Quality Assurance

Quality Assurance is not a department, it is the foundation of all we do.

Commitment to quality is at the forefront of everything we do. Our robust quality assurance systems range from non-GMP pre-clinical work through GMP production manufacturing. 

  • GMP manufacturing is conducted using QA issued batch records, with equipment that is validated, calibrated, and maintained to ensure materials are acceptable for use in GMP applications
  • Quality control laboratory utilizes state of the art validated instruments that are calibrated and maintained through a preventative maintenance program
  • Quality assurance ensures all raw materials, in-process and finished products are controlled, tested with validated methods and released utilizing approved material specifications and QA release procedures
  • SOP system that ensures compliance with all Quality Assurance Systems including OOS and Exception procedures that ensure thorough root cause investigations are conducted, including CAPA and continuous improvements to systems and processes
  • Extensive training program to ensure all analysts are knowledgeable regarding safety requirements, technical expertise, and cGMPs

Crititech CGMP-Compliant Quality Systems

  • Training Program (GMP, Safety, and Technical)
  • Standard Operating Procedures (SOPs) with Training Curriculums
  • Calibration and Preventive Maintenance Program (Facility, Equipment, Instruments)
  • Out of Specification (OOS) Procedures
  • Validation Program (Facility, Equipment, Instruments)
  • Deviation and Investigation Procedures
  • Change Control Process for all Validated Systems and Procedures
  • Corrective and Preventive Actions (CAPA) Tracking and Effectiveness
  • Internal Audit Program – Monthly Audits with CAPA
  • Cleaning Verification / Validation
  • Vendor / Supplier Audit Program
  • Facility Cleaning Program
  • Quality Assurance Metrics and KPI’s