Plant setup
-
Conceptualisation
-
Facility Plan and Design or Layout
-
Total Engineering Support
-
Procurement Support
-
Installation- IQ, OQ, PQ Support
-
Commissioning and Qualification
-
Computer System development and Validation
-
URS, FRS, SAT and FAT support
-
Vendor Identification and Management
Plant Upgradation
If you already have the API or Formulation Plant which is approved by the local regulatory authority and if you want to expand your reach to regulated territories like USFDA, EMEA, WHO, MHRA, PIC/S etc then you May opt for Plant Upgradation Service,
Plant Upgradation Includes following,
-
Establishment of Proper scope for which regulatory is being targeted.
-
GAP Audit of Existing Plant (API/Formulation)
-
Preparation of GAP Audit Report,
-
Preparation of CAPA Plan,
-
Identification of GAPS and making time bound milestones for upgradation
-
Validation
-
Changes in Layout and design in required.
-
SOP and Procedures upgradation,
-
Policies redesign
-
Training
-
QMS system establishment/ restructuring as per requirement
-
Internal Audit System development