SmithBio applies a rigorous quality program throughout the design, engineering, manufacturing and supply of its products and services.
Our cross-disciplinary Quality Management System adheres to various standards and regulations:
ISO9001:2015
SmithBio is certified for ISO 9001:2015 which guarantees that it’s quality management system
a) demonstrates its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) is aiming to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
SmithBio’s compliance to the ISO9001:2015 standard contributes to the sustainable development goals (SDGs) set by the UN in 2015, as part of an ambitious 15-year plan to address some of the most pressing issues faced by the world. Economic, environmental and societal dimensions are all directly addressed by these ISO standards.
https://www.un.org/sustainabledevelopment/
ASME BPE
Equipment manufactured by SmithBio have been created in adherence to the relevant ASME BPE standard, "Bioprocessing Equipment". This standard provides the requirements applicable for the design of equipment used in the bioprocessing, pharmaceutical, and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements.
ASME BPE is the leading standard on how to design and build equipment and systems used in the production of biopharmaceuticals, and incorporates current best-practices for enhancing product purity and safety. Companies that rigorously apply the ASME BPE standards can often achieve production efficiencies, lower development and manufacturing costs, and increase quality and safety, while complying with regulations. www.asme.org/certification-accreditation/bioprocessing-equipment-certification
cGMP
SmithBio designs and manufactures automated bioprocessing systems for the biopharmaceutical Industry that follow the industry guidance for cGMP manufacturing. These systems have been successfully validated and are being used every day in the cGMP production of regulatory approved biopharmaceutical products.
GAMP®5
SmithBio’s automation engineering complies with GAMP®5, the industry guidance for computerized systems, for good automation manufacturing practice. These guidelines to provide a framework for the risk-based approach to computer system validation where a system is evaluated and assigned to a predefined category based on its intended use and complexity. Categorizing the system helps guide the writing of system documentation, including specifications and test scripts and everything in between.
The GAMP®5 approach can be summed up by the V-model diagram.
The V-model verification process side-by-side verifies the specifications produced for a system to the testing performed. The types of specifications associated with a system are tied to its degree of complexity. The aim of conducting verifications is to demonstrate that the system functions as intended by using the requirements and specifications as an objective standard to which the system is tested.
The risk-based approach and strategies defined in GAMP®5 are in line with the application of the European EMA and US FDA regulations governing computer system validation, Annex 11 and 21 CFR Part 11, respectively.
ANSI/ISA88
ISA88 provides standards and recommended practices that are appropriate for the design and specification of batch control systems as used in the process control industries. Application of the ISA88 structure at the control level of SmithBio’s bioprocessing systems forms the basis for reliable and traceable process monitoring and communication with the Manufacturing Execution System (MES).
EHS
SmithBio complies with the relevant Environmental-Health and Safety (EHS) standard which refers to the series of laws, industry related regulations, and workplace procedures designed to protect the wellbeing of workers and to protect the public.
It is our promise and moral obligation to our workers and customers that we will treat them with care and respect. It also aligns with our commitment to staying at the cutting edge of our industry and doing better work for our customers.