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WHAT TO DO WHEN THE FDA KNOCKS AT YOUR COMPOUNDING PHARMACY DOOR!
First, don’t panic! Have a Plan. The Plan should be written, maintained in a binder and located for easy access by responsible personnel. The Plan should be used for training all affected personnel and include the following:
1) The identity (name, phone number, location at site) of a person assigned responsibility to initially meet and accompany the FDA Inspector. The FDA Inspector will initially request an opening meeting with the CEO and if not on site, the next senior management official responsible for operation of the site. During this initial meeting the FDA Inspector is required to display their credentials, FDA issued badge and identity card, and issue a Notice of Inspection, form FD-482, to the senior management official currently on site prior to initiating the inspection. The identified site person should be able to quickly determine who the senior management official is on site. There should be a list of senior management officials, name, phone number, location on site, included in the Plan. There should be no delay in locating the senior management official for the FDA Inspector. A delay in locating the senior management official could be viewed by the FDA Inspector, as an intentional delay in access to the facility, to allow site personnel to cover up known CGMP problems. The initial contact with the FDA Inspector can set the tone for the entire inspection. Thus, it is very important the Plan be rehearsed for quick identification of senior management at the site.
2) A location, office or conference room for FDA Inspector use during the inspection should be identified.
3) Identity of personnel responsible for:
identified in the Draft FDA CGMP Interim Guidance for Human Drug Compounding Outsourcing
Facilities, July 2014
required since personnel may not be present during the FDA Inspection due to vacations, illness or
4) All personnel should be trained in the Plan and also in their assigned duties. Rehearsing of all personnel should be performed especially for personnel likely to be interviewed by FDA concerning Quality Systems. Personnel should be trained only to answer FDA questions in their area of expertise. FDA Inspectors expect to hear the correct answer to posed questions since incorrect answers could be viewed as misleading. If an SME or any other employee cannot answer an FDA Inspector Question, the correct answer should be “I do not know the answer to the question and will locate the correct person to answer the question.”
5) Assignment of personnel to be present for the FDA Inspection closeout and issuance of form, List of Observations, FDA483. The FDA Inspector is required to issue the FDA483 to the senior management onsite. Usually the same individual issued the Notice of Inspection, FD-482. Personnel should be assigned for responding to CGMP observations listed on the FDA483. The personnel assigned could be the SMEs assigned for each of the Quality Systems. The site should plan on responding within 15 business days from the date of issuance of the FDA483. The response should include a narrative description of an investigation, root cause and corrective action for each FDA observation. Supporting documentation should also be provided. The response should also include a commitment to perform a global assessment of all Quality Systems utilized at the site with follow-up corrections, if warranted, to be provided to FDA.
About the Author:
Mr. James Evans, Senior Consultant for EAS Consulting Group, LLC, works for clients in a variety of areas in the pharmaceutical, compounding pharmacy, medical device, biologic and biotechnology fields. With his more than 30 years of experience auditing at the FDA, he is well versed in pharmaceutical inspections, antibiotics, radiopharmaceuticals, parenterals, sterilization, clinical/non-clinical (GLP) laboratory studies, and computer systems validation and pharmacology. He conducts mock FDA inspections as well as GMP inspections of drug and biologic products as well as assists with audit preparations of Clinical Investigators, Institutional Review Boards and Bioequivalency testing. Mr. Evans also works internationally with foreign Biologic, Biotechnology, Pharmaceutical and Medical Device product manufacturers.
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