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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.

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31-03-2010 Seminar on VALIDATION OF EQUIPMENT

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  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

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