Sampling booth Purpose:
The purpose of this SOP is to describe the operation and cleaning procedure of Sampling Booth in order to comply with cGMP standard.
Sampling booth Scope :
The scope of the procedure is applicable to the Sampling Booth installed at the Warehouse of general block of XX Pharmaceuticals Limited.
Definitions/Abbreviation:
[][]SOP: Standard Operating Procedure
[][]QC: Quality Control
Responsibilities:
The Roles and Responsibilities are as follows:
Officer/Executive/Sr. Executive, Quality Control
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
Executive, Warehouse
[][]To ensure that this procedure is followed.
[][]To check & ensure cleaning of sampling booth.
Manager, Quality Control
[][]To confirm that the SOP is technically sound and reflect the required working practice.
[][]To arrange the training on the SOP to all concerned personnel and to ensure the implementation of the SOP after training.
Head of Quality Assurance
[][]To approve the Document
[][]To ensure the overall implementation of the SOP.
Procedure
Precautions:
[][]The working person must follow safety procedures of works.
[][]For any trouble, disturbance switch OFF the Sampling Booth.
[][]Don’t sampling solvent and flammable liquid inside the sampling booth
Operation
[][]Check the Sampling Booth first physically.
[][]Check electric connection and mechanical set up.
[][]Machine switch on.
[][]Light on and blower on.
[][]Open the door.
[][]After completion desired work clean the Laminar Unit properly.
[][]Close the door and switch off main switch.
[][]Switch ON Sampling Booth.
[][]Switch ON Light.
[][]Switch ON the Laminar Air Flow.
[][]Increase or decrease air flow by pressing up/down button.
[][]Operate the Sampling Booth for 30 minutes before starting sampling.
[][]Record the machine operation start time & end time and other parameters on the Equipment Log Book’
Cleaning
[][]Remove dust from the Sampling Booth with a vacuum cleaner and then clean with lint free cloth.
[][]Clean the booth with wet mop.
[][]Wipe the water with lint free cloth.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning status in the ‘Equipment Log Book’.
Download Here:
[][]Annexure I: Equipment Log Book