Quality and Regulatory

 

In order to meet the Regulatory and Quality needs of PathoQuest’s biopharmaceutical customers, the company has implemented a quality program designed to address quality requirements as defined in detail within Chapter 6 (Quality Control) of the European Good Manufacturing Practice for Medicinal Products for Human and the Veterinary Use (E.U. CGMP) and in Current Good Manufacturing Practices 21 CFR Parts 210 and 211 (U.S. CGMP). Next-Generation Sequencing (NGS) is now referenced in newer guidelines, European Pharmacopeia (published January 2018). In line with the above, PathoQuest provides Next-Generation Sequencing (NGS) testing solutions which can be utilized for batch documentation in line with both E.U. and U.S. Marketing Authorization requirements.

In addition to the above and in order to meet both customer demands and regulatory requirements, PathoQuest is currently completing the Good Laboratory Practices (GLP) certification process using an overall quality management approach which aligns with ISO 9001:2015. The principles of GLP the company follows are based on Directive 2004/9/EC which is intended to ensure and promote the safety, consistency, high quality, and reliability of chemicals which are used in the process of non-clinical and laboratory testing conducted for non-clinical health and environmental safety studies.