Equipment Qualification- Preformulation and production management.

1. Prepared by : Deepak Kumar
Pharmaceutics dept.(M-Pharm-1st Year)

2. Equipment Qualification Of
Processing Equipment:-
Components of qualification:-
a) Design Qualification
b) Installation Qualification
c) Operational Qualification
d) Performance Qualification
e) Re-Qualification

3. a) Design Qualification:-
 Specification required for equipment
 Performance prior to purchase
 Describe the feature required for the equipment
 Outlines the division process used to select the
equipment

4. Design Qualification consideration:-
 Capability (Ex - speed, capacity & temperature)
 Requirement (Ex – voltage,size limitation)
 Indicates the requirement the equipment must meet
equipment description
Specification:-
1. Electrical
2. Tolerence / Performance
3. Maintenance / Cleaning
4. Other

5. b) Installation Qualification :-
 When & Where required
 Condition upon received
 Transportation to site by use
 Installation
 Start-up
 SOP for maintenance & use
 Date of delivery
 Order complete
 Name of installer

6. c) Operational Qualification:-
Equipment function are described by manufacturer.
Operational Qualification for spray driers:-
 Does the spray drier turn on and off
 Work at programmed speed and temperature
 Retain programming

7. Describe specification to be tested:-
 Accuracy of setting, maintenance of temperature, etc.
 Has the equipment has been calibrated
 By whom SOP been written
 Calibration document is attached

8. d) Performance Qualification:-
 Does the equipment function correctly and consistency
for the intended application.
 Anologous to validation.
 Follows the SOP.
 Equipment operating procedures.
 Qualification of operator, operating the equipment.

9. e) Revalidation:-
 Whenever there occurs any deviation / changes in any
critical process parameters function of major
equipment, premises, etc.
 The entire process is to be checked from the
beginning and to be initiated according to the
protocol.
 Until and unless it coincides validation parameters, no
processes can be carried out.

10. Thank you