SOP on Opening and closing of Quality Control Laboratory
PURPOSE: To define procedures for opening and closing of the Quality Control department.
SCOPE: This SOP is applicable for the quality control department and includes a microbiology section, instrument section, physical-chemical section, stability section, record, room, main entrance, etc.
RESPONSIBILITY
QC Person: To open & lock the department & submit the keys at the security office.
Head QC: To ensure implementation of the defined system.
PROCEDURE
Opening of the Laboratory:
Department keys shall be available at the security gate.
Take department key of the department available at security gate.
Take entry into the department as per defined entry/exit procedure.
Open the main gate of the department & subsequent section thereafter.
Switch on the light of each sections including corridor after opening the door.
Switch on the exhaust of fuming cup board, air conditioners or AHU of the department.
Follow the same procedure for stability department.
Make necessary entries wherever applicable.
Check the water level in the tank for supply to stability chambers.
Inform to senior if any adverse observations are observed.
Keep all the keys into Manager room or at designated place in a key holder.
Closing of QC Laboratory:
At the end of working day, take out keys from key holder.
Ensure that all equipments switches are in off position.
Tag status board on the equipments which running in night shift also.
The equipments run round the clock shall always remains in on position & the person responsible to open & close the laboratory should be aware.
Switch off the mains of particular section if all equipments remains off in night.
Ensure tank water level of stability section before closing the department.
Lock the main entrance of the department & get deposited the keys at main security gate
Precautions
During lab closing one person should accompany the responsible person for closing.
Ensure that all electric switches are off which is not require.
Keys shall be issued to authorize person only, if anyone other than authorize person require the key prior permission to department head or authorize person is require.
