Cosmetic companies, regardless of the complexity and size, can implement ISO 22716. In addition, the ISO 22716 certification integrates well with BRC Consumer Products and ISO 9001.
EU cosmetics GMP requirements are included in the EU Cosmetics Regulation. The regulation created requirements to make sure customers and those involved in the cosmetics sector, whether European and non-European, are safe.

The legal requirements specify that all cosmetic products circulating in the European Union must be created in accordance with the ISO 22716 Good Manufacturing Practices. It covers essential processes like manufacturing, testing, labeling, packaging, distribution, and documentation.

Cosmetic companies can prove compliance either by an ISO 22716 certification or a declaration showing that the products are produced according to ISO 22716.

ISO 22716 has arranged the following specific requirements and principles:

• Personnel

ISO 22716 states that staff should have suitable training to manufacture, control, and store products that comply with quality standards.

It encompasses some characteristics and parameters, including an organizational chart, number of employees, key responsibilities of the management and staff, training and workshop, personal hygiene and health of staff, visitors, and untrained personnel.

• Equipment

Equipment should be relevant and useful for the intended purpose. All pieces of equipment must be cleaned, sanitized, and maintained. ISO 22716 requires a cosmetics company’s equipment to be designed, installed, calibrated, and have adequate back-up systems.

Moreover, use and access to equipment should be provided to authorized personnel only.

• Raw materials and packaging

ISO 22716 obliges that purchased materials, both raw and for packaging materials, should fulfill defined acceptance criteria significant to the quality of end products. It covers physical, microbiological, and chemical aspects. Likewise, the quality of water used in production must be controlled.

Proper criteria and measures must be set up for purchasing, receipt, status, release, storage, and re-evaluation of raw materials. Cosmetic companies should also provide accessible product information.

• Premises and Locations

Premises should be designed, constructed, located, and utilized to assure the protection of the product, as well as efficient cleaning, sanitation, and maintenance. This aims to minimize the risk of a mix-up of raw materials, packaging units, and products.

• Production

ISO 22716 obliges cosmetic companies to take measures in every stage of manufacturing processes and packaging operations to manufacture an end product that fulfills the identified characteristics.

Cosmetic companies should be able to ensure the availability of relevant documents, perform start-up checks, assigned batch numbers, and re-stock raw materials. They must identify in-process operations, in-process controls, and product storage during the manufacturing and packaging stages.

• Subcontracting

Subcontracting means obtaining a product or service that adheres with the requirements of the defined contract giver. A written contract of the agreement must be set, confirmed, and controlled by the contractor and subcontractor.

• Finished products

ISO 22716 compels cosmetic companies to make sure that the end products fulfill the defined acceptance criteria before distributing the products on the market. Likewise, finished products must be controlled in compliance with the set test methods.

Companies should handle storage, shipment, recalls, and returns in a way that maintains the quality of end products.

• Quality control laboratory

The quality control laboratory should apply the principles established by ISO 22716 for personnel, equipment, premises, subcontracting, and documentation.

The quality control laboratory must execute sampling, testing, and analysis to ensure relevant and necessary controls. This provides a safeguard that materials are dispensed for use and finished products are released for distribution, only if their quality meets the established acceptance criteria.

• Deviations

Deviations must be determined by collecting sufficient data and taking corrective measures. Another thing for cosmetic companies to remember is to identify the treatment of product that is out of specification.

• Waste Management

ISO 22716 requires cosmetic companies to dispose of wastes in a sanitary, orderly, and timely manner.

• Conducting and Controlling Changes

Authorized personnel should approve and conduct changes that could impact the finished product’s quality on the basis of adequate data.

• Handling complaints and recalls

ISO 22716 instructs that all complaints associated with the products need to be managed, investigated, reviewed, and followed-up on. Appropriate actions should be taken if there’s a recall, and corrective action must follow.

Meanwhile, both parties should concur on the system for handling complaints in the case of contracted operations.

• Performing an internal audit

Cosmetic companies are expected to monitor the implementation and status of the ISO 22716 Good Manufacturing Practices. Corrective actions should be recommended and planned if necessary.

• Proper and complete documentation

ISO 22716 states that documentation is a crucial part of Good Manufacturing Practices. Documentation aims to define GMP activities, secure evidence of processes, and prevent confusion and loss of information.

Cosmetic companies should create their own systems to establish, design, install, and maintain documentation, which must still depend on the type of products and organizational structure.