| SOP | WIN | AA Doc ID | Type | Frequency | Description (Purpose, Scope & Audit Focus) |
|---|---|---|---|---|---|
| SOP-TAL-TRAIN | |||||
| WIN-TAL-TRAIN-ASSIGN | AA-REC-TAL-TRAIN-ASSIGN-EVT | REC | Per Role / SOP |
Purpose: Document assignment of required training based on role and SOP applicability. Scope: All personnel performing GMP-related activities. Auditor Focus: Training assignments aligned to job responsibilities. |
|
| WIN-TAL-TRAIN-COMPLETE | AA-REC-TAL-TRAIN-COMPLETE-EVT | REC | Per Training |
Purpose: Provide objective evidence of training completion. Scope: All assigned training events. Auditor Focus: Timely completion prior to independent work. |
|
| SOP-TAL-COMP | |||||
| WIN-TAL-COMP-EVAL | AA-FRM-TAL-COMP-EVAL-EVT | FRM | As Required |
Purpose: Formally evaluate personnel competency for GMP roles. Scope: Roles requiring demonstrated skill or judgment. Auditor Focus: Objective competency assessment criteria. |
|
| WIN-TAL-COMP-APPROVE | AA-REC-TAL-COMP-APPROVAL-EVT | REC | Per Evaluation |
Purpose: Document approval of competency determinations. Scope: Competency evaluations requiring management or QA approval. Auditor Focus: Authorization supported by documented evaluation. |
|
| SOP-TAL-QUAL | |||||
| WIN-TAL-QUAL-INITIAL | AA-CHK-TAL-QUAL-INITIAL-EVT | CHK | Initial Qualification |
Purpose: Verify readiness for independent GMP role performance. Scope: Personnel seeking initial role authorization. Auditor Focus: Qualification completed before unsupervised work. |
|
| WIN-TAL-QUAL-MAINTAIN | AA-LOG-TAL-QUAL-STATUS-APR | LOG | Ongoing |
Purpose: Track qualification and authorization status over time. Scope: All qualified GMP personnel. Auditor Focus: Current authorization status and requalification tracking. |
|