1 / 15

31-03-2010 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. Outlines. Introduction Parts/steps of qualification Role of FDA in equipment validation Example of equipment validation Future of equipment validation References.

tauret
Télécharger la présentation

31-03-2010 Seminar on VALIDATION OF EQUIPMENT

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 31-03-2010Seminar onVALIDATION OF EQUIPMENT Prepared by: Jayesh P. Dobariya M.Pharm. Sem-II Roll no. 04

  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, “Thedissolution 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.

  14. Thanks

More Related