MANUFACTURING - QUALITY

At BSV, quality is not an act. It is a habit. For nearly five decades, our firm commitment to quality has helped us shoulder the responsibility of bringing life to life. Across functions and locations, our people have pledged to manufacture and market products that conform to the highest quality standards in accordance with the cGMP regulations laid down in all the functional areas.

Our quality policy ‘commitment to care for life’ , stems from our strong belief that quality is not just about conformance to specifications but is about being a way of life for every person or company involved in the products delivered by BSV

OUR QUALITY MANAGEMENT SYSTEM (QMS)

The QMS is designed to achieve operational excellence. Every product manufactured and distributed by BSV meets the highest quality standards including every specification and requirements of the manufacturing license.

The QMS is based on the EU guidelines and Drugs & Cosmetics Act, 1945 . Input controls, in-process testing, finished product analysis ,documentation, calibrated analytical instruments and employee training are seamlessly incorporated into this system. Our QMS binds all our functions to deliver on legal contractual and organisational requirements.

Every member of BSV’s leadership team takes complete ownership to implement and maintain the BSV QMS within their operational unit, site or country.

QUALITY ASSURANCE

The Quality Assurance team owns our QMS. This team ensures quality is built every operation carried out at BSV’s manufacturing facilities through

  • Quality Management System & Documentation
  • Qualification & Validation Section
  • In-process Quality Assurance (IPQA)
  • Analytical Quality Assurance
  • Training & Compliance
  • Developmental Quality Assurance (DQA)

QUALITY CONTROL

The Quality Control system is seamlessly integrated into every stage of the manufacturing process. Our aboratory is equipped with sophisticated instruments and& approved technical employees that ensure a highly efficient quality control process. The QC lab includes:

  • Instrumentation laboratory
  • Chemical laboratory (Wet Analysis)
  • Packaging material testing laboratory
  • Biological testing laboratory
  • Microbiological testing laboratory
  • Documentation section
  • Stability chambers, Incubators and Control sample storage area
  • Stability study and Method validation Section