Quality Management | Quality Control | Quality Assurance | Regulatory Affairs

Global Channel Partners | Awards & Recognitions
Home Contact Us Sitemap
Vitamin D3 and Penicillin G Acylase
Quality Management
 


Fermenta Biotech Limited follows good manufacturing practices that ensure consistent high quality results. Our analytical facilities monitor and maintain strict quality of our products, processes and services, consistently meeting Ph.Eur, USP, IP and other national and international quality standards.

Fermenta’s quality management covers three key functional areas:Vitamin D3 USFDA FAMI-QS

  • Quality Control
  • Quality Assurance
  • Regulatory Affairs


Quality Control (QC) is responsible for all analyses. From analytical support to validations, QC is supported by a highly qualified team of professionals.

Quality Assurance (QA)

  • is responsible for implementation of quality systems and release of all manufactured products.
  • develops and ensures harmonisation of all systems throughout the organisation. It is also responsible for all audits including regulatory (national and international), customer and GMP.


Regulatory Affairs ensures compliance with national and international regulatory requirements.


Quality Policy
Quality of our product is as much as it is perceived and appreciated by our customer.

Our quality objectives are:

  • Driving the business from customer needs
  • Commitment to comply all regulatory requirements
  • Setting a clear vision which is deployed down into coordinated action
  • Using contribution of every person to the full
  • Partnering with customers and suppliers (both internal and external)
  • Developing worker to manage and managers to lead
  • Becoming fast learner and more responsive to market opportunities
 

Accreditations & Approvals: (Mandi - Himachal Pradesh) 

·        WHO – GMP
·        FAMI-QS
·        BS OHSAS 18001:2007
·        HACCP
·        HALAL
·        KOSHER
·        US FDA EIR
·        Vegetarian Society Certificate
·        American Vegetarian Association Certificate
·        BRC
·        FSSC
·        FSMA
·         ISO 9001 - 2015
·        ISO 14001 - 2015

Accreditations & Approvals: (Dahej - Gujarat)

·        WHO – GMP
·        FAMI-QS
·        OHSAS 18001:2007
·        HALAL
·        KOSHER
·        HACCP
·        BRC
·        FSSC
·        FSMA
·        ISO 9001 - 2015
·        ISO 14001 - 2015

Accreditations & Approvals: (Others)
·        NSF Certification

 


 
Both the manufactutring units are registered with US FDA "Food Facility Registration Module (FFRM)"

Following is the list of regulatory filings and dossiers:

 

  Sr. No.

  Name of Product

  Country of Submission

1

  Cholecalciferol

  EDQM-CEP # R1-CEP 2007-292-Rev 01 (Mandi-Himachal Pradesh site)

  EDQM-CEP # R0-CEP 2016-266-Rev 00 (Dahej-Gujarat site)

  Health Canada (DMF # 2011-131)

2

  Vitamin D3 1.0 MIU in Soybean Oil

  Health Canada (DMF # 2015-205)

3

  Vitamin D2 1.0 MIU in Soybean Oil

 Health Canada (DMF # 2016-020)

4

  Vitamin D3 Resin 4.0 MIU in Soybean Oil

 Animal Feed Division - Canada

 

 

 

FBL News & Events Meet us at CPhI India Bombay Convention & Exhibition Centre Mumbai 28 30 November 2017
Fermenta Biotech Ltd invites you at CPhI India  - Bombay Convention & Exhibition Centre, ...
Meet us at CPhI Worldwide Messe Frankfurt Germany 24 26 October 2017
Fermenta Biotech Ltd invites you at CPhI Worldwide  - Messe Frankfurt, Germany - 24 -...
Article in Modern Pharma - Peter Bains
Green manufacturing in Pharma : On an Impact Mode, Peter Bains, Chairman - Fermenta Biotech Ltd ...
Business Division
Penicilling AcylaseSilicon PowderVitamin D3Bioremediation

Fermenta Biotech Ltd