About Columbia Analytical
Columbia Analytical is an employee-owned professional analytical services laboratory which performs chemical and microbiological analyses for a diverse client base representing a wide variety of industries and services. Its Kelso, WA laboratory has a dedicated division to provide testing services to the pharmaceutical industry following the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practice (cGMP) regulations and other applicable guidelines and standards. The pharmaceutical testing division is registered with the FDA (registration number 3003800308) and obtains other certifications and registrations as required. Columbia Analytical also operates laboratories in California, Florida, New York, Arizona, and Texas.
The Quality Unit of Columbia Analytical's pharmaceutical division is composed of separate Quality Assurance (QA) and Quality Control (QC) functions. It is Columbia Analytical's policy that Quality Assurance in the pharmaceutical testing division ensures all analytical data generated and processed will be scientifically sound, legally defensible, of known and documented quality, and will accurately reflect the material being analyzed. This policy is realized by the Quality Control function which will adhere to established quality systems throughout the testing, verification, and reporting process. All analytical results generated by the Quality Unit of Columbia Analytical's pharmaceutical division will be calculated and reported in units consistent with project specifications to meet client requirements and to allow comparability of data. Columbia Analytical quality systems are documented as written standard operating procedures (SOPs) which include continuous training, means to assess system performance, and improve processes.
Columbia Analytical is fully committed to providing cGMP-compliant, efficient and cost-effective pharmaceutical testing services.