Production plant shutdown and resumption of production steps
At the current stage, the provinces on the drug manufacturers to stop production, resumption of production requirements have not yet formed a unified specification, has been the implementation of the supervision of individual provincial drug supervision departments require companies: (1) drug manufacturers to suspend the production of 3-6 months and above, should be reported to the municipal level of the location of the drug supervision bureau for the record within 20 days prior to the stoppage, explaining the reasons for the suspension of production, The date of suspension of production, measures to deal with the intermediate products left behind, plant, facilities, equipment to maintain a continuous verification of the state of the approach, etc..
(2) drug manufacturers need to resume production to the local municipal Drug Administration to declare the request for resumption of production, if necessary, the Drug Administration should apply for resumption of production within five working days of the requirements of the production conditions and production quality management system to carry out on-site inspections, issued a "resumption of production on-site inspection report", requiring enterprises to correct defects in a limited period of time to rectify the project, and the rectification of the situation is verified. After the enterprise rectification in place, the on-site inspection will be reported to the provincial Drug Administration Drug Production Supervision Department within 10 working days. For enterprises that do not apply before resumption of production, municipal-level drug regulatory bureaus should interview the main person in charge of the enterprise and increase their daily supervision and product sampling and testing, and should be dealt with seriously in accordance with the relevant laws and regulations if they are found to have violated the law.
Second, the reasons for the suspension of production:
(1) production cycle, market demand reasons, the use of intermittent production mode of organization of production, the emergence of a phased suspension of production, in order to save variable costs.
(2) Production line renovation, plant relocation, production line adjustment, production equipment upgrading, there will be a phased shutdown.
(3) Staged production stoppages will be required for the sterilization of workshop space in regular production by the required due date.
(4) Shortage of raw materials, environmental pressure, financial constraints caused by production stoppages.
(5) quality standards improve, frequent flying inspections, forcing some companies to stop production.
Three, the production workshop shutdown notes:
(1) according to the requirements of the clean room, equipment, appliances for clean room.
(2) Close all equipment water, electricity, steam (gas) switch.
(3) the entire clean area for a disinfection process.
(4) The workshop raw and auxiliary materials, packaging materials back to the warehouse, intermediate products in accordance with the provisions of the storage conditions and location.
(5) All doors, windows, dust traps, etc. must be closed.
Fourth, the production workshop to resume production before the preparation:
(1) equipment air operation and overhaul, maintenance.
(2) General production area and clean area thoroughly clean.
(3) Wipe and disinfect the ceiling, wall, floor and floor drain of the clean area.
(4) Disinfection of ambient air in the clean area.
(5) environmental monitoring of the clean area.
(6) After the environmental monitoring results are qualified, the production operation can be carried out.