Responsabilités and training.
Clarify roles, develop the necessary skills and maintain practices appropriate to the tasks performed.
ISO 22716 · Bonnes pratiques de fabrication
Organize production, control, storage, documentation and shipping according to an international framework of good manufacturing practices adapted to cosmetic products.
ISO 22716 fournit des lignes directrices relatives aux bonnes pratiques de fabrication pour la production, le contrôle, le stockage et l’expédition des produits cosmétiques. Elle vise les aspects qualité du produit et l’organisation des opérations concernées.
Qu’est-ce que ISO 22716 ?
The standard provides a framework for organizing cosmetic manufacturing activities in a coherent manner: personnel, premises, equipment, materials, production, control, storage, documentation, variance management and associated operations.
It does not constitute a product regulation alone and should not be presented as an absolute guarantee of compliance with all obligations applicable in all markets.
Who's she talking to?
Manufacturers, shapers, quality managers, production, laboratory, packaging, compliance or direction: the relevance of the repository depends on the activities actually covered and the scope chosen.
Personnel · local · equipment
A GMP approach is not limited to procedures: it links skills, responsibilities, accommodation, flow, maintenance and contamination prevention with actual operations.
Clarify roles, develop the necessary skills and maintain practices appropriate to the tasks performed.
Concevoir l’organisation des espaces afin de soutenir la maîtrise des opérations et de limiter les risques de confusion ou contamination.
Use appropriate equipment, maintained and managed in a manner consistent with the activities.
Implement hygiene practices and preventive measures relevant to the manufacturing context.
Production · control · documentation
The robustness of GMPs is based on defined operations, appropriate controls and documentation that can demonstrate what has been done, by whom, under what conditions and with what results.
Storage · shipping · subcontracting
The quality of operations must remain consistent after manufacture: identification, storage conditions, flow, dispatch and control of activities entrusted to external parties must be organised according to risks and responsibilities.
Organize areas, conditions, status and movements in order to preserve the identification and control of products and components.
Maintain identification and appropriate conditions until exit of the operational area concerned.
Define the requirements, responsibilities, exchange of information and means of control appropriate to the relevant outsourced activities.
Certification/evaluation
The following route is voluntaryly general. ISO publishes the standard but does not certify the organisations. The exact scheme proposed by Moody, its scope, the decision modalities and the follow-up must be validated before final publication.
Present the activity, need and reference.
Specify the activities, sites, products and operations involved.
Structure and operate relevant GMP practices.
Review the organization and practices against the applicable framework.
Analyze and process required deviations or items.
According to the applicable scheme and the rules actually adopted.
According to the validated modalities for the device concerned.
Expected benefits
Les résultats dépendent du contexte et de la qualité de mise en œuvre. La norme peut néanmoins aider à rendre l’organisation plus cohérente, plus traçable et plus lisible.
Current edition
The ISO indicates that the first edition of the MTM_ENTITY_0__ was published in November 2007 and was reviewed and confirmed in 2022. It therefore remains the current published edition.
Champ officiel
The standard covers the quality aspects of good cosmetic manufacturing practices and does not cover, as a whole, the safety of staff or the protection of the environment.
Échanger with Moody ↗ISO 22716
Perimeter, covered activities, differences with ISO 9001 and evaluation modalities: key points need to be clarified before starting.
FAQ ISO 22716
ISO 22716 provides guidance on good manufacturing practices for the production, control, storage and shipping of cosmetic products.
Yes. The official ISO page indicates that the 2007 edition was reviewed and confirmed in 2022; it remains the current published edition.
The official ISO summary covers the production, control, storage and dispatch of cosmetic products, and specifies that the research and development and distribution of finished products are not covered by these guidelines.
ISO 9001 is a generic quality management system standard. ISO 22716 is specifically focused on good manufacturing practice guidelines for cosmetic products.
Not as a whole. The ISO states that these aspects are not covered by all the guidelines ISO 22716 and may fall under other responsibilities, regulations or management systems.
The exact course depends on the applicable scheme. At Moody, the scope, steps, decision, follow-up and accreditation status must be validated before being published as official terms and conditions.
The deadline depends in particular on the scope, the activities, the level of maturity of the practices, the number of sites and the really applicable assessment scheme. No generic deadline is guaranteed here.
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your project ISO 22716
Present your activities, sites, production, control and storage organization and the level of maturity of your practices. Moody will be able to fit your need and specify the device applicable after validation of the perimeter.
Expertise Moody
ISO 22716 s’inscrit dans une démarche structurée de certification. Moody aide les organisations à comprendre les exigences applicables, préparer les preuves utiles, clarifier le déroulement de l’audit et relier le projet aux priorités opérationnelles sans ajouter de complexité inutile.
Commencez par clarifier le périmètre, les sites, les activités et les processus concernés. Identifiez les équipes impliquées, la documentation disponible et l’objectif attendu. Cette préparation facilite le premier échange et permet de concentrer la suite de la démarche sur les éléments réellement utiles.
Après le premier échange, l’équipe Moody peut examiner le contexte, expliquer le parcours de certification applicable et préciser les informations nécessaires à la planification. L’objectif est d’établir une séquence claire d’actions tout en gardant les responsabilités, les délais et les preuves faciles à comprendre.
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