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 ManagementProject 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.pharmatech.com/pharmatech/article  WWW.DISSOLUTIONTECH.COM WWW.DISSOLUTIONTECH.COM  Introduction to a validation of dissolution apparatus, Sharon m Averell frost, Dissolution Technologies, Feb 2004, Vol. 11.