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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) 
·        Certificate of suitability for Cholecalciferol
·        WHO – GMP
·        ISO 9001:2008
·        ISO 14001:2004
·        FAMI-QS
·        BS OHSAS 18001:2007
·        HACCP
·        HALAL
·        KOSHER
·        US FDA EIR
·        Vegetarian Society Certificate
·        American Vegetarian Association Certificate
 

Accreditations & Approvals: (Dahej - Gujarat)
·        ISO 9001:2008
·        ISO 14001:2004
·        FAMI-QS
·        OHSAS 18001:2007
·        HALAL
·        KOSHER
·        HACCP
·        BRC

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

  European Directorate for the Quality of Medicines (EDQM) (R1-CEP 2007-292-Rev 01)

  Health Canada (DMF 2011-131)

  US Food And Drug Administration (DMF Number 025584) USFDA

  European Food Safety Authority (EFSA)

  State Registration ‘The Republic Of Belarus, Republic Of Kazakhstan
  And Russian Federation’

  Republic of Turkey Ministry of Health

  Iran

2

  Vitamin D3 500 Feed Grade

  Russian Federation

  Iran

  Canada

3

  Vitamin D3 1.0 MIU in Soybean Oil

 Health Canada (DMF 2015-205)

4

  Vitamin D2 1.0 MIU in Soybean Oil

 Health Canada (DMF 2016-020)

5

  Phenyramidol HCl

  Central Drugs Standard Control Organization, India (CDSCO)

  National Agency For Food And Drug Administration And Control; Nigeria (NAFDAC)

6

  Silicon Powder

  Republic of Turkey Ministry of Health

 

 

 

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