Hardware :
A) Site Zoning and Plant Layout, Zoning of Buildings with Specifications for Ceiling, Flooring and Wall Finishes.
B) Equipments Selections with Specifications for MOC of Manufacturing. Vessels and Machinery with Support Equipments, QC and QA Instruments, Wet Chemistry Labs, R & D and Pilot Plant Equipments and Packing Machinery.
C) Utilities and Services such as Boiler Piping, Instrumentation, Tank Farm, DM water Plants, water for Injections, HVAC with Specifications of Air Filtration area – wise (Classifications).
D) Turnkey Supply of Machinery, equipments & utilities.
Software :
A) Documents for Polices, SOPs, Batch Mfg.-Records, QC/QA System and other CGMP documents e.g. Change Control, Cleaning Validation, and GLP etc.
B) Qualifications and Validations done on I a, b, c of hardware (URS, DQ, IQ, PQ)
Operations Aspects :
Training and availability of Trained personnel with documents on Training Policy, Process Validation, Automation, SCADA System, Monitoring and Control of Hard-ware, Software, Identification of Critical Control Parameters, Safety, Environment and Effluent Control etc.