SIST EN ISO 22716:2008

Overview

EN ISO 22716:2007 (ISO 22716:2007, corrected 2008-05-15) - "Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices" - provides practical, product-focused guidance for the cosmetic industry. The standard addresses the production, control, storage and shipment of cosmetic products, concentrating on product quality assurance throughout the manufacturing flow. Note: ISO 22716 covers quality aspects only; it does not address worker safety or environmental protection, and it is not applicable to research & development activities or to the distribution of finished products.

Key Topics and Requirements

ISO 22716 organizes GMP guidance around the product flow (receipt → production → shipment) and adds a clear principle for each major section. Key technical topics include:

• Personnel - training, responsibilities and hygiene relevant to product quality
• Premises and equipment - design, maintenance and cleaning to prevent contamination
• Raw materials and packaging materials - receipt, identification and storage controls
• Production and in‑process controls - manufacturing operations, batch control and traceability
• Finished products - labelling, release criteria and storage prior to shipment
• Quality control laboratory - sampling, testing and acceptance criteria
• Handling non‑conforming product - out‑of‑specification (OOS) results, reprocessing and returns
• Supporting processes - waste management, subcontracting, deviations, complaints, recalls, change control and internal audit
• Documentation and records - essential for traceability, batch numbering and audit readiness

Documentation is emphasized as an integral part of GMP: procedures, batch records, specifications and audit records are required to demonstrate compliance.

Practical Applications

ISO 22716 is used to establish or improve a cosmetic quality management system focused on manufacturing practices and product quality. Typical applications:

• Building site-level GMP procedures and batch documentation
• Defining training programs for production and QC personnel
• Preparing for internal and external audits or regulatory inspections
• Implementing batch traceability, change control and recall processes
• Managing subcontracted manufacturing or packaging activities

Who Should Use This Standard

• Cosmetic manufacturers and contract manufacturers
• Quality assurance and regulatory affairs professionals in cosmetics
• Production and QC managers, auditors and consultants
• Suppliers of raw materials and primary packaging seeking alignment with cosmetic GMP expectations

Related Standards

ISO 22716 was developed by ISO/TC 217 (Cosmetics) and is adopted as a CEN standard (EN ISO 22716). It complements broader quality management frameworks and national cosmetic regulations by providing sector‑specific GMP guidance.

Keywords: ISO 22716, EN ISO 22716:2007, cosmetics GMP, cosmetic good manufacturing practices, cosmetic quality assurance.