QUALITY ASSURANCE & QUALITY CONTROL

QUALITY ASSURANCE & QUALITY CONTROL

If there is one emphasis to which Brawn Laboratories attach the utmost importance it is quality of product manufactured. Our operations are driven by best-in-class technology and processes, abiding by all stringent regulatory approvals. Our commitment to implementing a robust quality management system is based on our determination to sustain a culture of operational excellence, meeting and exceeding the expectations of patients, customers and regulators. Brawn Laboratories considers that the product will prevail in the market only when it complies with all internationally accepted good practices and standards of quality, purity, efficacy and safety. With the help of competent and qualified technical team, the organization is dedicated always to deliver quality products.

A well-established Quality Control laboratory with experienced hands and sophisticated equipments provides a control over the quality of input materials and products manufactured there by ensuring its quality throughout assigned shelf life. The alliance to regulatory standards assures patient safety and the data maintained for each product manufactured and tested is of highest accuracy and integrity.

To maintain QMS plant has laid down clear and well defined specifications ,procedures and systems in place for compliance with the requirements of the Current Good Manufacturing Practices (cGMP), WHO, and EU GMP in order to ensure that our operating procedures meet the stringent standards of all regulators.

Quality Assurance ensures that the latest updates in GMP are being translated into guidelines, standard operating procedures and protocols.

Quality Assurance team ensures that these guidelines are implemented to deliver quality products time to time. In addition, the plants are audited by QA Department with a view of ensuring GMP compliance. The establishment’s commitment to regulatory excellence supports the objective of providing safe and efficacious pharmaceutical products to the customers worldwide.

 

Quality Control

Brawn’s Quality Control (QC) team ensures the manufacturing of high quality products by control step by step review. Ensure the quality accuracy of each product manufactured by testing using state-of-the-art instrumentation and Very experiences and highly qualified team of professionals. To carry out all the necessary tests, our QC Laboratory has been equipped with a number of sophisticated Instruments – UPLC, HPLC with PDA & RI Detector, GC with headspace, Dissolution Tester, FTIR, Osmometer, Viscometer, Walking Type Stability Chamber, among others. A separate state-of-the-art laboratory is also in located next to the QC area to conduct microbiology testing.

Brawn has unmatchable standards and manufacture best quality products, satisfying parameters for all multi-nationals & big pharmaceuticals houses of the country and successfully qualifying International and National Audits. We ensure that the Analysis, Stability Studies and final inspection is done as per Current Good Manufacturing Practices (cGMP), GLP, WHO, and EU GMP in order to ensure that our operating procedures meet the stringent standards of all regulators. Brawn has received approvals from various Ministries of Health and major international regulatory agencies. Brawn employs the best of industry’s technical staff in its QC, QA, ‘Production & Product Development Department. Their continuous proactive efforts on the present and future needs of market are dedicated to meeting the customer requirements through consistent development of Technology, Quality, Drug Supplying Systems, Packaging and more. It is towards this end that the company believes in “Total Quality Management”.

Resources and Infrastructure

  • Advanced, latest technology and sophisticated instruments.
  • Knowledgeable and experienced staff to support and focus on key points.
  • Compliance all quality policies and procedures
  • Experienced and dedicated staff
  • Quality Monitoring by quality assurance and self-inspection team
  • Data controlling through networking server.