Quality Assurance

 

Commitment to Quality

KCAS’s commitment to our clients is to be a trusted partner by providing reliable and defendable data.  Data integrity is the core of everything we do.  We constantly strive to assure facilities, equipment, personnel, methods, practices, records and controls are in conformance with regulations.

 

KCAS operates its facilities in compliance with:

  • Applicable FDA Good Laboratory Practice (GLP) standards
  • 21 CFR Part 58
  • 21 CFR Part 11
  • 21 CFR 320.29
  • Organization for Economic Cooperation and Development (OECD) GLP Standards ENV/MC/CHEM (98)17
  • Applicable International Committee Harmonization (ICH) Good Clinical Practice (GCP) E6

 

KCAS follows several guidance documents and white papers including, but not limited to:

  • Guidance for Bioanalytical Method Validation, May 2018
  • Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry, December 2018
  • Guidance for the Immunogenicity Assessment for Therapeutic Protein Products, August 2014
  • Draft Guidance for the Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, April 2016
  • 2017 EMA Guideline on Immunogenicity assessment of Therapeutic Proteins
  • European Medicine Agency’s (EMA) Guideline on Bioanalytical Method Validation (when specified per protocol)

 

Commitment to Data integrity

In pursuit of KCAS’ Mission to provide reliable and defendable data, quality is one of our core values.   Our ability to provide review of procedures, training, facilities, methods, equipment, systems, data and reports in a timely manner is what sets our QAU apart.  KCAS Quality Assurance reports metrics to Management and coordinates review with Operations to ensure the timelines of our sponsors are met, or exceeded, and quality is not sacrificed.

 

Quality Team

We have a diverse team of experienced Quality Assurance auditors that specialize in Pharmaceutical, Biopharmaceutical, and Biomarker activities with an average of over 12 years of experience.  Our Quality team attends numerous conferences and workshops to ensure we are up-to-date with compliance and industry guidelines including Society of Quality Assurance Annual Meeting and Workshop on Recent Issues in Bioanalysis (WRIB).

 

Current Industry Trends

Our Quality team attends numerous conferences and workshops to ensure we are up-to-date with compliance and industry guidelines.

 

Licenses

  • Kansas Board of Pharmacy – Annual Laboratory Certificate 8-01101
  • DEA – Controlled Substances Registration Certificate RK0393190, for schedules 1, 2, 2N, 3, 3N, 4, 5
  • Kansas Department of Health and Environment Radioactive Materials License Number 26-B688-01
  • Department of Health and Human Services – Permit to Import and Transfer Etiological Agents or Vectors of Human Disease, Permit2013-01-097

 

Regulatory Inspection History

  • KCAS has had 16 FDA inspections in our company history
  • KCAS has not had any studies rejected by any regulatory authority

 

Links

Society of Quality Assurance https://www.sqa.org/

American Society for Quality https://asq.org/