hi i am working for one small pharmaceutical company. recently our company bought one used tablet press.I have to do qualification of this tablet press. can any one guide me about what information should i include in my IQ, OQ and PQ. Any help will be appreciated.
Dear,
The IQ, OQ and PQ of a tablet press as follows:
Installation Qualification:
i) Selection of members for Qualification
ii) Purchase Order verification
iii) Installation Checks
iv) Utilities Checks
V) Drawing and manuals checks
vi)Material of construction of contact parts and non-contact parts
vii) Major components verification
viii) operating procedures identification
Operational Qualification:
i) Calibration of all the instruments
ii) verification operating procedures
iii) Safety features Testing
iv) Performance of motor verification
v) critical parameters testing
Performance Qualification:
i) RPM study(Sampling at different rpm minimum, maximum and optimum)
ii) Hopper study at maximum rpm.
Only RPM test and Hopper Study is sufficient for performance qualification of tablet press machine ?
Anil
List Of Documents verified in During IQ:
- User Requirement Specifications (URS)
- Purchase Order
- Operating and Maintenance Manual
- Mechanical Drawing
- Electrical Diagram
Verification Of Equipment - Purchase Order Number and date
- Dimension of the equipment
- Physical verification of machine and its components for any damage
- Nature of damage, if any
- Corrective action in case of any damage.
- Hoppers
- Feed Frames
- Upper & Lower Pressure Wheels
- Lubrication System
- Guards
- Clutch Assembly
- Tooling
- Hand wheel- Weight adjustment.
- Tablet thickness wheel
- MMI
Safety requirements - Emergency button
- Upper and Lower guards
- Material of Construction
- Identification of the Instruments to be calibrated:
Is it necessary to perform requalification of tablet press or in-process control of tablets is enough to keep it under control?
And if it is necessary, what is the due for requalification and what test to repeat?
Dear joksavs,
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Best regards,
Hi,to all,
Can anybody provide the qualification protocol for the compression machine,…
thanks in advance.
Regards,
Ramajayam,
Caplin poin Laboratories Ltd,INDIA.