Quality Systems

MILESTONE

  • 1995 – Microfine incorporated as a partnership firm
  • 1996 – Commissioned a dedicated facility for APIs
  • 2006 – Commissioned India's largest cGMP contract micronizing facility
  • 2007 – Rechristened as Microfine Pharma (P) Ltd.
  • 2007 – Successfully FDA (Gujarat State) Inspected

We will strive to continuously improve our processes & services to customers by meticulously adhering to laid down SOPs and following cGMP standards.

QUALITY CONTROL & ASSURANCE

Microfine continually seeks to improve its Total Quality Management System for its micronization services.

We follow current Indian regulations, which meets the requirement of current Good Manufacturing Practice (cGMP) and quality controls recommended by “Schedule M” of the Drug & Cosmetics Act 1940, India.

Our Quality Assurance oversees every facet of the business that could impact product quality.  The facility and all operations are managed and documented under a Quality Assurance plan, which is maintained according to current cGMPs and requires that:

  • Micronization process are validated
  • Cleaning procedures are validated
  • Equipment and air handling systems are qualified
  • All process operations are fully documented (SOP, BMR etc.), updated and reviewed periodically
  • Internal and external audits are performed to ensure the highest quality standards
  • Qualified FDA approved personnel
  • Required testing 
  • Regular monitoring of process air quality
  • Particle size analysis by laser diffraction method
  • Particle size analytical method development
  • Document management (SOPs, BMR, etc.)
  • Analytical Data
  • cGMP Training
  • 100% Cleaning Verification