Free template · Manufacturing

Cosmetic GMP self-assessment following ISO 22716

A first look at good manufacturing practice in your own plant or at your contract manufacturer. The questions follow the topics of ISO 22716, which Article 8 of the EU Cosmetics Regulation refers to. They replace neither an audit nor a full self-assessment.

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Cosmetic GMP self-assessment following ISO 22716

VYVA
Site / contract manufacturer:
Area:
Carried out by:
Date:
Personnelmetpartlyopen
Tasks and responsibilities are defined in writing
Staff are trained for their tasks, and the training is documented
Hygiene rules and protective clothing are defined and followed
Premises and equipmentmetpartlyopen
Premises are laid out to prevent mix-ups and contamination
Cleaning of premises and equipment is planned and documented
Equipment is maintained and measuring devices calibrated, with records
Raw materials and packaging materialsmetpartlyopen
Incoming goods are checked and labelled (quarantine, released, rejected)
Specifications and test methods for raw and packaging materials exist
Storage conditions are defined and expired stock is identified
Productionmetpartlyopen
Every product has a written manufacturing instruction in its current version
Every batch is recorded with weights, parameters and deviations
Raw-material batches used can be traced to each finished batch
Finished product and quality controlmetpartlyopen
Every batch is released by an authorised person before dispatch
Tests follow defined methods with acceptance criteria
Retention samples are kept
Deviations, complaints, recallsmetpartlyopen
Deviations and out-of-specification products are recorded and assessed
There is a procedure for complaints and recalls
Changes to processes, raw materials or equipment are assessed before implementation
Subcontracting, audit and documentationmetpartlyopen
Tasks are agreed in contracts with contract manufacturers and test labs
Internal audits take place and actions are followed up
Documents are controlled: current version, approval, archiving
The responsible person holds a current GMP statement

Actions, owner and due date

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Terms of use: the tools and templates are free, non-binding working aids. Statements on legislation refer to Regulation (EC) No 1223/2009 as of October 2026 and are simplified; they are not legal or regulatory advice. Results are drafts and replace neither review by qualified people nor the safety assessment under Article 10. Responsibility for the product, its labelling and the product information file stays with the responsible person. We are liable for damage arising from use only in cases of intent and gross negligence; liability for injury to life, body or health and under product liability law remains unaffected.

Formula, INCI list and documents from one source?

In VYVA, batch weights, cost and the INCI list come from the approved formula version and stay current with every change.

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