TYPE OF VALIDATION

1. A seminar on
Equipment validation
BY
SAI DHATRI ARIGE
V. V. institute of pharmaceutical science

2. Contents:
 Validation
 Types of validation
 Equipment validation
 Phases of equipment validation
 Dissolution apparatus validation
 conclusion

3. VALIDATION
Def:-Validation is an integral part of
quality assurance. It involves the
systemic study of systems, facilities and
processes they perform their intended
functions adequately as specified or not.

4. TYPES OF VALIDATION
 The validation is mainly divided into three
types:
1) Process validation
2) Product validation
3) Equipment validation

5. EQUIPMENT VALIDATION
Equipment validation is a program starts from
the decision to bring a new equipment into
organization and carry on till the end use full
life.

6. PHASES OF EQUIPMENT VALIDATION
Equipment validation mainly includes three
phases:
1. Pre qualification phase
2. Qualification phase
3. Routine operation phase

7. PRE QULIFICATION PHASE
It mainly includes:
a) Identify the needs
b) User requirements
c) Design qualification
d) Justification

8.  Design qualification:
The GMP texts specify various
requirements in respect to while designing
premises, utilities and equipment, these
requirements should be taken into
consideration.

9. QUALIFICATION PHASE
It mainly includes:
1)Site preparation
2)Commission protocol
3)Qualification
4)Review and Approval

10. 1)Site preparation:
 It includes:
a)Physical dimensions of the equipment
b)Suitable operating environment
c)Utilities
d)Health and safety requirements.

11. 2)Qualification:
 Equipment qualification is required to establish
the functional capacities and reliability of the
system for its intended use.
 It is divided into three stages:
a) Installation qualification
b) Operational qualification
c) Process qualification

12. Installation qualification:
GMP required that IQ should be performed
on new or modified facilities system and
equipment. It includes:
 inspection of delivery documents.
 Inspection of packaging to detect any physical
damage.
 Electrical testing.

13. Operational qualification:
As per GMP regulations the OQ include:
 Tests that have been developed from knowledge
of processes, system and equipment.
 The trails for OQ include
Replication of optimal values
Factorial design

14. Performance qualification:
– The PQ should include tests using production
materials, qualified substitutes developed form
the process and facilities.
– Test to include condition encompassing upper and
lower limit.

15. Routine operation phase:
 It mainly includes:
a)Standard operating procedure
b)Calibration verification
c)Maintenance

17. Installation qualification
 Preventive maintenance
 Calibration
 SOP’s
 Utilities
 Computerized system
 Environmental conditions

18. Apparatus1
 Vessel : Cylindrical, 160-210mm high, inside
diameter 98-106mm, nominal capacity is 1000ml;
sides are flanged at the top.
 Shaft: positioned so that its axis is not more than
2mm at any point from the vertical axis of the
vessel and rotates smoothly and without
significant wobble.
 Materials of construction: shaft and basket
components are stainless steel, type 316 or
equivalent.
 Basket position: the distance between the inside
bottom of the vessel and the basket is
maintained at 25+/-2mm during the test.

19. Apparatus2
 Vessel : Cylindrical, 160-210mm high, inside
diameter 98-106mm, nominal capacity is
1000ml; sides are flanged at the top.
 Shaft: positioned so that its axis is not more
than 2mm at any point from the vertical axis
of the vessel.
 Blade position: the distance between the
inside bottom of the vessel and the blade is
maintained at 25+/-2mm during the test.

20. Operational qualification
 System suitability (calibration)
Using USP calibrated tablets
Test is considered successful
Each of the vessel contained within dissolution
apparatus.
HPLC or UV/V
Acceptable peck resolution and elution time.

23. CONCLUSION
At the acceptable installation and
operational qualification, the dissolution
apparatus is considered validated and
acceptable foe use to perform dissolution
testing.