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Keeping up with current regulatory trends

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  • 1. Keeping Up with Current Regulatory Trends Carole Crowe Agilent Technologies Validation Week IVT18 October 23, 2012 Crowe - 18th Annual Validation Week1 October 23, 2012
  • 2. Quality SystemsGuidance for Industry: Quality System Approach to Pharmaceutical cGMP Regulations Crowe - 18th Annual Validation Week2 October 23, 2012
  • 3. ICH Q10 Pharmaceutical Quality System ICH Q10 ( Management responsibility) … : ‘Leadership is essential to establish and maintain a companywide commitment to quality and for the performance of the pharmaceutical quality system’ Crowe - 18th Annual Validation Week3 October 23, 2012
  • 4. Major Reasons for Recalls(OTC and Rx) – FY 2010 – 2012*Year Top Reasons2010 GMP Deviations Temperature Abuse Marketed without an Approved NDA/ANDA2011 Penicillin Cross Contamination GMP Deviations Marketed without an Approved NDA/ANDA2012 Penicillin Cross Contamination Microbial Contamination of Non-Sterile Products GMP Deviations 2012* - as of 3/7/2012 Crowe - 18th Annual Validation Week4 October 23, 2012
  • 5. European 2012 PDA/EMA Joint Conference Compliance: A prerequisite for Availability of Medicinal Products Crowe - 18th Annual Validation Week5 October 23, 2012
  • 6. What is Compliance? And How Do We Enforce it? Crowe - 18th Annual Validation Week6 October 23, 2012
  • 7. FDA ComplianceThe Food and Drug Administration (FDA) is an agency of the U.S. federal government. The FDA is responsible for regulating the safety of food, drugs, cosmetics, biological products, medical devices, and consumer products that emit radiation. It has the power to establish federal rules and regulations about these products. FDA compliance is the act of following these regulations Crowe - 18th Annual Validation Week7 October 23, 2012
  • 8. Crowe - 18th Annual Validation Week8 October 23, 2012
  • 9. www.fda.gov/downloads/ICECI/EnforcementActions Crowe - 18th Annual Validation Week9 October 23, 2012
  • 10. FDA Warning Letter Trends Fiscal Years 2004 - 2012 2767 ? 3000 2800 2600 2400 2200 2000 1720 1800 1600 1400 1200 1000 725 673 800 535 538 471 474 600 445 400 200 0 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Crowe - 18th Annual Validation Week October 23, 2012Page 10
  • 11. How Do We Enforce It? Approximately 1 in 6 FDA 483 Inspectional Observations Results in a Warning Letter… Do You Feel Lucky ? Crowe - 18th Annual Validation Week11 October 23, 2012
  • 12. Quality Systems Crowe - 18th Annual Validation Week12 October 23, 2012
  • 13. Regulatory Landscape• USP <1058> - New Stimuli Paper for updates •  GAMP 5 rev. 2– Computer Systems Validation •  FDA Compliance Program Guide - Data Integrity •  21 CFR Part 11/Annex 11 Crowe - 18th Annual Validation Week13 October 23, 2012
  • 14. 4Q Stages of Instrument Qualification… Does it Does it Meet your USER Installation WORK as YOU EXPECTED Performance REQUIREMENTS Qualification Qualification DQ IQ OQ PQ Has it been Will it Design INSTALLED Operational CONTINUE to CORRECTLY work Qualification Qualification CORRECTLY But, no “Set Rules”, Regulators / Consultants / Scientists / Customers don’t Agree on the detail: •  WHAT - Some of The Stages Contain •  HOW - Often an OQ should be Done / RQ Vs OQ •  WHO - Performs Some of The Stages (OQ / PQ) Crowe - 18th Annual Validation Week14 October 23, 2012
  • 15. Instrument Life Cycle – From a Regulators 6 Perspective 1 Is the Instrument Re-Qualification Suitable for use (Justification) 2 Co Policy 5 2 Is it installed Maintenance Correctly 1 3 IQ DQ Use 3 Is there an SOP Are people Trained OQ 4 Is it Calibrated Breakdown Method Validation 6 Re-Qualification Repair 4 Failure Mgt. (Justification) Impact of Failure CAPA ? Justification: 5 Maintenance Routine ? OQ - How Often Frequent Customer Questions RQ – What to include 6 Re-Qualification / Calibration Crowe - 18th Annual Validation Week15 October 23, 2012
  • 16. 3 Categories on Instruments – USP <1058> “ Group A includes standard equipment with no measurement capability or usual requirement for calibration, where the manufacturers specification of basic functionality is accepted as user requirements” “Group B includes standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturers specification of functionality and operational limits” “Group C includes instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specific for the analytical application” Crowe - 18th Annual Validation Week16 October 23, 2012
  • 17. GAMP Changes GAMP Good Practice Guide GAMP - Validation of Computerized Laboratory Systems, moving away from 7 instrument categories to a fully RISK BASED approach. More Flexible: – Risk Based – Not Prescriptive – Will include examples – Better GAMP - <1058> Alignment GAMP 5 rev 2 – Flow chart to support use (Amazon Bestsellers Rank: 1,031,332) Crowe - 18th Annual Validation Week17 October 23, 2012
  • 18. Data Integrity Crowe - 18th Annual Validation Week18 October 23, 2012
  • 19. FDA Regulation 21Part CFR 11 Requirements Validation of computerized systems, Limited and authorized access to computer systems E-records and signatures Electronic audit trail Accurate and complete copies of records, Instant Availability of e-records Crowe - 18th Annual Validation Week19 October 23, 2012
  • 20. FDA Regulation 21Part CFR 11 Crowe - 18th Annual Validation Week20 October 23, 2012
  • 21. The Paperless Advantage The benefits of a paperless lab •  Improves efficiency, reduces risk • Positions you better for the future with Regulatory Agencies going paperless • Streamlines the review process for faster turnaround times • Maintains a complete audit trail • Reduces the cost of archiving paper and the risk of lost or damaged documents Crowe - 18th Annual Validation Week21 October 23, 2012
  • 22. Keeping Up With Regulatory TrendsBest in class companies – keep current with the latest FDA and USP directions and regulations on analytical instrument qualification – continually review and adapt their corporate master validation plan to evolve with advancing technology – take a “risk-based” and “science-based” approach to define the exact tests necessary for qualification – document and demonstrate a state of control across their manufacturing organization Crowe - 18th Annual Validation Week22 October 23, 2012
  • 23. Questions ? Crowe - 18th Annual Validation Week23 October 23, 2012