Templates and records · ISO 22716 · Clause 15
ISO 22716 change control request template
Changing a raw material supplier, a piece of equipment or a procedure can affect the product. Change control forces you to assess and approve it beforehand, not discover it afterwards.
In one sentence
The change control request describes a change that could affect product quality — formula, raw material, supplier, equipment, process, specification or document — assesses its impact with sufficient data, records approval by authorised staff and lists the documents to be updated, because ISO 22716 recommends that such changes be approved and implemented by authorised people on the basis of sufficient data (chapter 15).
- Where the standard requires it
- ISO 22716 · Clause 15 Chapters are those of ISO 22716:2007, the only edition published, confirmed by ISO in 2022. It is a guidelines standard: it recommends; the obligation comes from Article 8 of Regulation (EC) 1223/2009.
- Type of information
- Mandatory record ISO 22716 recommendation (15 and 17.4), enforceable through Article 8 of Regulation 1223/2009
- Who fills it in
- The proposer and quality The area wanting the change proposes it; quality and technical assess it; authorised staff approve it
- When
- Before the change is implemented And it is closed once documents are updated and the outcome has been checked
- How long it is kept
- Defined by the company ISO 22716 asks for the archiving period to be set according to applicable legislation (17.5.2). As a reference, the product information file is kept for ten years after the last batch was placed on the market (Article 11(1) of Regulation 1223/2009).
What the standard requires
What ISO 22716 demands and what it leaves to your judgement
Chapter 15 amounts to a single sentence: changes that could affect product quality are approved and implemented by authorised staff, on the basis of sufficient data. What it leaves to the company is the procedure.
The documentation chapter completes the idea: documents are updated when needed, the revision number is shown and the reason for each revision is kept (17.4). In subcontracting, the contract acceptor must give notice before any change that could affect quality (12.4.4).
A change of formula or raw material may also require the safety assessment and the product information file required by Regulation 1223/2009 to be updated (Articles 10 and 11).
Structure
Fields the template should include
- Number, date and requester
- Description of the change and reason
- Type: formula, raw material, supplier, equipment, process, specification, document
- Products and batches affected
- Assessment of the impact on product quality and safety
- Supporting data: tests, pilot batches, stability
- Impact on the product information file and the safety assessment
- Approval by authorised staff
- Documents updated and their new version
- Communication to contract manufacturing customers, where applicable
- Post-change verification and closure
Example
Example: second supplier for an emulsifier
Company, people and figures are fictitious: the example only shows what a properly completed record looks like.
| Field | Content |
|---|---|
| Number | CC-2026-009 · 12 February 2026 · purchasing |
| Change | Approve a second supplier of Cetearyl Alcohol due to the risk of shortage |
| Affects | Moisturising cream CH-30 and two other products |
| Impact | Medium: same chemical specification, possible difference in final viscosity |
| Data | New supplier's certificate and specification; 20 kg pilot batch with conforming viscosity and pH; 3-month accelerated stability conforming |
| File | The safety assessor confirms the assessment does not change |
| Approval | Quality manager, 20 May 2026 |
| Documents | Specification RM-0117 version 4 with both suppliers · approved supplier list |
| Verification | First 3 industrial batches with the new supplier conforming · closed on 30 June |
At the audit
Mistakes auditors commonly flag
- Raw material supplier changes decided by purchasing without going through quality.
- The change is approved with no data, on the supplier's word alone.
- The change is implemented, but documents remain at the previous version.
- Nobody checks whether the change affects the product information file.
- Contract manufacturing customers find out about the change through a complaint.
In Kimobox
How this record is kept in Kimobox
- 1Each change is processed as a form with its approval workflow by authorised staff.
- 2The GMP documents affected are managed with version control and the reason for each revision.
- 3The change's tasks are assigned with an owner and a date, with a warning if they slip.
- 4The change is linked to the products and batches it applies to, visible in their traceability.
Frequently asked questions
What people ask us before getting started
Which changes need change control?
Those that could affect product quality: formula, raw materials and their suppliers, packaging materials, equipment, process parameters, test methods, specifications and premises. Changes with no impact can follow a simplified route, but they are still worth recording.
How does it differ from a deviation?
A deviation is a one-off departure from what is planned; change control deals with a permanent modification. If the same deviation is authorised again and again, it is really a change that should have been approved as such.
Does it affect the product information file?
It can. A change of formula, raw material or process may require the safety assessment and the product information file to be updated. That is why the request should ask about it explicitly.
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Sources
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- ISO 22716:2007 — Cosmetics. Good Manufacturing Practices (GMP). Guidelines on Good Manufacturing Practices ISO · 2007 ed., confirmed in 2022
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products EUR-Lex · 30 November 2009, consolidated text