Guide
ISO 22716 — in brief
ISO 22716 is the international standard providing guidelines on good manufacturing practice (GMP) for cosmetic products. It covers production, control, storage and shipment — everything that affects the quality and safety of the product before it reaches the consumer.
The current version is ISO 22716:2007. In the European Union, Regulation (EC) No 1223/2009 requires cosmetics to be manufactured in accordance with good manufacturing practice, and manufacturing in line with the harmonised standard EN ISO 22716 is presumed to meet this requirement.
Who is ISO 22716 for
The standard is for everyone who manufactures, fills or packs cosmetic products:
- Manufacturers of cosmetics and personal care products
- Contract filling and packing companies
- Manufacturers of perfumes and fragrance products
- Manufacturers of natural and professional cosmetics
- Warehouses for cosmetic products
- Brands that outsource their production
What ISO 22716 requires
The standard sets requirements for personnel and training, premises and equipment, raw materials and packaging materials, production and packaging, the finished product, the quality control laboratory and the handling of out-of-specification products. Behind every part of the product there are GMP measures: for the contents — approved suppliers, quarantine until testing, the formula and instructions, and microbiological cleanliness; for filling — cleaned equipment, quantity checks, in-process control and records for every batch; for the label — the right label on the right product, a printed batch code and a check at every product changeover; for packaging materials — inspection on receipt, storage separate from raw materials and traceability of each delivery.
The standard also covers waste, subcontracting, deviations, complaints and product recalls, change control, internal audits and documentation — so that every batch can be traced back to the raw materials, the equipment and the people. The finished batch waits in quarantine until testing shows that it meets the specification.
The benefits
GMP is a condition for placing cosmetics on the EU market, and ISO 22716 certification is the clearest evidence of it — for the responsible person, retail chains, distributors and the control authorities.
In production, the system reduces errors: fewer deviations and complaints, faster investigation of a problem, and controlled changes to formulations and packaging. It is also the basis for the declaration of compliance with good manufacturing practice in the product information file (PIF), which the responsible person keeps for every product on the market for 10 years after the last batch has been placed on the market.
How implementation works
- Analysis of the current situationAn inspection of the premises, processes and documents against ISO 22716.
- Premises and flowsZones, hygiene, cleaning, equipment maintenance and pest control.
- Documents and recordsSpecifications, instructions, batch records, and procedures for deviations and recalls.
- Quality controlTesting, batch release and retained samples.
- Training and internal auditWe train your staff in GMP and check the system in operation.
- Certification auditWe prepare your site for the audit by an independent certification body.
What you get
- An ISO 22716 manual and procedures
- Specifications for raw materials and products
- Batch records and traceability
- A batch release procedure
- Procedures for deviations, complaints and recalls
- A cleaning and hygiene plan
- Staff trained in GMP
- Preparation for the certification audit