This document summarizes a seminar presentation on validation of equipment. It discusses the objectives and main parts of the validation process, including installation qualification, operational qualification and performance qualification. It provides an example of validating a dissolution test apparatus, describing specific tests run during installation qualification and operational qualification. Finally, it mentions that process analytical technology will add new dimensions to equipment validation in the future.

1. 31-03-2010
Seminar
on
VALIDATION OF EQUIPMENT
Prepared by:
Jayesh P. Dobariya
M.Pharm. Sem-II
Roll no. 04
Department of Pharmaceutics,
Maliba Pharmacy College, Bardoli.

2. Outlines
 Introduction
 Parts/steps of qualification
 Role of FDA in equipment validation
 Example of equipment validation
 Future of equipment validation
 References

3. Introduction
Objectives:
 Improvement of overall production reliability and
availability
 Safety
 Fewer interruptions of work
 Lower repair costs
 Elimination of premature replacements
 Less standby equipment
 Identification of high maintenance cost
 Reduction of variation in results
 Greater confidence in reliability of results

4. Parts of qualification

5. Cont…
 Preliminary steps:
-Project Management
-Equipment Master Plan
-User Requirement Specification
-Design Qualification(DQ)

6. Cont…
 Other main parts of equipment
validation:
- Installation Qualification(IQ)
- Operational Qualification(OQ)
- Performance Qualification(PQ)
- Change control & Requalification

7. Role of FDA in EQ
 The Validation process is regulated by the
guidelines & restrictions set forth by the FDA.
 CFR: Code of Federal Regulation
created by US Government that sets guidelines
pertaining for food and drugs.
 Validation rules are given in the 21 CFR Part
210 & Part 211 as the part of cGMP.

8. Example of EQ
Dissolution test apparatus
validation

9. Cont…
Installation Qualification:
 Following points are to be considered.
1.Preventive maintenance of Dissolution Apparatus.
2.Utilities
3.Environmental conditions:
As per the USP standards,
“The dissolution Apparatus should be kept in an
environment that do not provide additional
motion/agitation/vibration to the rotating element of
the apparatus.”

10. Cont…
Operational Qualification:
 It is also known as system suitability test
 Performed using USP Calibrator tablets:
USP Prednisolone Tablets (disintegrating type)
USP Salicylic acid Tablets (non-disintegrating type)
 Test is considered successful if the percent of drug
released within 30 min. falls within the pre-established
range.
 This test must be conducted for each of the vessels
contained within a dissolution apparatus.

11. Cont…
Some additional tests:
As per the guidelines of Validation for
Dissolution test Apparatus,
 It is mandatory to perform
1.Temperature Distribution Study &
2.Rotation Speed Study

12. Future of EQ
 PAT (Process Analytical Technology)
will add new dimensions to the
Validation in future.

13. References
 www.pharmatech.com/pharmatech/article detail.jsp?
id+128855
 WWW.DISSOLUTIONTECH.COM
 Introduction to a validation of dissolution apparatus,
Sharon m Averell frost, Dissolution Technologies, Feb
2004, Vol. 11.