Commitment to Quality
Quality is one of KCAS’ core values. Although the Quality Department is independent of Laboratory Operations, both areas work within a culture of Quality to achieve regulatory compliance, meet quality requirements and satisfy client expectations. The Quality metrics are reported to leadership regularly as part of the continuous improvement program. A Quality Policy and Quality Manual are maintained and updated each year to ensure best practice and adherence.
Quality is built into the KCAS DNA and is every employee’s responsibility.
KCAS operates its facilities in compliance with the following, as applicable:
- Food and Drug Administration (FDA) Good Laboratory Practice (GLP) 21 CFR Part 58
- FDA Electronic Records; Electronic Signatures 21 CFR Part 11
- Organization for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice ENV/MC/CHEM (98)17
- FDA Analytical methods for an in vivo bioavailability or bioequivalence study 21 CFR 320.29
KCAS follows the below guidance’s and guidelines, as applicable:
- FDA Guidance for Industry, M10 Bioanalytical Method Validation and Study Sample Analysis, November 2022
- FDA Guidance for Industry, Bioanalytical Method Validation, May 2018 (Biomarkers)
- FDA Guidance for Industry, Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019
- EMA ICH guideline M10 bioanalytical method validation and study sample analysis, July 2022.
- EMA Guideline for Good Clinical Practice (GCP) E6(R2), December 2016
Other regulatory guidelines may be followed on a protocol or contract-specific basis.
The Quality Team is led by Tracy Clark-Stovall, M.S., Sr. Director, Quality. With a background in chemistry which started on the laboratory bench and progressed into laboratory management, Tracy has a solid laboratory foundation. With a career that flourished in Quality Control, Quality Assurance and Quality Management Systems in leadership positions for over 25 years, with extensive experience in FDA-regulated environments, Tracy is well-positioned to lead a talented and diverse team of Quality professionals.
The team has varied experience including CRO, GLP, GCP and GMP backgrounds with exceptional focus in Quality Assurance. The team is cross-trained and calibrated to ensure that all regulated projects receive the same timely QA review to be able to meet client-required timelines.
In order to be well-informed of respective current and up-and-coming regulatory requirements, KCAS has various ways to acquire up-to-date regulatory information. These include, but are not limited to:
- Electronic receipt of regulatory notices, (example such as those from FDA)
- Participation in industry groups such as Society of Quality Assurance (SQA), Workshop on Recent Issues in Bioanalysis (WRIB), and AAPS PharmSci 360
- Attendance at industry conferences with related regulatory topics
- Webinar attendance of related regulatory requirements
- Kansas Board of Pharmacy – Annual Laboratory Certificate 8-117449
- DEA – Controlled Substances Registration Certificate RK0393190, for schedules 1, 2, 2N, 3, 3N, 4, 5
- Department of Health and Human Services – Various Permits to Import Infectious Biological Agents, Infectious Substances, and Vectors
- U.S. Fish & Wildlife Service Import/Export License 10529A
Regulatory Inspection History
- KCAS has had 17 FDA inspections in our company history.
- KCAS has not had any studies rejected by any regulatory authority.