Quality and
Certifications

Quality and Certifications

At GVK BIO, safety, quality and compliance are given utmost priority, and is a philosophy driven by the leadership team. The quality system is integrated across the organization to ensure abidance to global standards and regulatory standards.

The standards set by bodies such as USFDA, PMDA, MHRA, TGA and TPD to name a few, form the backbone of our quality systems. In addition, we consult ICH, ISPE, PIC/S and Indian drug standards guidelines to ensure harmonization of law in all aspects.

Our manufacturing division has passed several regulatory inspections from USFDA, EDQM, PMDA, WHO and MFDS among others to showcase compliance with applicable standards. Numerous global clients’ inspections for discovery, development and manufacturing operations have shown GVK BIO to be a compliant organization with prime focus on continual improvement.

Quality Policy

To actualize the vision of being a global leader, we ensure that our services adhere to the highest global quality standards and even, setting new benchmarks. This is achieved by:

  • Consistently meeting or exceeding client’s quality requirements
  • On schedule to meet client’s need
  • Continuously improving on systems and processes
  • Continuous learning through training to serve clients better
  • Recognizing that quality is not just another goal, but the core value for organizational growth

Quality Management System (QMS)

A few for example:

  • Site master file
  • Master validation plan
  • SOPs/Guidelines for all activities
  • Data integrity
  • Vendor qualification
  • Product release
  • Incoming materials testing and release
  • Out of Specification (OOS), Out of Trend (OOT), change control and deviation management
  • Complaint redressal
  • Periodic internal audits
  • cGMP training and periodic re-training

Global Accreditation