Cerilliant is completely committed to quality at every level of the organization, and sustains a robust, comprehensive, modern quality system that incorporates quality by design, continuous improvement, and vigorous risk management. Cerilliant employees don’t consider this mandate of quality to be a burden but rather, approach it as a personal quest taken seriously by every member of the team. Throughout the company, at every level, Cerilliant employees are willing to do whatever is necessary to ensure that every job is done right.

Cerilliant management is also actively involved in quality improvement on a day-to-day basis. In addition to providing its dedicated staff with necessary resources, the management team encourages a collaborative, problem-solving culture that fuels innovation and accountability.

The company’s quality system is designed to meet or exceed the requirements of ISO 9001:2000, most of the requirements of ISO 17025, ISO 34, and the FDA’s current good manufacturing practice (CGMP) regulations, Parts 210 and 211 (interpreted for application to the production of reference standards). Cerilliant is certified to the ISO 9001:2000 standard by BSI.

The Cerilliant quality system incorporates the following elements:

• Full documentation of all quality policies and operating procedures and documentation of deviations.
• A comprehensive and rigorous continuous improvement process that involves every employee and every facet of the organization and is focused on addressing deficiencies and inefficiencies at the root level as well as implementing new knowledge into all processes.
• The practice of Quality by design in conjunction with the quality system is employed during product development, manufacturing and testing.
• Active participation of the management in the design, implementation and monitoring of the quality system.
• The use of design records and batch records which fully document production of raw materials, finished products, and provision of services, providing complete traceability of all materials and reagents used (to container, vendor lot, and test data), equipment utilized, staff performing each function, test specifications, test methods and data, necessary procedures, any relevant handling or heath and safety Information.
• Peer review of all completed design and batch records in addition to QA review.
• An independent quality control (QC) department which is charged with determining the suitability of incoming components, in-process materials, and finished products. QC is also responsible for developing analytical methods, determining appropriate test plans for each compound, stability testing, setting expiry dates, and investigating and documenting any non-conformance to established acceptance criteria and, if appropriate, recommending any remedial action.
• A quality assurance (QA) department, independent of production and QC, which is responsible for managing the quality system, review and approval of all quality documents, monitoring compliance with quality policies and procedures, internal and external auditing, tracking and trending of data, and determining the acceptability of each batch prior to release.
• A Corrective and Preventive Action system that focuses on investigating, understanding and correcting discrepancies and preventing their recurrence.
• Change control to prevent unintended consequences and implement continuous improvement.
• The use of cross functional teams for product design, identification of product and process improvement, and resolution of identified product or material failures.
• Full characterization of raw materials, whether procured or produced in-house, including, identity, purity, residual solvent, and water and inorganic content prior to release for use in Cerilliant products.
• Full testing of finished products for homogeneity, purity, and concentration.
• Setting of expiry dates and storage conditions based on scientific data including ongoing stability testing.
• Calibration, qualification, regular cleaning, and maintenance of equipment used in the manufacture and testing of products in accordance with established written procedures.
• Qualification of all analytical equipment used for testing of materials and products including an installation qualification and operational qualification prior to use, and an operational qualification on an annual basis thereafter.
• Fully documented testing methods.
• The use of duplicate testing methods when non-validated purity methods are employed to ensure the highest level of quality in analysis.
• A supplier qualification program which ensures that suppliers are routinely evaluated for quality of materials provided and contract laboratories are qualified and audited on a regular basis.
• Segregation of various operations to facilitate material flow and to prevent contamination or mix up.
• Material management programs which include segregation of quarantine, non-released materials, released materials, and finished products and monitoring of storage conditions for all products.
• Packaging and labeling controls documented in written procedures and in each batch record.
• Tracking and monitoring of customer feedback, including complaints.
• Archival and backup systems for all quality documents and raw data.
• Stringent hiring practices. All staff undergoes rigorous background checks and drug screens prior to employment as well as random drug screening during employment.
• A formal, job based, training program which ensures staff members are proficient in operational functions they are required to perform.
• Continuous training and professional development programs.