31-03-2010

Seminar on

VALIDATION OF EQUIPMENT

Prepared by:Jayesh P. DobariyaM.Pharm. Sem-IIRoll 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 Regulationcreated 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 EQDissolution test

apparatus validation

Cont…Installation Qualification:

Following points are to be considered.

1.Preventive maintenance of Dissolution Apparatus.2.Utilities3.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.