Templates and records · ISO 22716

ISO 22716 templates and records

Nine cosmetic good manufacturing practice records, each with the ISO 22716 chapter that recommends it, what the European Cosmetics Regulation adds, its fields and a completed example.

In one sentence

ISO 22716 is a good manufacturing practice guideline that does not use the wording "shall be retained", but its documentation chapter asks for the history of each activity to be recorded; since Article 8 of Regulation (EC) 1223/2009 requires manufacture to follow good manufacturing practice and presumes compliance when this harmonised standard is followed, its records — receipt and release of raw materials, manufacturing and packaging batch records, release, out-of-specification results, deviations, complaints, recalls and changes — are in practice enforceable.

Content reviewed on 17 October 2026

Current edition: ISO 22716:2007 Confirmed at the 2022 systematic review
Legal obligation: Article 8 of Regulation (EC) 1223/2009 Manufacture must comply with good manufacturing practice
Product information file: 10 years From the date the last batch was placed on the market (Article 11(1))
Batch number: Mandatory on the label Article 19(1)(d) of the Regulation, the basis of traceability

Contents

ISO 22716 templates and records

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.

Frequently asked questions

What people ask us before getting started

Is ISO 22716 mandatory?

Certification is not. What is mandatory is manufacturing in line with good manufacturing practice (Article 8 of Regulation 1223/2009), and following ISO 22716, as a harmonised standard, gives a presumption of conformity. That is why it is the benchmark authorities inspect against and customers audit against.

Which records does the standard ask for?

Its chapter 17 asks for a documentation system that allows the history of activities to be reconstructed: procedures, instructions, specifications and records of receipt, manufacturing, packaging, control, release, deviations, complaints, recalls, changes and audits.

Are electronic records acceptable?

Yes. The standard expressly allows an electronic system for preparing and managing documents, provided versions and approvals are controlled and corrections leave a trace.

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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
Cosmetics and personal care products Agencia Española de Medicamentos y Productos Sanitarios (AEMPS, Spanish Agency of Medicines and Medical Devices) · Competent authority in Spain

ISO 22716 templates and records

In one sentence

ISO 22716 templates and records

Raw material receipt and release

Equipment cleaning and sanitisation

Manufacturing batch record

Packaging record

Finished product release

Out-of-specification result

Deviation record

Complaints and recalls

Change control

What people ask us before getting started

Is ISO 22716 mandatory?

Which records does the standard ask for?

Are electronic records acceptable?

Keep your ISO 22716 records without loose templates

Related pages

ISO 22716, without folders or surprises

ISO 22716 · Cosmetics (good practice)

Where each figure comes from