PQ Methodology and Validation Matrix for Compression Machine
VALIDATION PLAN AND METHODOLOGY
Performance of the Double Rotary Tablet Compression Machine shall be tested at extreme and optimum operation conditions, which are identified as...
Performance Qualification – LAF (Laminar Air Flow)
Laminar Air Flow (LAF) Work Station is capable of maintaining a particulate free work area even when operated in an uncontrolled environment. This is...
PQ of Blender (V-shape)
V Blender is used for mixing of active ingredients along with excipients and lubricants.
PQ of V Shaped Blender
Prerequisites
Verify all SOPs are available and...
Design Qualification of Vertical Laminar Reverse Flow Powder Containment Station
OBJECTIVE
To design, engineer and supply the Vertical Laminar Reverse Flow Powder Containment Station to provide assurance that the machine is manufactured as...
Establishing the minimal and maximal optimum speed during qualification of blender
Procedure for establishing minimum optimum speed:
Run the machine as per the standard operating procedure. Set the lowest RPM possible and run the machine for...
Equipment qualification..Basic approach..!!!
Equipment qualification
Equipment qualification performed to “Establish confidence that process equipment and ancillary system are capable of consistently operating within established limit and tolerance”
User requirement...
Basics of Equipment Qualification
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance.
Need of Qualification
To manufactured a quality product
Proof “suitability...
