Templates and records · ISO 22716 · Clause 8.2

ISO 22716 cosmetic finished product release record

The last check before the market: someone in quality reviews the batch record and its results and decides, with their signature, whether the product goes out.

In one sentence

The finished product release record captures the review of the manufacturing and packaging batch records, the control results against the acceptance criteria, the retained sample kept and the decision — release, reject or hold — by authorised quality staff, because ISO 22716 recommends that all finished product be controlled before being placed on the market and released by quality staff (8.2), with retained samples kept in their primary packaging (9.8).

Content reviewed on 17 October 2026

Where the standard requires it: ISO 22716 · Clause 8.2 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 (8.2, 9.4 and 9.8), enforceable through Article 8 of Regulation 1223/2009
Who fills it in: Authorised quality staff Authorisation to release must be defined and independent of production
When: Before the batch is dispatched The batch stays in quarantine until the decision
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

Before being placed on the market, finished product must be controlled using established test methods and meet the acceptance criteria, and release is carried out by authorised quality staff. All results are reviewed and a decision is taken to approve, reject or hold (9.4).

Retained samples of the finished product must be kept in their primary packaging, in a designated area, for an appropriate time and in sufficient quantity to allow analysis in line with local legislation (9.8).

The standard does not require a certificate of analysis for each batch, but the release decision must be recorded along with the person who takes it. Many contract manufacturing customers also ask for that certificate.

Read it in context: Production and quality control, in the ISO 22716 Academy

Structure

Fields the template should include

Product, format and batch number
Review of the manufacturing and packaging records
Batch deviations and their closure
Test results against the acceptance criteria
Microbiological results, where applicable
Retained sample: quantity, location and date until which it is kept
Decision: released, rejected, held
Date and signature of the authorised person

Example

Example: release of the packed cream batch

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Batch	Moisturising cream CH-30 · 50 ml · batch 26-0418-A · 7,792 units
Record review	Manufacturing 26-0418 and packaging complete, no open deviations
Physico-chemical	pH 5.6 · viscosity 18,200 mPa·s · appearance and odour conforming
Microbiology	Total count below 10 cfu/g · pathogens absent · result dated 24 April
Net weight	Mean 50.8 g · no unit below the minimum in the sample
Retained sample	6 jars in the sample library, shelf M-4, until April 2030
Decision	Released · 24 April 2026 · quality manager

At the audit

Mistakes auditors commonly flag

Batches dispatched before the microbiological result is available.
Release signed by production or by the same person who manufactured the batch.
No retained sample, or one not in its final packaging.
Release on the test results alone, without reviewing the batch record.
Open deviations on a batch already released.

In Kimobox

How this record is kept in Kimobox

1Control results are linked to the batch before release.
2The release decision for each batch is recorded before distribution.
3The batch's nonconformities sit in the same record as its release decision.
4Traceability of the released batch, through to the customers who receive it, is one click away.

Frequently asked questions

What people ask us before getting started

Who can release a batch?

Authorised quality staff. ISO 22716 says so explicitly and, while it does not require a specific qualification, the authorisation must be defined in writing and kept separate from production responsibility.

How long is the retained sample kept?

The standard says "an appropriate time". It usually covers at least the shelf life of the product, and it is worth keeping it for as long as a complaint about that batch might be received.

What if the batch was made by a contract manufacturer?

Each party must be clear about who releases under the contract (chapter 12). The responsible person for the product under the Regulation must be able to show that the batch was manufactured and released in line with good manufacturing practice.

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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