Information Based Inspections of 25 Pharma Units
Information Based Inspections were carried out at 25 Pharmaceutical Manufacturing Units from 18th to 20th Sept 2015.
The aim of these inspections is to ascertain and ensure that Good Manufacturing Practices are being followed by these manufacturers.
Each of the manufacturing unit was inspected by a team headed by an Assistant Director and 2 Drug Inspectors. The inspections were spread over 2 days per unit.
Teams underwent detailed briefings and instruction w.r.t the Inspection procedures to be followed.
Shuffling – As has been the recent practice, the teams and areas were shuffled. Each team was sent to an area other than his original jurisdiction.
Action:
In 2 cases, registration of specific cases.
Drugs worth Rs. 33.75 lakhs have been 'frozen' and declared ' Prohibited for sale'.
In 23 Cases, Issuing of Show Cause Notice asking for:
Explanation and hearing the version of themanufacturer
Collection of details of products dispensed or sold.
Legal action- Stop Production Orders.
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