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ISO 22301:2012 ; Cosmetics GMP

Introduction to ISO 22716-2007-Cosmetics – Good Manufacturing Practice (GMP)

Consumers are becoming more and more concerned about the safety of the cosmetic products they are using. Fears of allergies and dermatitis caused by tainted or poisoned cosmetics have been ever-present in recent years. Certain ingredients used in cosmetics, such as fragrances and preservatives, can trigger an allergic reaction. Obviously, these ingredients play a pivotal role in the cosmetic products of our choice and correct dosing of these substances therefore is of key importance to avoid irritation of the skin through over-exposure. Examples of over-exposure to preservatives have frequently been observed in several historic cases, one example being beauty creams that contained mercury. Beauty creams occasionally were reported to contain excess amounts of mercury, with poisoned consumers exhibiting clear toxic neurological symptoms.

What is Cosmetic GMP- Good Manufacturing Practice:

Cosmetic GMP-ISO 22716 is an international standard for the cosmetics manufacturing industry.It describes the basic principles of applying GMP in a facility that produces finished cosmetic products and  offers organised and practical advice on the management of human, technical and administrative factors affecting product quality.

ISO 22716 covers manufacturing, storing, packaging, testing and transportation processes. It does not apply to research and development activities and the distribution of finished cosmetic products. Even though the standard focuses on product quality, it does not include the safety of the employees engaged in production or protection of the environment.

Why Cosmetic GMP-

  • Improves quality manufacturing management efficiency including continual improvement
  • guarantees quality and safe use for the consumer
  • positively influences key customer retention
  • maintains overall competitiveness

What benefits Cosmetic GMP- Good Manufacturing Practice it brings to Business?

  • Enables the organisation to manage the quality and safety requirements of its supply chain.
  • Controls hazards and risks associated with cosmetic products, ensuring continuous improvement.
  • Implemented easily in all sizes and levels of complexity, and compliance of legal requirements.
  • Ensures that the organisation meets legal compliances.

Whom Cosmetic GMP- Good Manufacturing Practice is applicable:

  • Cosmetic product manufacturers, distributors and importers / exporters.
  • Not applicable to research and development activities and distribution of finished products.

Our Consulting approach:

  • Gap Analysis:  Assessment of existing management system practices against the selected standard requirements.
  • Project Plan: Prepare a implementation project plan based on the time lines looking for; 
  • Orientation Training:  Top/Senior Management orientation on selected standard requirements and implementation action plans preparation;
  • Developing different levels of documentation ( Tier 1-3/4): Identification of processes required for the products produced and services provided; External and internal issues affecting the business, interested parties needs and expectations, Framing draft quality policy, organizational objectives, role, responsibility and authority, various risks affecting and opportunities arises, functional and system procedures, different implementation formats and checklists;       
  • System Implementation: Implementation of the selected management system as per the developed documentation;
  • Company-wide Training: Training on detailed clause wise requirements and relating them to their  departments, 5-S implementation, and Internal audit.
  • Internal Audits: Periodic assessment of system implementation and corrective actions.
  • Pre assessment:  Initial audit by Certifying agency, and, implementation of corrective actions.
  • Final Assessment: Certification audit by the Certifying agency and recommendation for certification
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