BBI Enzymes Quality Assurance Statement
BBI Enzymes, with the support of all its shareholders and the commitment of its staff, has embarked on a campaign of improvement and growth in all facets, viz., quality, service, research, development, management & operational structure, production facilities, cost, sales and marketing. Our vision is to become the world’s leading supplier of natural enzymes by consistently providing a high quality product and service, alongside the development of long term partnerships with customers and suppliers.
It is recognized that an active commitment by all employees to quality is essential in order to succeed in the highly regulated markets. This also ensures that we maintain excellent working relationships with our global customer base.
The company is happy to share its technical experience and knowhow in support of customer activities, and has excellent troubleshooting and product development capabilities in response to customer requirements.
It is the declared intent of BBI Enzymes to pursue a strategic policy of continuous improvement guided by the principles of Lean and the development of a total Quality culture.
United Kingdom
The BBI Enzymes UK facility based in Blaenavon has been supplying high quality enzymes to the worldwide diagnostics market for over 35 years and has well-established supply partnerships with many of the world’s leading diagnostic companies.
To enable this, the company maintains a well-established ISO 9001:2008 compliant Quality Management System, with continual improvement being achieved through the setting of quality objectives.
Our highly experienced Manufacturing, Quality Control and Process Development teams interact closely to ensure that a consistently high quality of product is offered to the customer.
ISO 9001:2008 Certificate
South Africa
BBI Enzymes SA was established in Cape Town in 1955 for the purpose of commercialising groundbreaking results of biological research, carried out at the time by the local university on serum and vaccines, these being the first types of products supplied by the company.
A market need for enzymes of plant, animal and marine origin led to a change in focus. With the passing of time, BBI Enzymes SA rapidly became a bulk supplier of natural enzymes to the clinical diagnostic, pharmaceutical, healthcare, cosmetic and food and beverage industry.
Compliance includes both national and international quality standards and regulations.
ISO 9001:2008 certification
Company procedures have been constructed to comply with company objectives and the ISO 9001:2008 requirements. Our ISO 9001:2008 certificate is issued by SGS International Accredited Auditing Company.
ISO 9001:2008 Certificate
TSE Certification of Suitability
Issued by the (EC) European Directorate for the Quality of Medicines and Health for biologicals derived from animal origin for use in human and veterinary medicinal products.
EDQM TSE - Hyaluronidase
EDQM TSE - Deoxyribonuclease
EDQM TSE - Mucopolysaccharidase
EDQM TSE - Proteases
EDQM TSE - Ribonuclease
www.edqm.eu
South African (SA) Department of Agriculture, Forestry and Fisheries ZA certification
The ZA certificate reflects compliance with both Regulation (EC) 1774/2002 for the import of animal by-products in to the EU and approval by the S.A. Department of Agriculture, Forestry and Fisheries in terms of section 22 of the Meat Safety Act 2000 (Act No. 40 of 2000) for the import and processing of animal and plant material. Compliance is audited by the State Veterinary Office on an annual basis.
ZA certificate
www.nda.agric.za/vetweb/
GMP Certification for API
BBI Enzymes SA has a GMP certificate demonstrating compliance with nine (9) of the principles of the WHO guideline for Good Manufacturing Practices for active pharmaceutical ingredients.
GMP Certificate
Pharmaceuticals and Medical Devices Agency (PDMA) Registration
www.pmda.go.jp/english/index.html