This presentation was made to solely for students to make them aware/ understand basics of “Instrument Qualification/Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from various books and websites

1. Pharmaceutical Validation
Dr. ARTI R. THAKKAR
This presentation was made to solely for students to make them aware/ understand basics of
“Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from
various books and websites

2. TYPES OF QUALIFICATION

3. TYPES OF QUALIFICATION /
PHASES OF VALIDATION
1. DESIGN QUALIFICATION / Pre-Installation Qaulification (DQ)
2. INSTALLATION QUALIFICATION (IQ)
3. OPERATIONAL QUALIFICATION (OQ)
4. PERFORMANCE QUALIFICATION (PQ)

4. INSTALLATION QUALIFICATOIN
 It is defined as the performance and documentation of tests to ensure
that equipment, machines used in manufacturing process, are
appropriately selected, correctly installed and work in accordance with
the established specifications.
 The IQ phase will be executed with personnel of the Supplier of
technical system or with technical personnel of pharmaceutical
company. It will follow the procedures set out in IQ protocols. After
performing the IQ, the results are summarized and in an IQ report.

5. IMPORTANT ASPECTS OF IQ
1. Develop an IQ protocol
2. Approve the protocol
3. Perform the IQ
4. Work out the IQ report
5. Approve the IQ report by QA, production and technical departments.
Attention should be paid to the calibration reports and
instrumentation and checking that the documentation is complete.

6. IQ PROTOCOL
• Name of the system and qualification number
• Documentation of owners manual, service, and maintenance.
• Test description
• Acceptance criteria
• Actual values
• Result (accepted or not accepted)
• Author of protocol, date, his signature
• Approval of action taken, date, signature
• Person in charge of execution, date, signature
• Approval of results, date, signature

10. OPERATIONAL QUALIFICATION
 It is a documented evidence that the system or sub system performs as
intended throughout all anticipated operating ranges.
 It tests whether or not the system works as expected.
Approach followed:-
 Develop OQ protocol
 Approve OQ protocol
 Perform OQ
 Work out the report
 Approve OQ report

11. TESTS IN OPERATIONAL QUALIFICATION
• Behavior of system after energy breakdown
• Accuracy of filling lines
• Transportation speed in sterilization tunnel
• Temperature distribution in hot air oven, incubator, autoclave
• Accuracy of weighing system
• Resolution power of the spectrophotometers

12. OQ PROTOCOL
1. Date of writing the protocol
2. Name of the system
3. Name of the supplier
4. Location or exact address
5. Description of execution
6. Necessary documentation
7. Documentation of actual values
8. Comment/remark/corrective actions

13. OQ PROTOCOL

14. OQ PROTOCOL

15. PERFORMANCE QUALIFICATION
PQ is the phase in which a technical system is tested over a
longer period of time to determine if it is consistently
producing a quality product.
It should follow approved protocol. Combining OQ and PQ
decreases the number of documents and cuts approval time
and effort.

16. Documentation

17. Thank you