Risk based approach to revalidation programs

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"Risk-based Approach to Revalidation Programs" Webinar, presented by Tara Graf, Transcat's Validation Manager on November 14, 2013 at 2:00pm EST

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Risk based approach to revalidation programs

  1. 1. Risk‐based Approach to   Revalidation Programs By:  Tara Graf, Transcat’s Validation Manager 11/14/2013
  2. 2. Agenda • What does the FDA requirement mean for What does the FDA requirement mean for  revalidation programs? • Why is the criticality of the equipment an  important factor? i f ? • Why should critical equipment be revalidated  y yearly? y
  3. 3. FDA Stance / Transcat FDA Stance / Transcat Stance • The FDA does not give specifics around The FDA does not give specifics around  revalidation interval or activities.  The FDA  does focus on control over your system. does focus on control over your system • A revalidation program requires that all  systems that require validation, as defined by  systems that require validation as defined by a specific quality system, are evaluated on a  specified interval. specified interval
  4. 4. Critical Equipment Critical Equipment • Definition:  Instruments used to manufacture a drug,  chemical or product  h i l d t • Examples:  Fermentors, Bioreactors, HPLC Units,  Dissolution Units, Lyophilizers, Water Systems,  Dissolution Units Lyophilizers Water Systems Compressed Air Systems, etc. • Service Actions:  Annual Calibration and Validation  • Validation Actions:  Test to ensure the equipment  functions the way it was designed to and is still suiting  the need of the process.
  5. 5. Secondary Equipment Secondary Equipment • Definition:  Instruments used to store or test the intermediate  or final products created from a regulated process f l d df l d • Examples: Autoclaves, Depy Ovens, Glassware Washers,  Viscometers, Controlled Temperature Units ‐‐for bulk  intermediate or final product store, or sample retain storage‐‐,  i t di t fi l d t t l t i t microplate readers, spectrophotometers, centrifuges, etc. • Service Action:  Annual Calibration, Bi‐annual Revalidation (at  a minimum)  a minim m) • Validation Action: Prove the equipment is functioning  properly and doing its part in the overall process. Such as, re‐ mapping a chamber, checking the photometric accuracy of a  mapping a chamber checking the photometric accuracy of a spectrophotometer, testing a loaded centrifuge chamber etc. 
  6. 6. Tertiary Equipment Tertiary Equipment • Definition:  Equipment used in a regulated facility that may monitor  a process, used to store media or buffers, used to crudely weigh a  a process sed to store media or b ffers sed to cr del eigh a buffer solution, etc.  • Examples:  Refrigerators, freezers, controlled temperature units,  not holding intermediate or final product, pH meters, conductivity  meters, balances, etc. • Service Actions: Annual calibration, Revalidation set interval not  , necessary • Validation Actions:  Continually monitor functionality for negative  trends as a sign of revalidation need or replacement. Such as  trends as a sign of revalidation need or replacement Such as temperature has started to decline, conductivity readings for known  point of use spots are out of the ordinary, balance is showing drift  and not zeroing out with no weight.   and not zeroing out with no weight
  7. 7. Summary • The interpretation of the regulations is up to The interpretation of the regulations is up to  the dedicated quality system of each company  but a major element that needs to be present  but a major element that needs to be present in all revalidation programs is control. • The criticality of the equipment should and The criticality of the equipment should and  will impact the amount of revalidation or  calibration performed on it and the frequency  calibration performed on it and the frequency of the re‐testing.
  8. 8. Contacts • Validation Technical Questions: Validation Technical Questions:   – Tara Graf: tgraf@transcat.com • Validation Projects Needs: – Alisha Powers: apowers@transcat.com

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