MANUFACTURING FACILITIES

Vital has two manufacturing facility situated at GIDC- Vapi (Gujarat)-160 Kilometers from Mumbai-accessible both by road and rail and is spread over a land area of 7701.86 sq meters & 15336 sq meter having built up area of 44000 sq feet. & 1, 10000 square feet respectively

The Company has developed dedicated GMP facility for accreditation of:

1. WHO Geneva Approval
2. EDQM Approval
3. USFDA Approval

The facility has been inspected by EDQM for CEP/COS of Quinine Sulphate (CEP 2005-117) and Quinine hydrochloride (CEP 2005-114) and has now been approved   for cGMP Quality system ICH Q7 adopted by company and approved facility.

The main features for GMP facilities are:

1. 6 (Six) separate production lines with GMP which comply norms under EUGMP, USFDA and WHO Geneva Guidelines. Two more Production Lines  are expected to be functional by March’2010.  
   
   
2. All Major Equipments are made out of Special Steel (SS 316) which has been designed for easy cleanability to avoid cross contamination
   
   
3. The Finished Goods Powder Processing Area has Class 100000 clean area that has absolutely no level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. The air entering a clean room from outside is filtered to exclude dust and the air inside is constantly re-circulated through high efficiency particulate air (HEPA) and/or ultra low penetration air (ULPA) filters to remove internally generated contaminants.
   
   
4. Water Systems having Electro Polish Loop which are qualified for EP, BP Purified Water Systems have been installed. The electrolytic (electro polishing) bath smoothes, polishes, deburrs and cleans stainless steel and other metals by selectively removing high points on the metal surface. The amount removed depends first on the customers' specifications, but temperature, current density and the alloy in the electro polishing bath also affect the amount of metal removed.  
   
   
5. The QC Laboratory is well equipped having a Wet Chemistry lab, Instrument lab and Microbiology section.
   
   
6. Instrument Laboratory is equipped with the State of Art HPLC’s (5), HPLC with PDA detector for method development and validation, GC, GC_HS for OVI and Residual solvent analysis.