Qualification of tablet press

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.


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 ?


List Of Documents verified in During IQ:

  1. User Requirement Specifications (URS)
  2. Purchase Order
  3. Operating and Maintenance Manual
  4. Mechanical Drawing
  5. Electrical Diagram
    Verification Of Equipment
  6. Purchase Order Number and date
  7. Dimension of the equipment
  8. Physical verification of machine and its components for any damage
  9. Nature of damage, if any
  10. Corrective action in case of any damage.
  11. Hoppers
  12. Feed Frames
  13. Upper & Lower Pressure Wheels
  14. Lubrication System
  15. Guards
  16. Clutch Assembly
  17. Tooling
  18. Hand wheel- Weight adjustment.
  19. Tablet thickness wheel
  20. MMI
    Safety requirements
  21. Emergency button
  22. Upper and Lower guards
  23. Material of Construction
  24. 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,

for your question please call 805724 for answer it is free of charge. I can show you an example.

Best regards,

Hi,to all,

Can anybody provide the qualification protocol for the compression machine,…
thanks in advance.

Caplin poin Laboratories Ltd,INDIA.