Qualifications

Conducting Qualification(URS,DQ,FAT,SAT,IQ,OQ,PQ and MQ) is not only a regulatory requirement, but also makes a great deal of sense from engineering as well as a business point of view .It is evident that pharmaceutical companies that are well versed in conducting Equipment Qualification  have a competitive advantage over those who are not.

To provide documented evidence, that production equipment including buildings, rooms, premises and utilities (water systems, HVAC, steam generator, a.o.) are installed and functioning within anticipated operating ranges and perform as intended and prescribed within the User Requirement Specifications (URS). Qualification activities normally are subdivided into DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) activities.
We provide high Quality qualification services for equipment, facilities, and utilities in pharmaceutical, biotech, medical devices, diagnostics, consumer products, cosmetics, herbal, ayurvedic and veterinary industries. Our experience includes projects ranging in size from qualification of a single piece of equipment to complete turnkey validation of equipment, facilities, utilities and processes in a start-up facility.

  • Equipment Qualification
  • Facility Qualification
  • HVAC/AHU System Qualification
  • Utilities like Water System/ Compressed Gases
  • Laboratory Instruments
  • Vendor Qualification
  • Computerized Systems
  • Temperature and Humidity Mapping of Storage Areas
  • We also provide tailor made ready to use URS, DQ,FAT,SAT, IQ,OQ,PQ and MQ protocols
  • Prerequisites
    1. Established Quality Management / Quality Unit System.
    2. Qualified and well trained personnel.
    3. Good Engineering Practice System in place (GEP).
    4. Basic engineering documentation (e.g. actual P&IDs