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1、2008, PAREXEL ConsultingFDA Inspection Preparation and Management Massachusetts Biotechnology CouncilApril 28, 2009David L. Chesney, Vice PresidentStrategic Compliance ServicesPAREXEL ConsultingD 978-848-22562008, PAREXEL ConsultingBasics for FDA Inspection Preparation and Management Understand and
2、respect FDAs inspection authority Be familiar with FDA Compliance Programs applicable to your industry sector Develop a company inspection management SOP Train staff so that they understand the process and can follow the SOP Emphasize the need for staff to be truthful and professional in their inter
3、actions with FDA Control the environment Communicate clearly during and after the inspection2008, PAREXEL ConsultingGeneral Caution This will be a rather quick summary of the key considerations in managing inspections. An in depth study and careful preparation on your part is needed. FDA inspections
4、 carry legal risk for the company and individuals For this reason, it is wise to include legal counsel in key decisions surrounding the management of FDA inspections The guidance in this presentation is intended to help inform you about some of the issues FDA inspections present, but is not intended
5、 to be legal advice, nor to include every aspect that companies should consider in their inspection preparation. Seek the guidance of counsel when finalizing inspection policy and procedure to ensure it is legally sound and properly crafted to protect the company in this important area.2008, PAREXEL
6、 ConsultingFDA Inspection Authority Section 704 of the Federal Food, Drug and Cosmetic Act (drugs and devices) we will abbreviate as the “FFDCA” Section 351(c) of the Public Health Service Act (licensed biologics) and 361 (tissue products) 21 CFR 600.22 (licensed biologics) 21 CFR 1270 (tissue produ
7、cts) As a practical matter, 704 of the FFDCA is the governing law2008, PAREXEL ConsultingFDA Inspection Authority Section 704, FFDCA: “Enter and inspect” At reasonable times, within reasonable limits, and in a reasonable manner For Rx drugs (including biologic drugs), “inspection shall extend to all
8、 things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use (made in the facility are in compliance or not)” “Reasonable Time, Limits and Manner” not spelled out in detail2008, PAREXEL Con
9、sultingReasonable Time, Limits and Manner Time: FDA can inspect any time regulated operations are taking place. The calendar and the clock do not establish what is “reasonable”; what is happening in the facility determines what is a reasonable time. Limits: You can insist that FDA stick to their aut
10、hority and not enter areas that would pose a danger to the product, facility, employees, or the FDA personnel, without appropriate controls. Manner: Lots of potential areas for conflict here, should be worked out in advance. A few examples include: Samples Photography Access to personnel and records
11、2008, PAREXEL ConsultingWhat FDA Must Do Show appropriate credentials Issue a Notice of Inspection (FDA-482) to the “owner, operator or agent in charge” Adhere to reasonable security precautions, safety rules, and standards/procedures for gowning or other protective garb while in production, warehou
12、sing or lab areas Issue the FDA-483, if any, to the same person (or designee) who got the 482 Issue a FDA-484, Receipt for Samples, for any product or material samples collected (does not apply to documents, only physical material)2008, PAREXEL ConsultingWhere to Look to Learn About FDAs Inspection
13、Procedures The Investigations Operations Manual, http:/www.fda.gov/ora/inspect_ref/iom/default.htm Concentrate on Chapters 2, 4, 5 and some of 8 Others of limited interest The applicable FDA Compliance Programs; for biologic firms, some of the most important are: 7345.848, Inspection of Biological D
14、rug Products, (CBER regulated) http:/www.fda.gov/cber/cpg/7345848.htm 7356.002M, Inspection of Licensed Biological Therapeutic Drug Products, (CDER regulated) http:/www.fda.gov/cder/dmpq/7356_002M.pdf 2008, PAREXEL ConsultingWhere to Look to Learn About FDAs Inspection Procedures For non-biologic GM
15、P and PAI inspections, consult: 7356.002, Drug Manufacturing Inspections, http:/www.fda.gov/ora/cpgm/7356_002/7356-002FINAL.pdf 7346.832, Pre-Approval Inspections/Investigations, http:/www.fda.gov/cder/gmp/PAI-7346832.pdf For GCP inspections 7348.810, Sponsors, Contract Research Organizations and Mo
16、nitors http:/www.fda.gov/ora/compliance_ref/bimo/7348_810/48-810.pdf 7348.811, Clinical Investigators NOTE New as of 12/8/2008 http:/www.fda.gov/ora/ftparea/compliance/48_811.pdf For GLP inspections 7348.808, GLP Inspections (nonclinical laboratories) http:/www.fda.gov/ora/compliance_ref/bimo/7348_808/48-808.pdf 2008, PAREXEL ConsultingWhere to L
