ISO22716 Cosmetics GMP standard accreditation
BUBENDORF, Switzerland (May 22nd, 2019) — Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced today that its Manchester site successfully passed the accreditation for the ISO22716 Cosmetics GMP standard.
CARBOGEN AMCIS Ltd (Manchester) successfully passed two stages of audit in December 2018 and in March 2019 by a third-party certification body conducted by Lloyd's Register Quality Assurance Limited. The audit sessions were to assess the compliance of the Quality Management System of CARBOGEN AMCIS Ltd against ISO 22716:2007.
The new accreditation solidifies the Manchester site capabilities for cosmetic ingredient development and production, allowing for production, control, storage and shipment of active ingredients for skin cream cosmetic products.
“CARBOGEN AMCIS Ltd has been developing and manufacturing cosmetic ingredients for over 20 years. We have a dozen cosmetic ingredients in development and/or production,” said Mark Griffiths, CEO, Dishman Group. “CARBOGEN AMCIS Ltd has a portfolio of cosmetic ingredients and the decision to implement the standard was to provide a Quality Management System to support the current and future cosmetic ingredients portfolio. Moreover, it will provide the basis for all of the products manufactured at the Manchester site and is not restricted to only cosmetic ingredients.”
“Our team was fully committed to successfully achieving this accreditation. The work involved the co-ordination of all departments across the site to implement the requirements of the standard,” said Ian Burley, Director ESQ. “We took a number of steps to meet the accreditation standard’s requirements, such as: gap analysis audits from external companies including CARBOGEN AMCIS AG Switzerland (Mother Company), training for key personnel and workshops. In addition, we have arranged specific external training for staff to ensure internal audits are conducted correctly and in a consistent manner,” added Ian Burley.
“This certification process is integrated in our commitment for continuous quality made by CARBOGEN AMCIS group in order to provide full customer satisfaction and safety by ensuring the quality of the production, storage and shipment of products,” said Robert Rhodes, Manchester Site Director/Director Technical Operations. “In order to maintain the standard, we will be audited every 6 months to ensure compliance is met.”
Manchester’s facility is fully integrated into the in-house supply chain for complex APIs. With over 30 years of experience, the site employs approximately 80 people. Site information at-a-glance:
- Process research and custom synthesis of pharmaceutical intermediates, cosmetic ingredients and fine chemicals
- 30 L to 4500 L reactors, cryogenic up to 3000 L
- Production of early-phase APIs and large-scale intermediates
- 50% of technical staff hold Ph.D. qualifications
- > 100 projects per annum
- In-house technologies to support different types of chemistry
- Analytical laboratories and safety lab
CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Limited, Ahmedabad, India.
Dishman Carbogen Amcis Limited (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.