ISO 22716 is an international standard that specifies requirements and guidelines forGood Manufacturing Practices (GMP) in the cosmetics industry. This standard focuses not only on the overall quality of the product, but especially on safetyand hygiene aspects at all stages of the cosmetic product lifecycle, from receiving raw materials to shipping the finished product.
The standard is essential to meet the global regulatory requirements of many markets, such as the European Union and the United States, which require compliance with good manufacturing practices to ensure safe cosmetic products are offered to consumers. ISO 22716 aims to provide a practical framework for managing the human, technical and managerial factors that affect product quality and safety.
Key areas of application covered by the standard:
The standard covers all the elements needed to manage the quality of the manufacturing process. Its requirements include the following:
- Personnel: Ensure that employees are adequately trained in hygiene principles and correct procedures, and that their responsibilities are clearly defined.
- Buildings and equipment: Design facilities and buildings to ensure a logical flow that prevents cross-contamination, andensure that equipment is regularly calibrated and maintained.
- Raw materials and packaging: Define specifications, check the quality of incoming materials, and have a storage system that ensures their safety.
- Production processes: Documenting manufacturing procedures, controlling mixing, filling, and monitoring during the process to ensure consistency.
- Laboratory and quality: An effective quality control system, including sampling and necessary testing of raw materials and finished products.
- Deviation and Complaint Management: Provide a system to manage non-conforming products, handle customer complaints effectively, and have procedures in place to withdraw products from the market when necessary.
Development Experts’ methodology for GMPimplementation according to ISO 22716
We offer a customized guided path to help cosmetics manufacturers achieve ISO 22716 compliance, transforming GMP from a requirement to a competitive advantage:
1. Gap Analysis and Infrastructure Assessment
We assess your current buildings, equipment, and process flows against the requirements of the standard. We identify gaps related tocontamination controland material flow, and develop a detailed action plan to address any design or operational deficiencies that compromise product safety.
2. Documentation of Standard Operations Procedures (SOPs)
We support the facility in developing or updating all Standard Operating Procedures (SOPs) needed to cover every stage of the product lifecycle, from material receipt to storage and shipping. This documentation ensures that processes are replicated with the highest standards of hygiene and quality.
3. Team training and skills enhancement
We launch specialized training programs focused on hygiene awareness and GMP principles for all relevant employees, including production, warehousing and QA. The goal is to instill a culture of quality and safety that is the cornerstone of the standard.
4. Verification of laboratory controls and quality management
We verify that the quality control system implements effective testing procedures for materials, including stability and microbiological compatibility tests. We also develop mechanisms to document Batch Records and Retention Samples.
5. Internal Audit and Product File Preparation
We conduct comprehensive internal audits to ensure full readiness for certification. We also help organize and document the information needed to compile a Product Information File (PIF), a critical requirement to allow products to be sold in global markets.
The end result
By implementing ISO 22716, the organization not only ensures the safety of its cosmetic products for the consumer, but also gains international recognition that opens doors to global markets with stringent regulatory requirements. This minimizes the risk of product recalls, increases consumer confidence, and achieves operational excellence in one of the most competitive and sensitive industries. Want to learn more about specific building and equipment requirements?
