QUALITY CONTROL

Proton follows good manufacturing, laboratory and documentation practices that ensure consistent high quality results. Our state-of-the-art analytical facilities monitor and maintain strict quality of our products, processes and services while meeting national and international quality standards.

Proton’’s quality chain covers three key functional areas:

  • Quality Control
  • Quality Assurance
  • Regulatory Affairs

Quality Control (QC) is responsible for all analyses undertaken at Proton.

  • Raw material analysis
  • Material Inprocess Analysis
  • Accelerated Stability Studies
  • Real Time Studies
  • Validation of products
  • Development and documentation of analytical data

We constantly strive to improve our quality checks. To achieve the quality goal, we have continuous improvement systems in place. During manufacturing, strict emphasis is laid on Processes, Quality and Testing to ensure the product performance and reliability.

A dedicated team of professionals ensure that all the raw materials are tested as per the well established quality standards. Testing and acceptance norms at every stage of the manufacturing process are clearly well defined in our quality management system. The QA department ensures the compliance of manufacturing processes to the quality management system established by the company.

All the instruments and equipments used by QA department are periodically calibrated at external independent testing laboratories.

Quality Assurance (QA)

Quality Assurance Is responsible for implementation of quality systems and release of all manufactured products.

Develops and ensures coordination of all systems throughout the organization. It is also responsible for all audits including regulatory (National and International),GMP and GLP.

Regulatory Affairs:

Regulatory Affairs ensures compliance with national and international regulatory requirements.