Consultants
Cosmetics GMP Consultant
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"Keep it Simple. Keep it Real."
--- The GMP Consultant
"Everything you need!"
--- Amelia Manlutac, Cedars-Sinai Medical Center
The Certify Consulting Group offers practical GMP consulting services for cosmetics manufacturers within the United States. We employ lean implementation methodologies to ensure a quick and effective certification at a price that you can afford.
Our experienced consultants have helped hundreds of cosmetics companies achieve their GMP certification within a matter of months and with a 100% success rate.
What is ISO 22716?
ISO 22716 is an international GMP standard for cosmetics manufacturers.
The Benefits of Hiring a GMP Consultant
The ISO 22716 GMP standard has over 200 requirements. Unfortunately for the young cosmetics company, most of those requirements are left intentionally vague in order to allow for adaptation to the most current best practices. The GMP consultant can be a tremendous asset in designing the perfect compliance solution that not only meets the FDA's requirements, but also meets your internal requirements and culture. There is no need to spin your wheels wondering whether your solution is adequate, and there is no need to reinvent the wheel when your consultant can improvise a solution from vast experience.
"A full suite of services to ensure you have a smooth A to Z certification experience."
Custom GMP Documentation
Your ISO 22716 consultant drafts all of your GMP documentation. This includes SOPs, forms, checklists, SSOPs, registers, and any other document you will need to pass the certification audit. Also, your consultant works to ensure that your procedures align perfectly with your actual practices.
Gap Assessment and Action Plan
Your path to compliance is made possible through a gap assessment and a detailed action plan. This action plan is at the heart of the entire implementation project. Your consultant creates this plan after performing the gap assessment.
GMP Implementation
The implementation of your GMP program is a major project. For this reason, Certify Consulting has developed an online project management system to help manage your implementation from A to Z. Your consultant will ensure that all steps are completed and all requirements are met before your certification audit.
Custom Software Solutions
Certify Consulting has developed its own turn-key GMP software solution. Alternatively, we can work with your in-house solution to ensure that your GMP compliance is sustainable. The main priority is ensuring that you can maintain long-term compliance with the 200+ ISO 22716 requirements.
GMP Training
Certify Consulting has developed its own practical, hands-on GMP training. Training is available live as well as through our Learning Management System.
HACCP Plan
HACCP means Hazards Analysis and Critical Control Points. A HACCP Plan helps you to manage the risks that threaten product quality and safety. Your ISO 22716 consultant writes your first HACCP Plan after identifying the hazards inherent in your productin processes.
Other included ISO 22716 subjects are: packaging material; storage, and distribution; shipping and receiving; supply chain management; product safety and stability; process control; quality control; finished product sampling and testing; internal audits; legal requirements and regulatory oversight; and senior management commitment.
Jared Clark JD MBA PMP
Jared began his career as a legal and compliance officer dealing in FDA and SEC matters. When company operations took a bad turn, Jared was also given the additional role and title of Operations Manager and asked to bring operations back into alignment with stakeholder expectations. This experience gave birth to Jared's passion to work within companies at the ground level to help them achieve FDA compliance.
As a cosmetics GMP consultant, Jared has helped over 100 companies to achieve GMP certification. Jared also has professional certifications in project management and lean implementation in order to help his clients achieve certification more quickly and easily.
"Jared was always ready to help!"
-- Yoedvin Vasquez, President of Axcex
"Jared was able to help us meet our deadline of two short months. The price point of his services were very competitive. We are extremely pleased with his professionalism and expertise."
-- Brian Cunningham, CFO of Pronto Solutions
ISO 22716 is an internationally-recognized standard that outlines Good Manufacturing Practices, or GMPs, for the cosmetics industry. The current standard is ISO 22716:2007.
Good Manufacturing Practices are required by the FDA for the following industries: Cosmetics, Food, Dietary Supplements, Medical Devices, and more.
The ISO 22716 standard mirrors the FDA requirements and ensures product quality. ISO 9001 is another ISO standard that addresses product quality. ISO 9001 is the most popular ISO management system standard in the world. However, ISO 22716 is more specific to, and therefore more appropriate for, cosmetics manufacturers. Compliance with ISO 22716 also reflects compliance with FDA requirements.
Manufacturers of finished cosmetic products who certify to ISO 22716 enjoy many benefits, including:
- Increased sales
- Enhanced image
- Improved operations
- Regulatory compliance
ISO 22716 Resources
Unfortunately, the ISO 22716 standard is a copyrighted document, so a verbatim ISO 22716 checklist cannot be provided. However, the standard can be purchased direclty from ISO.org or from ANSI, and there are many articles that can be found on our Blog.
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