Quality Control and Quality Assurance


Kemwell has created a culture of high quality and continuous improvement over the last 40 years.

Kemwell team has extensive audit handling experience and capabilities. The facilities are audited by reputed global multinational clients, European QPs, former USFDA inspectors and regulatory agencies. A USFDA Pre-Approval Inspection (PAI) for a BLA filing is expected in near future.

Multipronged Approach

Kemwell takes a multipronged approach to reinforce the Quality Systems:

  • Delivering the highest quality products and services on time has been a part of Kemwell’s culture and commitment.
  • Emphasis on creating a “Quality at Source” culture from the shop floor to the boardroom with our “Champions Initiative”
  • Creating transparent quality metrics and review systems
  • Building compliance teams and quality review teams to maintain high compliance levels and monitor for continuous improvement
  • Making employees aware, providing training and discussions of audit findings of public knowledge from global health authorities
Quality Assurance

Quality Control


Stability Studies


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    Kemwell Pharma