The T-QMS operation follows guidelines for GLP, cGMP, Bio-Safety Compliance, ISBER and NCI Best Bio-repository Guidelines. KamTek has established Quality improvement Program (QIP) to provide a framework for progressive improvement in all of our technical, management and communication processes to maintain the current Good manufacturing practices (cGMP) and Good Laboratory Practices (GLP) standards. The Standard Operating Procedures (SOPs) along with associated Forms and Record Keeping Systems are established and maintained according to KTI Quality Manual.

FACILITY MANAGEMENT SERVICES & PRACTICES

to ensure optimal performance of the instrumentation and the infra-structure;

A KEY FACTOR FOR THE SECURITY & INTEGRITY OF BIOSPECIMENS & EXPERIMENTAL DATA

T-QMS & PRACTICES FOR BIO-REPOSITORY FACILITY

Regular periodic quality checks of the performance of Bio-repository facility infra-structures executed by a cohesive team of highly qualified KTI staff and qualified staff of validated business partners are:

1. Management of Facility Security System, QC checks, review & save data

2. Management of Rees Centron Freezer Temperature Monitoring System, constant periodic performance checks on all its components, review & save reports.

3. QC of Backup Power Generator, periodic performance check of its components on regular basis and more closely during commercial power outage including checks on fuel supply

4. Ensure uninterrupted supply of LN2 by monitoring its level on daily basis

5. Manual LN2 fill on top of Automatic fill of LN2 freezers

6. Validation of QA/QC records

7. Respond to activated freezer alarms within thirty minutes after notification

8. Handling Equipment breakdowns and repairs: including

• Corrective & Prevention Action (CAPA) report

• An Emergency Cryo-storage Equipment Safety Intervention (ECESI) Report

• Temporary Transfer of Reagents:

• Event Report

• Equipment Repair

9. Provide access to the repository area to clients on a pre-scheduled basis

10. Get annual preventative maintenance inspections (PMI), calibration of freezer temperature probes and laboratory equipment such as incubators, water baths, centrifuges, Pipettors and certification of biosafety hoods

11. Validate Critical Equipment

Schedule of Facility Management operations is established to ensure that the entire system continues to be 100% operational and consequently integrity of bio-samples is maintained. The recorded QA/QC data can be used to accurately forecast and more importantly historically document that the facility and its security system was operational for the entire contractual period. An equipment file for each component of the system is kept at the repository to maintain all service records for routine and/or emergency repairs, periodic inspections, and all observations, discrepancies and corrective actions.

SOPs have also been established and followed for responding to each i type of alarm system, and for emergency preparedness. Such an operation was put in to practice during Hurricane Sandy and all the biological products stayed safe without any compromise. -.

TQM SYSTEM AND PRACTICES FOR SAMPLE MANAGEMENT

Established Formalized QA/QC policies

• To preserve integrity of bio-specimens in our custody

• To process and test them in most optimal manner and

• To track them through various storage conditions, locations, processing and testing procedures

QA/QC procedures involve:

• Adherence to SOPs for all laboratory and bio-repository operations

• Equipment monitoring, maintenance and repair

• Record Keeping

• Training of staff for adherence of best repository practices, GLP, cGMP and safety practices.

Data security measures are taken for:

• Physical, Operating System, Network and General database Security,

• Restriction of Data Access with accounts and privilege set,

• installing back up and Anti-virus procedures

Audits and inspections are used to provide an assessment of strengths of the safety program as well as determine areas, which need improvement.

Established Safety, Health, Pest control and Waste Management Programs:

In full compliance with

• federal and state Occupational Safety and Health Administration laws,

• federal and state EPA laws,

• NI H/CDC Guidelines for Bio-safety in Microbiological and Biomedical Laboratories, and

• USDA regulations for the Importation of Cell Lines and Vectors.