Master Manufacturing Record (MMR) — MASTER INDEX

This MASTER file defines the controlled MMR set (modules), global product identity, and governance. Manufacturing stages may be executed non-contiguously.

1. Document Control

MMR ID

MASTER Version

Product Specification ID

Formulation Sheet ID

Document Owner / Department

Effective Date

Supersedes

Change Control / Revision Ticket (if applicable)

Controlled Copy Statement: This document is a controlled MASTER. Printed copies are uncontrolled unless stamped “CONTROLLED COPY”. Edits to controlled content require change control and re-approval. Approved execution uses controlled BPRs and/or approved PDF outputs.

2. Product Information

Product Name

Dosage Form

Strength per Serving

Servings per Container

Batch Size (Target)

Lot Number Format (Finished Goods)

Regulatory Classification

3. Manufacturing Stage Modules — Control Table

This table defines the official module set for this MMR. Only modules marked APPROVED may be executed. If a module is DRAFT, that stage cannot be executed until approved.

Stage	Module Document ID	Version	Status	Effective Date	Approval Reference (QA or Doc Control ID)
Pre-Weigh
Blending / Bulk Prep
Dosage Form Step
Packaging

4. Stage Execution & Packaging Readiness Policy

Non-contiguous execution allowed: Manufacturing stages may be executed independently (e.g., Pre-Weigh and Blending completed prior to Packaging). Each stage execution must follow the currently APPROVED module version at time of execution, and be documented on the associated BPR.

PW/BL/EN may execute when their modules are APPROVED, even if Packaging remains DRAFT.
Packaging may NOT execute until the Packaging module is APPROVED and label/packaging components are released.
Module updates do not retroactively alter previously executed and QA-reviewed BPRs.
Any change impacting identity/strength/label claims requires QA review and change control before execution.

5. Lot Genealogy & Traceability Rules

Define how lots flow across stages to maintain end-to-end traceability.

Raw Material Lot Recording Requirement

Intermediate / Bulk Lot Format (if used)

WIP / Dosage-Form Lot Format (if used)

Packaged Finished Lot Format

Genealogy Rule (simple statement)

6. Hold / Release Gates

Gate	Trigger	Responsible
Line Clearance	Before each stage execution	QA or Designee
WIP Release to Next Stage	After stage completion + reconciliation	QA
Packaging Release	Packaging module approved + components released	QA
Final Product Release	All testing met + deviations closed	QA

7. Stage Yield Targets (Expected)

Define expected yields/ranges by stage (actuals captured in BPRs). This supports investigations and reconciliations.

Stage	Yield Basis	Expected Range	Reference
Pre-Weigh	Dispensed mass vs theoretical
Blending / Bulk Prep	Bulk mass vs dispensed mass
Dosage Form Step	Units produced vs theoretical
Packaging	Packaged units vs issued WIP

8. Revision History

Version	Date	Description of Change	Change Control ID
1.0		Initial release of MASTER index and governance.

9. Approval (Wet Signature)

Prepared By	Reviewed By	QA Approval	Date

Note: Each Stage Module (PW/BL/EN/PK) must also carry its own approval block. Execution must reference the approved module version in effect at the time of execution.