The services provided by CS Analytical are built on a foundation that adheres to a strict Current Good Manufacturing Practice (cGMP) quality system that is regulated by the FDA (Food and Drug Administration). These regulations and guidelines are outlined in the Code of Federal Regulations (CFR) Title 21 Part 210 “Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs” and Part 211 “Current Good Manufacturing Practice for Finished Pharmaceuticals.” These regulations set minimum requirements for the methods, facilities, and controls used in manufacturing, processing, testing, and packing of a drug product and the container and packaging component used to store and deliver them.
Under the direction of Quality Director Sandra Cincotta, the CS Analytical system is completely electronic and adheres to all 21 CFR Part 11 directives. The custom designed and built, multi-faceted system includes an Electronic Quality Management System (EQMS), an Electronic Laboratory Notebook (ELN) that enables secure digital data retention, and a Client Relationship Management (CRM) system all layered into and controlled by a Laboratory Information Management System (LIMS) that provides secure integrated connections for all workflows. This fully validated, secured, and continually backed-up system improves data integrity, limits opportunities for human error, and provides an audit trail of all functions and tasks performed with a digital date and time stamp.
The system enables a smooth and seamless approval and inspection process for client requested audits by offering a “virtual audit” feature that saves clients time and travel expenses. To request more information on the quality program or to schedule an in-person or virtual audit please contact Quality Director Sandra Cincotta: Sandra.cincotta@csanalytical.com
cGMP Certification Statement
CS Analytical is an FDA registered analytical testing laboratory; FEI # 3017927136. Work performed for submission to the FDA is done in compliance with cGMP guidelines (21 CFR Parts 210 & 211) as applicable to a contract analytical testing laboratory.
GOOD MANUFACTURING PRACTICES
CS Analytical has implemented current Good Manufacturing Practices (cGMPs) as stated in the code of Federal Regulations. These regulations apply to the facility or controls to be used for the “Manufacture, Processing, Packing or Holding of Drugs;” Although our facility does not perform these functions and are therefore not subject to these practices, we do operate within the following sections of the regulations: 21 CFR Subpart 11; 21 CFR Subpart 210; 21 CFR Subpart 211; 21 CFR Subpart 58; 21 CFR Subpart 820.
DEBARMENT CERTIFICATION
CS Analytical has not been debarred by the FDA nor is currently involved in any debarment proceeding with the FDA. Determined by a signed and dated certification statement, no person employed by the laboratory has currently or in the past five years been convicted of any crime described in Sections 306 (a) or (b) of the Generic Drug Enforcement Act of 1992. It is written per our internal quality system that CS Analytical has not, and will not, use the services of any person debarred under Section 306 of the Generic Drug Enforcement Act of 1992.