Quality Policy

Quality Policy

Neiss Labs is in tune with the current manufacturing trends in healthcare industry. Our manufacturing plants are WHO-GMP compliant. The manufacturing facilities are in compliance with major regulatory bodies around the world including MCA, TGA and MCC.
Being in the business of healthcare products, Neiss Labs acknowledges quality as the first and the foremost important aspect. The key ingredients of manufacturing process clearly indicate the Neiss Labs commitment towards quality, they are:


  • Exhaustive Specifications for Inputs & Outputs
  • Validated Manufacturing Methods
  • Stringent In-process Controls
  • Validated Batch Manufacturing Procedures
  • Validated & Approved Analytical Procedures
  • Independent Quality Assurance Department
  • Elaborate Standard Operating Procedures

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SALIENT POINTS


Water

Demineralization Plant and pipeline in loop form with a 5 micron filter and UV lamp for absolute purity of water Multicolumn Distilled water plant with storage & Distribution at through lines in closed loop. Still room with class D conditions

Labs

Well equipped Quality Control Laboratory with modular furniture including H.P.L.C. Microbiology & Sterility area under class 10,000.


Raw Materials

Dispensing of materials under reverse laminar flow Ample segregated storage for raw materials and packaging materials, with a quarantine facility Separate air handling units for every production departments, in addition to air conditioning with 3 micron filtration to ensure absolute product purity.


Air Handling Units (AHU)

Individual compression and coating cabins with separate air handling units to avoid cross contamination. Separate double skin Air Handling Units for vial/ampoule washing, sterilization, buffer zone and airlocks, filling areas confirming to class D, C, & B. Separate Air Handling Units for powder filling area


Miscellaneous

State of art vial / plastic dropper filling / sealing line for untouched operation. Visual inspection of ampoules with semi automatic inspection of machines. Extensive training and retraining of personnel to ensure they stay current with latest technological developments. Alternative power generation system for uninterrupted production A unidirectional flow of men and materials to promote optimum productivity. Accessibility of all utilities and maintenance areas from outside, for additional ease of operation.