval and Training Coordinator records the qualified state and expiry. If a source document needs correction, the reviewer returns the decision with a reason. Training Coordinator opens a follow-up action for the responsible person. Training Coordinator records the status transition and actor in the history, then presents the corrected revision for another review.

• GMP assignment board — Assignment status, employee, controlled module, organization and owner in one worklist.
• GMP review inbox — Pending decisions with the linked assignment revision.
• Open training follow-up — Remediation with assignee and due date.

Run GMP training qualification and prepare its implementation rehearsal with a real assignment.