Can I just use these templates as-is for FDA compliance?

These templates are designed to meet 21 CFR 111 documentation requirements, but they're starting points. You need to fill them in with your actual product data, testing results, and approvals. They provide the structure — you provide the content. FDA won't accept a blank template; they want a completed, signed, dated document specific to your product.

Do I need all three templates?

The specification sheet (Template 1) is legally required under 21 CFR 111.70. The COA request form (Template 2) is practical but not legally required — it just makes your lab interactions smoother. The batch record checklist (Template 3) is good GMP practice and makes release decisions systematic, but the format is flexible as long as you capture the required information.

Can I edit these templates?

Yes. These are starting points. Add tests, remove tests that don't apply to your product, adjust formatting for your workflow. The content matters more than the exact format. Just make sure you don't remove anything that's legally required (identity, potency, metals, microbial for finished product specs).

What about specifications for raw materials?

Template 1 is for finished products. Raw material specifications follow a similar format but reference the supplier's COA specifications, include identity testing results (which may be from your own lab or a qualified supplier's lab), and don't include physical characteristics like disintegration. You can adapt Template 1 for raw materials by removing the physical section and changing the references.

How long do I need to keep these records?

21 CFR 111.475 requires you to keep batch production records for at least one year past the shelf life date of the batch, or two years from the date of distribution, whichever is longer. In practice, keep everything for at least three years. Specifications and testing programs should be kept indefinitely as controlled documents with revision history.

Free Supplement Spec & COA Templates (21 CFR 111.70)

Every supplement brand needs these documents. Every FDA inspector asks for them. Almost nobody has them ready when they start.

I'm giving you three templates. Copy them. Fill them out. Keep them in your batch records. When the FDA asks, you hand them over.

Template 1: Finished Product Specification Sheet

This is your 21 CFR 111.70(e) specification document. One per product. Keep it in your batch records.

=================================================================
       FINISHED PRODUCT SPECIFICATION SHEET
=================================================================

Product Name: ________________________________________________
Product Code/SKU: ____________________________________________
Dosage Form: [ ] Tablet  [ ] Capsule  [ ] Powder  [ ] Liquid
              [ ] Softgel  [ ] Gummy  [ ] Other: ___________
Serving Size: ________________________________________________
Servings Per Container: ______________________________________
Container Type/Size: _________________________________________

=================================================================
SPECIFICATION                                                                     TEST METHOD                    ACCEPTANCE CRITERIA
=================================================================

IDENTITY
--------
Ingredient 1: _____________________            ________________________           Matches reference standard
Ingredient 2: _____________________            ________________________           Matches reference standard
Ingredient 3: _____________________            ________________________           Matches reference standard

POTENCY
-------
Active 1: _________________________            ________________________           ___% - ___% of label claim
Active 2: _________________________            ________________________           ___% - ___% of label claim
Active 3: _________________________            ________________________           ___% - ___% of label claim

PURITY / CONTAMINANTS
---------------------
Lead (Pb)                                       USP <2232> ICP-MS                 NMT ___ mcg/serving
Arsenic (As)                                    USP <2232> ICP-MS                 NMT ___ mcg/serving
Cadmium (Cd)                                    USP <2232> ICP-MS                 NMT ___ mcg/serving
Mercury (Hg)                                    USP <2232> ICP-MS                 NMT ___ mcg/serving

MICROBIAL LIMITS
----------------
Aerobic Plate Count                             USP <2021>                        NMT ___ CFU/g
Yeast & Mold                                    USP <2021>                        NMT ___ CFU/g
Escherichia coli                                USP <2022>                        Absent in 10g
Salmonella spp.                                 USP <2022>                        Absent in 25g
Staphylococcus aureus                           USP <2022>                        Absent in 10g

PHYSICAL CHARACTERISTICS
------------------------
Appearance:                  [ ] Conforms to reference sample
Odor:                        [ ] Conforms to reference sample
Color:                       [ ] Conforms to reference sample
Average Weight (per unit):   _____________ ± ___%
Disintegration (if tablets): USP <2040>     NMT ___ minutes
Water Activity (if gummies): ____________  NMT ___ Aw

=================================================================
SPECIFICATION BASIS

Potency specification is based on USP monograph for [ingredient],
validated for this product matrix by [Lab Name] on [Date].

Heavy metal limits are derived from USP <2232> Elemental Impurities
and California Proposition 65 Safe Harbor levels.

Microbial limits per USP <2021> and <2022> for non-sterile dietary
supplements.

=================================================================
APPROVALS

Prepared by: ________________________  Date: ____________
Reviewed by (QC): ____________________  Date: ____________
Approved by: _________________________  Date: ____________

=================================================================
Specification Number: SP-[PRODUCT CODE]-[REV]
Revision: _____   Effective Date: ____________
=================================================================

Free Supplement Specification & COA Templates

Template 1: Finished Product Specification Sheet

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