ISO 22716-2007 (2008) rus PDF

Full title and description

ISO 22716:2007 — Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices. (Русский заголовок: «Косметика. Надлежащая производственная практика (GMP). Руководящие указания по надлежащей производственной практике»).

Abstract

Guidance standard giving practical recommendations for the production, control, storage and shipment of cosmetic products, focusing on quality-related aspects and documentation needed to implement Good Manufacturing Practice (GMP). The guidelines do not cover R&D activities, nor do they replace legal requirements for personnel safety or environmental protection.

General information

• Status: Published; International Standard (confirmed through periodic systematic review).
• Publication date: First published November 2007; corrected (English) version May 2008.
• Publisher: International Organization for Standardization (ISO); Russian-language edition prepared under GOST R (Russian national adoption/publication).
• ICS / categories: 71.100.70 (Cosmetics).
• Edition / version: Edition 1 — ISO 22716:2007 (with 2008 English corrigendum); internationally confirmed in subsequent 5‑year reviews.
• Number of pages: 21 (typical ISO PDF pagination).

Scope

Provides guidance for manufacturers and supply‑chain organisations on implementing GMP for cosmetic products: covers organisation and quality systems, personnel, premises and equipment, raw materials and packaging control, production operations, laboratory controls, storage and shipment, documentation and traceability. It is intended to help ensure product quality; it is not a safety regulation for workplace health or environmental protection and does not apply to R&D or distribution activities.

Key topics and requirements

• Quality management system and responsibility of management (GMP system organization).
• Personnel: training, hygiene and competence requirements.
• Premises and equipment: design, maintenance and cleaning to prevent contamination.
• Raw materials and packaging: specifications, receipt, storage and release control.
• Production and in‑process controls: process instructions, cross‑contamination prevention, batch traceability.
• Quality control laboratory operations: sampling, testing, equipment calibration and records.
• Documentation and record keeping: batch records, procedures, specifications and retention.
• Handling of deviations, complaints, recalls and corrective actions.
• Storage, distribution and transportation: conditions, identification and traceability.
• Continual improvement and internal audits.

Typical use and users

Used by cosmetic manufacturers (including contract manufacturers), quality and regulatory departments, auditors and certification bodies, suppliers of raw materials and packaging, and national regulators seeking a harmonised GMP approach. It supports conformity with regional regulations (for example, it has been used as a basis for EU and other regulatory approaches to cosmetic GMP).

Related standards

Closely related to national/adopted versions (e.g., national GOST R / Russian translations), EN/European adoption practices, and other ISO management standards used alongside GMP such as ISO 9001 (quality management), and sectoral guidance like EU Regulation 1223/2009 on cosmetic products. It is produced under the work of ISO/TC 217 (Cosmetics).

Keywords

ISO 22716; cosmetics; GMP; good manufacturing practice; quality assurance; production control; traceability; hygiene; GOST R; Russian edition.

FAQ

Q: What is this standard?

A: ISO 22716:2007 is an international guidance standard that defines Good Manufacturing Practices (GMP) for cosmetic products to help ensure consistent product quality.

Q: What does it cover?

A: It covers production, control, storage and shipment of cosmetics, plus the supporting documentation, personnel and facility requirements needed to implement GMP. It does not cover R&D activities or replace workplace safety/environmental regulations.

Q: Who typically uses it?

A: Cosmetic manufacturers (including contract manufacturers), quality/regulatory teams, auditors, suppliers and regulators use it as a benchmark for GMP implementation.

Q: Is it current or superseded?

A: The published edition is ISO 22716:2007 (with a corrected English version in May 2008). ISO records show the 2007 edition has been subject to systematic reviews and was confirmed in subsequent reviews (most recently confirmed during ISO's review cycle); it remains the current ISO document. Users should check national adoption status and any national amendments.

Q: Is it part of a series?

A: It is produced under ISO/TC 217 (Cosmetics) and is commonly used alongside ISO management standards (e.g., ISO 9001) and regional cosmetic regulations; while not a numbered "series" like ISO 9000, it belongs to the family of cosmetics standards and sector guidance.

Q: What are the key keywords?

A: Cosmetics, GMP, good manufacturing practice, quality assurance, production control, traceability, hygiene, GOST R (Russian adoption).