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Regulatory Issues in Sterile Compounding

Regulatory Issues in Sterile Compounding. Fran McAteer. USP <797> Regulatory Authority/Site Inspections. United States Food and Drug Administration (FDA) USP <797> Code of Federal Regulation CFR 200-1000 Good Manufacturing Practices MA Department of Public Health (MADPH)

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Regulatory Issues in Sterile Compounding

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  1. Regulatory Issues in Sterile Compounding Fran McAteer

  2. USP <797> Regulatory Authority/Site Inspections • United States Food and Drug Administration (FDA) • USP <797> • Code of Federal Regulation CFR 200-1000 • Good Manufacturing Practices • MA Department of Public Health (MADPH) • Draft Engineering Regulations New Section 247 CMR 6.15, November 1, 2012 • Mass General Law (MGL) Chapter 94C Section 21 Chapter 112, Section 61 • DPH Regulations 105CMR721.000

  3. USP <797> Regulatory Authority/Site Inspections MA Board of Pharmacy (MABOP) United States Department of Drug Enforcement (DEA) Center for Disease Control (CDC)

  4. 797 Compliance Assessment Tools United States Pharmacopeia (USP)35 National Formulary (NF)30 <797> Pharmaceutical Compounding – Sterile Preparations2012 International Journal of Pharmaceutical Compounding Gap Analysis Survey Compounding Sterile Preparations USP <79> 2012 Massachusetts Pharmacy Board Draft Emergency RegulationsNovember 1, 2012

  5. 797 Compliance Assessment Tools Pharmacy Compounding Accreditation Board PCAB Accreditation ManualAugust 25, 2012 Food and Drug Administration (FDA) Inspectional Observations New England Compounding Center (NECC)October 26, 2012

  6. 797 Compliance Assessment Tools Food and Drug Administration (FDA) Inspectional Observations Ameridose LLCNovember 9, 2012 International Academy of Compounding Pharmacists (IACP) Compounding Pharmacy Assessment Questionnaire(CPAQ)2012 American Society of Health System Pharmacists (ASHP) Outsourcing Sterile Products Preparation Contractor Assessment Tool2011

  7. 797 Compliance Assessment Tools International Standard Organization (ISO) 14644-1 Cleanrooms and Associated Controlled Environments1999 USP35 NF30 <71> Sterility Tests2012 USP35 NF30<85> Bacterial Endotoxins Tests2012 USP35 NF30 <71> Microbiological Control and Monitoring of Aseptic Processing Environments 2012

  8. USP <797> Overview Medium High Low Secondary Engineering Controls (SEC) ISO 7 Chemical Stability Data HVAC Controls including ACPH/ Differential Pressure/ Velocity/ Temperature/ Humidity USP <85> Endotoxin Testing USP <71> Sterility Testing Didactic Training 0.5µ & 5.0µ Particles Measurement Volumetric Air Sampling Continuing Educational Seminars Bacteria, Yeast & Molds Surface Sampling Proficiency Testing Hand Hygiene Personnel Media Fill Aseptic Technique Glove/ Fingertip Garbing Proficiency Fingertip Testing Documentation Control Policies Simplifi 797 Software Recipes/ Batch Records

  9. PharMedium FDA 483 Observations

  10. PharMedium FDA 483 Observations

  11. PharMedium FDA 483 Observations

  12. CAPS FDA 483 Observations

  13. CAPS FDA 483 Observations

  14. CAPS FDA 483 Observations

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