GLP Testing Services



12.07.2010

A Commitment to Ensure Compliance

The entire IST organization operates with a full quality system compliant with GLP guidelines and relevant international safety regulatory requirements. IST’s “state-of-the-art” facilities for immune monitoring, cell mediated immunity, particle testing, automation, and particle characterization, meet cGLP standards, and are in the process of obtaining CLIA certification.

Quality CheckKey to meeting cGLP standards is IST’s error-free performance standard, based on prevention and a “right-first-time” attitude. This is achieved in numerous ways. First, IST has made a commitment to ensure compliance with all current regulatory requirements. This is accomplished by monitoring changes to regulatory requirements that might impact the various aspects of our business. Routine internal audits of IST facilities are conducted to ensure that we are operating in compliance with regulatory guidelines and our quality program. The IST Quality Management team also manages an extensive instrument qualification, calibration and maintenance program.

“At IST, we take our commitment to quality very seriously because it is central to our work and the value we deliver to our customers. From the management team to every employee and partner, a common and essential shared value is a commitment to providing the best quality management system and training to maintain the highest quality products and services.” Ileana Munoz Antoni, VP, Quality

At IST quality is a must and a pre-requisite for success. Ours is a business of precision and accuracy, reproducibility and specificity, timeliness and trust. These are our real products and services. These are what set IST apart from other contract research and particle characterization companies. These are what our clients require, demand and expect … and IST delivers.

“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” William A. Foster

IST quite literally “wrote the book” on cell analysis testing. That is, they were asked to write a chapter of a book titled Validation of Cell-Based Assays in the GLP Setting: A Practical Guide, by authors/editors Uma Prabhakar and Marian Kelley (Publisher John Wiley and Sons, 2008, ISBN 0470028769, 9780470028766). Chapter 8 of this book is titled: “Intracellular cytokine detection by flow cytometry”, and it was authored by IST scientists Julie G. Wilkinson, Carlos A. Aparicio, and Wade E. Bolton.

Highlights of the IST GLP Program

• Inspection-ready always

• Full Quality Management SystemQuality at the Center

• Regular Internal and External Auditing

• CAPA Program

• Revision-Controlled Quality Documentation System

• Record Retention Program

• Electronic Data Backup/Archive Systems

• Disaster Response and Business Continuity Plan

• Vendor qualification program

• Company QA UnitQuality Checklist

• Off-Site Record Archives, Secure and Controlled

• On-Site Record Storage, Secure and Controlled

• Environmental Control & Monitoring

• Equipment Calibration/Certification

• Back up equipment and instruments

• Generator electrical power back up system

• Instrument and equipment acceptance testing

• Instrument IQ/OQ/PQ

• Instrument Point-of-Use QC/QA Excellent Checklist

• Instrument Performance Monitoring

• 24/7 Security Controlled Access to Facilities

• Employee training

• Operator Qualifications

• EHS Programs for Fed/State/Local regulations

• Chemical and reagent identification and traceability

• Sample chain of custody from receipt to discard/return

• Data traceability to original sample

• Privacy of sample and patient identifiers

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