Key requirements of ISO 22716 – what must a cosmetics manufacturer comply with?

Implementing ISO 22716 involves much more than simply drawing up a set of procedures and instructions. It involves establishing a management system that covers every stage of a cosmetic product’s life cycle – from the receipt of raw materials to the dispatch of the finished product to the customer. Below, we discuss the areas of key practical importance that are scrutinised most closely during certification audits.

Raw materials, production and quality control

Management of raw materials and packaging materials. ISO 22716 requires that each batch of raw material undergo an acceptance procedure before being released for production, comprising verification of the supplier’s documentation, a visual inspection and – depending on the specification – laboratory testing. Each raw material must have an approved specification, and suppliers must be formally qualified. Raw materials that do not comply with the specification must be clearly labelled, isolated and subjected to a documented procedure.

Manufacturing process and batch records. Each batch of a cosmetic product must be manufactured in accordance with an approved formulation and documented manufacturing instructions. The standard requires batch records to be maintained for each batch, containing information on the raw materials used, process parameters, the results of in-process controls and the signatures of the responsible persons. Batch records are the primary evidence that a given batch of product has been manufactured in accordance with the requirements – and are among the first documents to be verified during an audit.

Quality control of the finished product. ISO 22716 requires that each batch of finished product undergo a documented quality control process before being released for sale, comprising at least a verification of compliance with the approved product specification. The scope of testing depends on the nature of the product – it may include microbiological, physicochemical and organoleptic tests. The standard requires the appointment of a person or department responsible for batch release – the decision to authorise the product for sale must be documented and unambiguous.

Infrastructure, hygiene and staff

What requirements must a production facility meet? The facility must be designed and maintained in such a way as to prevent product contamination. The standard sets out requirements concerning the flow of materials and personnel (separation of clean and dirty zones), ventilation and air conditioning, lighting, and the surfaces of walls, floors and ceilings – which must be easy to clean and non-absorbent. Regular inspection of the premises and documentation of the results are mandatory. The requirements described above stem from the principles of Good Manufacturing Practice (GMP), which form the basis of the ISO 22716 standard. We have discussed their significance and application in more detail in the article ‘ISO 22716 (Cosmetics GMP) – what is it and why do cosmetics manufacturers need to be familiar with it?’.

What does the standard say about staff hygiene? ISO 22716 requires the development of documented personal hygiene policies, covering requirements for protective clothing, hand washing and disinfection procedures, a ban on eating and drinking in production areas, and procedures to follow in the event of illness or injury. Hygiene training must be carried out regularly and documented.

How does the standard address staff competence? All staff must be suitably qualified for the tasks they perform. The training programme must cover GMP requirements, job-specific procedures and hygiene rules. Training outcomes must be documented and regularly reviewed.

Documentation, complaints and product recalls

• Documentation system – all key processes must be described in approved procedures, and their implementation documented in records. Documents must be up to date, approved and available at the points of use. The system must include a change control procedure – any modification to a formulation, process or specification requires formal approval prior to implementation.
• Handling of complaints and adverse events – the facility must have procedures in place for receiving, recording and analysing consumer complaints. Each complaint must be assessed for its impact on product safety. Regulation (EC) No 1223/2009 also imposes an obligation to report serious undesirable effects (SUEs) to the relevant national authorities.
• Product recall – documented recall procedures are required to enable the rapid identification and recovery of all batches of the product currently on the market. These procedures must be regularly tested through simulations – this is one of the elements verified during certification audits.

Compliance with all the requirements of ISO 22716 involves not only preparing documentation, but also ensuring that production processes and quality control are properly organised, and that the entire facility is subject to systematic oversight. If you are planning to implement the standard or prepare for certification, find out what a professional ISO 22716 implementation entails and how we can support cosmetics manufacturers.