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31-03-2010
Seminar on
VALIDATION OF EQUIPMENT
Prepared by:
Jayesh P. DobariyaM.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
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.
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.