| SOP | WIN | AA Doc ID | Type | Frequency | Description (Purpose, Scope & Audit Focus) |
|---|---|---|---|---|---|
| SOP-SALES-COMM | |||||
| WIN-SALES-CUSTCOMM | AA-CHK-SALES-CUSTCOMM-REL | CHK | Per Communication |
Purpose: Ensure customer communications are QA-reviewed prior to release. Scope: All GMP-related customer communications. Auditor Focus: QA approval and content control. |
|
| WIN-SALES-CUSTCOMM | AA-REC-SALES-CUSTCOMM-REL | REC | Per Communication |
Purpose: Retain finalized, approved customer communications. Scope: All approved outbound communications. Auditor Focus: Traceability to QA approval. |
|
| SOP-SALES-SPEC | |||||
| WIN-SALES-SPEC-CTRL | AA-CHK-SALES-SPEC-APR | CHK | Per Specification |
Purpose: Verify customer specification completeness and approval. Scope: All customer product specifications. Auditor Focus: Approved specifications governing manufacture. |
|
| WIN-SALES-SPEC-CTRL | AA-REC-SALES-SPEC-APR | REC | Per Specification |
Purpose: Maintain approved customer specifications. Scope: Specifications used for GMP execution. Auditor Focus: Controlled, current specifications. |
|
| SOP-SALES-RFQ | |||||
| WIN-SALES-RFQ-REL | AA-CHK-SALES-RFQ-REL | CHK | Per RFQ |
Purpose: Evaluate feasibility, capability, and QA impact. Scope: All customer RFQs. Auditor Focus: Risk-based feasibility review. |
|
| WIN-SALES-RFQ-REL | AA-REC-SALES-RFQ-REL | REC | Per RFQ |
Purpose: Document RFQ approval or rejection. Scope: RFQ decision outcomes. Auditor Focus: Justified acceptance decisions. |
|
| SOP-SALES-PMA | |||||
| WIN-SALES-PMA-APR | AA-CHK-SALES-PMA-APR | CHK | Per Agreement |
Purpose: Verify PMA completeness and approval. Scope: Product Manufacturing Agreements. Auditor Focus: GMP responsibility clarity. |
|
| WIN-SALES-PMA-APR | AA-REC-SALES-PMA-APR | REC | Per Agreement |
Purpose: Retain executed PMAs. Scope: Customer manufacturing agreements. Auditor Focus: Defined GMP responsibilities. |
|
| SOP-SALES-SOW | |||||
| WIN-SALES-SOW-APR | AA-CHK-SALES-SOW-APR | CHK | Per SOW |
Purpose: Verify scope, roles, and approvals. Scope: Statements of Work. Auditor Focus: Alignment with quality agreements. |
|
| WIN-SALES-SOW-APR | AA-REC-SALES-SOW-APR | REC | Per SOW |
Purpose: Maintain approved SOWs. Scope: Commercial execution documents. Auditor Focus: Controlled scope documentation. |
|
| SOP-SALES-ROE | |||||
| WIN-SALES-ROE-CTRL | AA-CHK-SALES-ROE-CTRL | CHK | Ongoing |
Purpose: Verify compliance with customer interaction rules. Scope: All customer-facing activities. Auditor Focus: Controlled communications. |
|
| WIN-SALES-ROE-CTRL | AA-REC-SALES-ROE-CTRL | REC | As Applicable |
Purpose: Document controlled customer interactions. Scope: Regulated customer engagements. Auditor Focus: Evidence of compliance. |
|