ISO 22716 Raw‑Material Specification Sheet Example

Last Updated on October 24, 2025 by Hafsa J.

Why Raw-Material Specifications Matter in ISO 22716 Compliance

If you’ve ever had a batch fail quality control and no one could tell if it was due to a raw ingredient, you know the panic that follows.
In my experience helping cosmetic manufacturers prepare for ISO 22716 audits, this is one of the most common — and preventable — issues.

Most problems start because of missing or vague raw-material specifications.
Someone assumes the supplier’s Certificate of Analysis is enough. It’s not.

Under ISO 22716, your Raw-Material Specification Sheet is the cornerstone of traceability and quality control. It defines what you expect from every ingredient that enters your facility — its identity, purity, safety, and storage conditions.

In this article, I’ll walk you through how to build one that actually works — not just to pass an audit, but to protect your products, your customers, and your brand.

Understanding Raw-Material Control in ISO 22716

Here’s what ISO 22716 really wants to see: control from the moment a material is ordered to the day it’s used in production.

That means you must know:

• Where it came from
• What it is
• How it behaves
• And whether it meets your defined quality standards

The specification sheet is your reference document. It’s what purchasing, warehouse, and QC all look at when deciding if a shipment should be accepted or rejected.

Pro tip: Treat it like a live document, not a static form. Update it when a supplier changes source, when your product formula evolves, or when you adjust your risk profile.

Common mistake: Simply copying data from a supplier’s COA. Remember — that COA proves their compliance, not yours. Your sheet must define your own acceptance criteria.

Essential Sections of a Raw-Material Specification Sheet

Every good specification sheet tells the full story of your ingredient — from chemical identity to microbiological safety. Here’s how to structure it.

1. Material Identification

Include the material name, internal code, INCI name, CAS number, and supplier name.
If it’s used in multiple products, note that too.
This prevents confusion during audits and in-process traceability.

2. Physical & Chemical Characteristics

Describe what the material should look, smell, and feel like.
List measurable ranges — color, pH, density, purity.
Pro tip: Keep parameters realistic; don’t set ranges you can’t verify in your own lab.

3. Microbiological Specifications

For ingredients like botanical extracts or powders, define acceptable microbial limits.
Even if you outsource testing, you’re still accountable for results.

4. Storage & Handling Conditions

Specify how the material should be stored — temperature, humidity, and packaging.
This is where most contamination starts if conditions aren’t respected.

5. Packaging Information

State container type, size, and labeling requirements.
Make sure the packaging protects against light, air, or moisture if applicable.

6. Quality Control & Testing

Describe your testing plan — what’s tested, how often, and by which method.
Reference ISO or pharmacopeia methods when relevant.

7. Approval & Revision History

Track version number, issue date, and signatures of QA approval.
Pro tip: Use digital version control — it prevents old data from resurfacing later.

Building Traceability: How Specification Sheets Connect with GMP Records

Your raw-material specification isn’t a stand-alone file — it’s the anchor document connecting several GMP systems.

It links directly to:

• Supplier qualification records
• Incoming inspection logs
• Batch production records
• Change-control forms

This is how auditors trace back from a finished product to the raw material that went into it.

Pro tip: Use one consistent internal code across all documents — from supplier approval to production.
Common pitfall: Having supplier codes that don’t match your internal numbering. It creates confusion fast, especially during traceability checks.

Managing Supplier Data & Change Control

Your specification sheet is only as reliable as your supplier information.
That’s why maintaining and updating supplier data is part of ISO 22716 compliance.

Here’s how to manage it:

• Review supplier COAs annually
• Re-approve suppliers when there’s a source change or new certificate
• Note any updates directly in the “Revision History” section

Pro tip: Schedule an annual supplier-data review and make it part of your internal audit program.
Example: One cosmetic brand I worked with caught a potential allergen issue early when their supplier changed glycerin origin — because their revision log forced a review before approval.

Example: Raw-Material Specification Sheet Layout

Here’s what a compliant layout looks like in practice:

Section	Example Entry
Material Name	Glycerin USP
Internal Code	RM-GLY-01
Supplier	ABC Chemicals Ltd.
INCI Name	Glycerin
Physical Form	Clear, viscous liquid
Purity	≥ 99.5 %
pH	5.5 – 7.0
Microbial Limits	< 100 cfu/g total count
Storage	20–25 °C, sealed container
COA Reference	COA-GLY-2025-001
Approved By	QA Manager – 10 Oct 2025

This layout is clean, clear, and audit-friendly.
Pro tip: Never let supplier COA values dictate your acceptance range — you define the range that aligns with your risk and process needs.

Maintaining & Reviewing Specification Sheets

A lot of manufacturers forget that these documents expire — just like raw materials do.
Specification sheets should be reviewed:

• Every 12 months
• After a formula or supplier change
• After significant regulation updates

Pro tip: Use your document-control system to set automatic review reminders.
Example: A skincare company I helped switched to digital templates and reduced missing COAs by 80 %. One automated email each quarter made the difference.

Common mistake: Forgetting to re-approve updated versions. Outdated specs can cause a chain of non-conformities that’s painful to untangle later.

FAQs: Raw-Material Specification Sheets & ISO 22716

Q1. Are raw-material specification sheets required by ISO 22716?
Yes. They prove that each raw material meets defined quality, purity, and safety criteria before use.

Q2. How often should we update our specification sheets?
At least annually, or any time there’s a supplier or formulation change.

Q3. Can we just attach the supplier’s COA instead?
No. COAs support your own specifications — they don’t replace them. The COA confirms one batch meets your standards; the specification defines what those standards are.

Build Quality at the Source

Raw-material control is where true quality begins.
In my experience, companies that master this step rarely struggle during audits — because everything else flows from it: batch consistency, supplier reliability, and product safety.

Don’t wait for your next inspection to fix gaps.
Take a few hours to build or update your specification sheets — and you’ll strengthen both compliance and confidence across your operation.

Ready to get started?
Download our ISO 22716 Raw-Material Specification Sheet Template and tailor it to your product line today.