Transcript Seminar on VALIDATION OF EQUIPMENT

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.
Outlines
Introduction
 Parts/steps of qualification
 Role of FDA in equipment validation
 Example of equipment validation
 Future of equipment validation
 References

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
Parts of qualification
Cont…

Preliminary steps:
-Project Management
-Equipment Master Plan
-User Requirement Specification
-Design Qualification(DQ)
Cont…

Other main parts of equipment
validation:
- Installation Qualification(IQ)
- Operational Qualification(OQ)
- Performance Qualification(PQ)
- Change control & Requalification
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.
Example of EQ
Dissolution test apparatus validation
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.”
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.
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
Future of EQ

PAT (Process Analytical Technology) will
add new dimensions to the Validation in
future.
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.