BBInternational’s Quality Assurance
Quality at BBI
Complete commitment to quality is the foundation for BBInternational’s working practices. Comprehensive and fully accredited Quality Management Systems are implemented and maintained on all BBI sites. The management team see quality principles as a business enhancement as well as a requirement for regulatory compliance. It is upon this basis that BBI has been able to succeed in highly regulated markets and also ensures that we maintain excellent working relationships with our global customer base.
Quality Policy and Quality Objectives
The Quality Policy is communicated throughout the organisation and is continually reviewed in order to ensure it stays current to customer requirements and regulatory changes. Setting, monitoring and review of a wide range of Quality Objectives across all company functions ensure that our systems and procedures are working to maintain our exceptional levels of quality.
Quality Assurance – Gold
Meticulous processes and rigorous testing following fully documented protocols ensures that all of our products meet tight specifications. It is this focus on quality, coupled with our unique manufacturing process that has resulted in BBInternational colloids being recognised as the ‘gold standard’ within the lateral flow diagnostics industry.
Quality Assurance – Test Development and Manufacture
All of BBInternational’s development and manufacturing processes are performed within the framework of the ISO 9001 and ISO13485 based quality management system, and adhere to the requirements of FDA 21 CFR part 820 quality system requirements (cGMP). A tested design and development process is followed and a comprehensive design history file is produced for each project.
Involvement of operations expertise in all phases of BBI projects and a controlled transfer to production process gives assurance that established designs will meet quality requirements once in routine production. Risk management, validation and change control systems are applied to all products. Staff training is comprehensive and documented. Strict document and batch record controls ensure that a full history of each batch is documented and readily retrievable.
Meeting Regulatory Requirements
Amongst the large number of regulatory requirements both BBInternational and/ or BBI’s customers are required to comply with are:
- The United States Food and Drug Administration FDA regulatory requirements for in vitro diagnostic products for human use
- The In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC): CE Marking
- The Canadian Medical Device Regulations
- The Japanese PMDA requirements
- Chinese SFDA requirements
- The United States Department of Agriculture (USDA) requirements for Veterinary Biologics
- American Organization of Analytical Communities (AOAC)
- Applicable regulations for the sale and distribution of in vitro diagnostics in Australia Pacific region, the Middle East and Latin America.
The BBI quality system reflects this in terms of its structure. Our expertise in quality and regulatory requirements for in vitro diagnostic products also enables us to assist customers’ with regulatory planning and provide support for compliance issues including design control, risk management, regulatory submissions, labelling, change control, regulatory inspections and contracts.
Customer Audits
Our aim is to maintain the highest standards of quality as well as exceptional levels of service. We are confident that the procedures that we have in place allow us to exceed our customer's expectations. We are always receptive to customer requests to carry out audits in which we can demonstrate the flexibility of our quality framework.
In addition copies of our certificates can be downloaded from the links below.
Downloads
ISO13485 CMDCAS Dundee
ISO 9001/ ISO 13485 Dundee
ISO 9001 / ISO 13485 Cardiff
ISO 9001/ ISO 13485 Madison