SNL Product Specification Form (FRM-SALES-SPEC-01)

Customer & Product Information
Formula Information

Active Ingredients (Claim-Level Only)

List each active ingredient with the labeled amount per serving. Do not include manufacturing weights or batch-level data.

Active Ingredient Label Claim Amount (per serving) Extract Ratio / Standardization Function / Claim Driver

Excipients (Functional Disclosure Only)

List excipients and their functional roles. Do not include mg weights or internal BOM data.

Excipient Functional Role Customer Restrictions

Formula Constraints & Sensitivities

Flowability & Handling

Customer-visible summary only. Internal density and flow performance are validated internally.

Customer-Approved Overages (If Applicable)

Only include overages that must be disclosed or approved by the customer.

Ingredient Overage (%) Reason
Capsule Requirements
Packaging Requirements

Define the final packaging configuration. Commercial terms (MOQ, lead times, etc.) are captured in the SOW.

Labeling & Artwork Requirements

Labeling expectations and artwork details. Commercial artwork timelines belong in the SOW.

All structure/function claims must comply with FDA 21 CFR 101.93 and require approval prior to artwork release.

Finished Product Quality Attributes

Examples: capsule intact with no splits or cracks; uniform color; no speckling; surface smooth; no excess powder leakage; free of contamination.

Microbial limits must meet the strictest regulatory requirement of all selected market regions unless otherwise specified and approved.

Storage & Shelf-Life Requirements
Identity & Testing Acceptance Criteria

Defines acceptance criteria for finished product release per 21 CFR 111.70(e) and NSF/ANSI 455-2.

Each dietary ingredient will undergo identity testing in accordance with 21 CFR 111.70 and 111.75 using FTIR unless an alternative approved method is required.

Finished Product Specifications
Required by 21 CFR 111.70(e) and NSF/ANSI 455-2. Defines release criteria for the finished product.

Reference Standard: Thermo Fisher Scientific certified FTIR spectral library (or approved customer-specified reference).

Attribute Specification Test Method Acceptance Criteria
Identity
Potency (Strength)
Purity
Composition Formula Verification No deviations from approved formula
Appearance Visual Inspection
Microbial Limits USP <61>, <62>
Heavy Metals ICP-MS
Disintegration (if applicable) USP
Weight Variation Weight Check
Count Variance Count Verification
Packaging Appearance Acceptance Criteria

Defines visually inspectable packaging acceptance standards.

Unacceptable Conditions Include:
  • Container dents, cracks, deformation, or punctures
  • Label wrinkles, tears, bubbles, or misalignment
  • Missing or partially applied induction seal
  • Foreign material inside container or under label
  • Smudged, incomplete, or incorrect printed information
  • Excessive powder leakage or residue
  • Discoloration or visible contamination
Addendum — Specification Boundaries & Responsibilities
Defines what belongs in the Product Specification versus the RFQ, SOW, PMA, and MMR.

Product Specification Includes:

RFQ Includes:

SOW Includes:

MMR Includes:

Where conflicts arise, the Product Specification controls unless superseded by formal change control.

MMR Integration Control Panel

📘 Product Specification Control Panel

This Product Specification is the authoritative source for all formulation, packaging, quality, documentation, and manufacturing requirements. All dependent documents must reference this version.

General Specification Governance

• All changes to this Product Specification must be executed through formal Change Control per SOP-QMS-ChangeControl.
• Identity of each dietary ingredient will be confirmed per component using approved analytical methods (default FTIR) in accordance with 21 CFR 111.70 and 111.75.
• Potency acceptance criteria apply per analyte and are governed by internal formulation controls (F-BOM) and release testing requirements defined in the MMR.
• Microbial limits will meet the strictest applicable regulatory standard of the Customer’s selected markets unless otherwise specified and formally approved.

✅ MMR Required Fields Checklist

All fields below must be completed before an MMR can be generated. These represent the minimum FDA 21 CFR 111.210 (a–h) and NSF 455-2 requirements.

  • Product Name
  • Project Code
  • Specification ID
  • Specification Version
  • Declared Serving Size
  • All Active Ingredients (label claim values)
  • All Excipients (functional role)
  • Capsule Size
  • Capsule Type
  • Count per Package
  • Primary Packaging Type
  • Appearance Specification
  • Odor Specification
  • Potency Acceptance Range
  • Microbial Specification
  • Heavy Metals Limits
  • Moisture Content Specification
  • Capsule Weight Variation Acceptance
  • Count Variance Acceptance
  • Storage Conditions
  • Shelf Life (months)
  • Servings per Bottle

When all items above are complete, the MMR automation engine will be able to generate a fully compliant Master Manufacturing Record with no missing data.

🔎 MMR Readiness Panel

Validate whether all required fields are complete before generating the MMR payload.

📄 Linked Document Status Dashboard

These documents reference this Specification. They must not contain independent specifications.

Document ID Version Status Effective Date Notes
SOW
F-BOM
MMR

Document Dependency Rule:
This Specification supersedes all previous versions.
The SOW, Formulation Sheet, MMR, and BPR must not contain independent or conflicting specifications.