Contract Research Organization
Liveon Biolabs Pvt. Ltd. is strengthened with In-House Quality Assurance Unit (QAU) lead by a head supported with QAU personnel.
The QAU is a defined system, including personnel, which is independent of study conduct and is designed to assure Test Facility Management (TFM) of compliance with the principles of Good Laboratory Practice (GLP) to deliver quality results by following proper methodologies and procedures.
Our In-House Quality Assurance Unit thoroughly monitors following aspects of study:
- Conducts regular inspections which are study based, facility based and process based accordingly as and when required and in a timely interval.
- Maintains and documents copies of all approved study plans and Standard Operating Procedures (SOPs) which are in use in the test facility.
- Keeps track and maintains up-to-date copy of the master schedule.
- Reviews all SOPs before issue in order to ensure the clarity and compliance with GLP principles.
- Verifies the documents in the test facility before sending to archives facility.
- Reviews the study plans at draft stage to ensure the GLP compliance and guideline requirements.
- Conducts joint inspection with TFM once in six months to ensure the test facility is functioning in compliance with GLP.
- Lends his support in preparing Quality Assurance Statement which specifies types of inspection and their dates, including the phase(s) of the study inspected, and the dates on which the inspection results were reported to the TFM and the study director.