ISO 22716:2007

Lakshy Management Consultant Pvt. Ltd. is one of the largest and leading ISO 22716 consultants in India. We are transnational ISO certification consultants with clients in India, USA, UK, Saudi Arabia, Kuwait, Middle East, Europe, Africa, Australia, Singapore, Hong Kong, UAE, Qatar, Oman, Russia etc. We provide quick, result oriented and easy to implement consultation and training for ISO 22716 certification.

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ISO 22716 quality management system implementation with the consultants and experts of Lakshy Management Consultant Pvt. Ltd. not only assures 100% successful ISO 22716 certification but also improves process performance and business operations.

Consultants of our organization assist your company in your quality management initiative through ISO 22716 certification to get your company ISO 22716 certified quickly with the ease of implementation and in the most cost effective manner. We make sure that ISO 22716 standard implementation does not just become a documentation activity but also a way of life for the organization that lays a foundation for Total Quality Management and quality conscious organizational culture.

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Biggest benefit an organization gets out of ISO 22716 QMS is improvement in business process control through process standardization. No matter what benefits you are looking for from ISO 22716 certification, we will make sure that your organization benefits from ISO 22716 implementation and certification.

ISO 22716 is an international standard used in various countries, and it has links to many other cosmetic regulations around the world. ISO 22716 gives guidance for the production, control, storage and shipment of cosmetic products. It deals with all aspects of the supply chain of cosmetic products.

History of GMP:

• 1938 - GMP are enforced by the FDA as a result of the 1938 Food, Drug and Cosmetic Act
• 1950 - GMP are established for the pharmaceutical industry in US and Europe
• 1976- Establishment of the European Cosmetic Regulation 76/768 EWG
• 1992- Establishment of FDA Cosmetic GMP Guidelines under the Federal Food, Drug and Cosmetic Act emphasizing the prohibition of bringing into commerce cosmetics those are adulterated or misbranded.
• 1994- Publication of European (Colipa) Guidelines on Cosmetic GMP
• 1995- Publication of GMP Guidelines by the Council of Europe
• 2002- ISO WG 6 is activated to develop a GMP guidelines standard for cosmetics
• 2003- ASEAN Guidelines for Cosmetic GMP published in compliance with the provisions of the ASEAN Cosmetic Directive
• 2007- Introduction of ISO 22716 on the GMP for Cosmetic Products
• 2009- Regulation EC 1223/2009 on cosmetic product consumer safety passes the European parliament
• 2011- Reference to ISO 22716:2007 as a harmonized standard for GMP in the European Union (publication 2011/C 123/04)
• 2012- Publication of the Cosmetic Safety Amendments Act to modernize federal oversight of cosmetics and personal care products (HR 4395)
• 2013- Draft guidance published by US FDA Cosmetic GMP guidelines and inspection checklist, considering ISO 22716:2007

Elements of ISO 22716:

• The cosmetics quality management system and organization
• Premises and equipment
• Product realization and materials management
• deviations, complaints and recalls
• Continuous improvement

Requirements and implementation:

The Quality unit of an organization needs to be independent in its decision making process from the Manufacturing/Operations unit. This can be established through organizational charts:
Both the Quality unit and the Manufacturing/Operations units need to report to the senior management of the site. The organizational chart needs to be a unique (version controlled) document and be signed and dated by senior management. Individual job descriptions of the Head of Quality and the Head of Manufacturing/Operations need to be published and also signed by their respective managers. The job description of the Head of Quality needs to contain clear references to the responsibilities and authority of quality issues: to release product; move product to a different quality status (e.g.,quarantine, release, rejected);deviation control and investigation; change control; and internal audit among other responsibilities.

• Integrates the typical requirements for product and process quality.
• Allows easy implementation in organizations of all sizes and levels of complexity
• Forms an internationally accepted basis for quality and safety compliance in the cosmetic products supply chain
• Fosters legal compliance as adopted by regulators around the world
• Controls and reduces cosmetic products hazards and promotes continuous improvement throughout the supply chain
• Good Manufacturing Practices requirements with other quality guidance, for example as laid down in the prerequisites for ISO 9001

With a team of highly qualified consultants and trainers having vast industrial experience, Lakshy Management Consultant Pvt. Ltd. assists organizations across the world to implement and achieve ISO 22716 certification. Our consultation approach is highly professional, time bound and effective resulting in ease of implementation and adds value to the business processes of the client’s organization.

We offer ISO 22716 training, implementation, consultation, gap analysis, documentation, internal audits, pre-assessment audits, certification audit through best of the certification bodies and post certification enhancement / maintenance services to enable your organization to get the best out of ISO 22716 quality management system. Our services are globally accepted, authoritative and benchmarked in the field of ISO 22716 QMS:

Contact us at info@lakshy.com to get your organization ISO 22716 certified.