79. [ Inspection before grant [***] [Substituted by G.S.R. 923(E), dated 14.12.1992 (w.e.f. 14.12.1992) as corrected by G.S.R. 373(E), dated 13.4.1993.] of license.
- Before a license under this Part is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f 21.12.1945).] the licensing authority or Central License Approving Authority, as the case may be, shall cause the establishment in which the manufacture is proposed to be conducted or being conducted to be inspected by one or more Inspectors appointed under the Act with or without an expert in the field concerned. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the drugs to be manufactured or being manufactured and enquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the "Requirements of Good Manufacturing Practices" and the "Requirements of Plant and Equipment" as laid down in Schedule M read with the Requirements of Maintenance of Records as laid down in Schedule U.]
