Purpose :
The purpose of this SOP is to describe the setting, operation and cleaning procedure of Rapid Mixer Granulator Machine (Model: M-150) in order to comply with cGMP standard.
Scope :
The scope of the procedure is applicable to the Rapid Mixer Granulator Machine (Model: M-150) at the Production area of XX Pharmaceuticals Limited.
Definitions / Abbreviation:
PLC : Programmable Logic Controller
CIP : Clean In Place
Responsibilities:
The roles and responsibilities are as follows:
Operator
Operation and cleaning of the Rapid Mixer Granulator Machine (Model: M-150).
Maintaining Equipment Log Book.
Executive, Production
To monitor and check the laid down procedure.
Manager, Production
To implement this correctly.
Manager, Quality Assurance
To approve the Document.