How to Build an ISO 22716 Cosmetics GMP System

Building an ISO 22716 cosmetics good manufacturing practice system starts with a working document management system, just as any ISO standard requires. Staff job descriptions must be clearly defined, competencies must be documented, staff must be properly trained and qualified in their subject area, and the top management of the company must be strong and engaged. Safe production is only possible in an organisation that meets those baseline conditions.

At each of the various production stages, core decisions such as release, quarantine, and product rejection must be assigned to named roles, and the personnel responsible for error control, supervision, audits, change control, and internal audit must all be defined and documented. These responsibilities must be communicated to staff across the organisation. As a quality standard requirement, the methods that staff use to communicate with second and third parties must be set out for every level of the workforce.

These items cover the ISO 22716 requirements on the organisational side. Separately, the requirements on operating equipment, instruments, and facilities must be accurately and practically defined. Production and material handling procedures and work instructions must all be documented. Another point that matters during an ISO 22716 build is defining the workflows for production deviations, user complaints, and mandatory product recalls. As with every quality system, continuous improvement is a core theme here too. Processes must be kept under control and improvements must be made at the times and places where they are needed.

The Facility Requirements

Beyond the documentation and the personnel, the standard is specific on the facility itself: the layout of the production area, the flow of materials from receiving through production to shipping, the cleanability of the surfaces, the zoning between areas of different risk, and the environmental controls over temperature, humidity, and air quality. The cleaning regime, the equipment calibration schedule, and the pest-control programme all form part of the operating evidence the auditors will look at on site.

Sistem Patent Kalite is a certification and consultancy firm that supports the build of ISO 22716 cosmetics GMP systems. For further information on what a build requires, or to engage us for the project, contact our experienced managers and staff.