MARKETING QMS FAMILY PACK

Table of Contents

Section 1 - Family Summary

This Family inherits all governance defined in the Unified Governance Manual (SOP-QMS-GOV), including the Quality Manual, Risk Management Program (RMP), Internal Audit Program (IAP), and Material Review Board (MRB) governance.

The Marketing (MKTG) Process Family governs WHAT-level requirements for external representation of products and capabilities by a contract dietary supplement manufacturer.

As a non-brand manufacturer, MARKETING does not originate, own, optimize, or approve product benefit claims. MARKETING is accountable for preventing prohibited, misleading, or unsupported claims from entering manufacturing operations.

MARKETING may promote only:

MARKETING is explicitly prohibited from:

Risk Tier Classification: HIGH. Misrepresentation of claims or formats may constitute misbranding and trigger FDA or FTC enforcement independent of manufacturing quality.

Section 2 - Purpose, Scope & Regulatory Anchors

This section establishes controls ensuring marketing activity does not exceed authorized manufacturing capability or regulatory allowance.

SOP ID SOP Title Purpose (Control Intent) Scope (Operational Boundary) Regulatory Reference
SOP-MKTG-CLAIMS Customer Claim Intake, Risk Review & Control Prevents prohibited or misleading claims from entering manufacturing. Applies to all customer-owned claims referenced in marketing, SALES, PMAs, SOWs, or specifications. 21 CFR 111 (misbranding); FTC Truth-in-Advertising
SOP-MKTG-FORMAT Product Format Representation Control Ensures only QA-authorized dosage forms and packaging formats are externally represented. Applies to all references to physical product formats. 21 CFR 111.60, 111.70; NSF/ANSI 455-2
SOP-MKTG-CONTENT Marketing Content Review & Release Prevents release of unapproved or misleading content. Applies to all externally facing marketing materials. NSF/ANSI 455-2 Documentation Controls

Section 3 - General Training Requirements

Section 4 - Segregation of Duties & Accountability

Decision / Activity MARKETING SALES QA
Originate product benefit claims Prohibited Prohibited Prohibited
Accept customer claims for review Accountable Initiate Review / Block
Approve or reject claims Prohibited Prohibited Accountable
Commit claims to customers Prohibited Accountable (within approved scope) Authorize
Stop manufacturing due to claim risk Escalate Escalate Accountable

Accountability is assigned based on decision ownership. Accountability may not be transferred between functions.

Section 5 - Required AAs & Traceability Matrix

SOP WIN Auditable Artifact (AA) Evidence Intent
SOP-MKTG-CLAIMS WIN-MKTG-CLAIMS-RISK AA-REC-MKTG-CLAIMS-RISK Claim classification and acceptance decision
SOP-MKTG-FORMAT WIN-MKTG-FORMAT-VER AA-CHK-MKTG-FORMAT-REL Verification of authorized format
SOP-MKTG-CONTENT WIN-MKTG-CONTENT-REL AA-REC-MKTG-CONTENT-REL Approved marketing content

Section 6 - AA Deliverable Requirements

CLAIM CLASSIFICATION (Select One):

[ ] Prohibited Claim (Reject / Block Manufacturing)
[ ] Customer-Owned Claim (Conditional Acceptance)
[ ] Manufacturer-Originated Factual Statement

VERIFICATIONS:

[ ] Claim does not constitute disease or drug claim
[ ] Claim documented in PMA / SOW
[ ] Required disclaimers present
[ ] QA review completed
[ ] Manufacturing blocked if unresolved

Marketing Owner: ______  Date: ______
QA Reviewer: _________  Date: ______

Section 7 - WIN Layer (High-Level Operational HOW)

WIN-MKTG-CLAIMS-RISK

  1. Claim received from customer or SALES.
  2. Claim classified (Prohibited / Conditional / Manufacturer).
  3. QA reviews risk and acceptance.
  4. Manufacturing proceeds or is blocked.
  5. Decision recorded.

WIN-MKTG-FORMAT-VER

  1. Format referenced in content.
  2. Format verified against authorized list.
  3. Unverified formats blocked.
  4. QA escalation if unclear.
  5. Evidence recorded.

Section 8 - Governance Inheritance

This Family Pack operates fully within enterprise governance. Acceptance of customer claims does not constitute endorsement, authorship, or regulatory approval by the manufacturer.