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FDA Compliance Case Study
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VQL is a GMP Compliance Auditor, Pharmaceutical GMP Consultant with world-class expertise in pharmaceutical GMP compliance audits and assessment, FDA performance audits, new drug and device approval, RX and OTC drug manufacturing
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This KKAI associate was employed by the US Food and Drug Administration for over 36 years with the principle activity as a Field/Headquarters Investigator evaluating Pharmaceutical and Device manufacturing compliance with cGMPs. Evaluation included compliance deviations and the corrective actions taken to bring operations into compliance with the appropriate provisions of the U.S. Food and Drug Act. This has afforded both the regulatory viewpoint and pharmaceutical manufacturers' viewpoint, resulting in the ability to understand both parties’ obligations.
An American Pharmaceutical Manufacturer of a finished dose form wished to assure that the supplier of the Active Pharmaceutical Agent (API) would, (when visited by FDA) pass their Inspection and could be considered a reliable supplier of the drug ingredient.
The task required visiting Romania, the foreign supplier of the active ingredient to evaluate their GMP compliance status. During a 5-day on-site evaluation of the facilities and their QC practices, numerous deficiencies were observed in the record keeping practices, and the absence of SOP’s in critical areas.
Senior Quality Control and Manufacturing Personnel were provided with specific guidance as to how to remedy the noted deficiencies. At the conclusion of the assessment of their procedures and practices they were advised that their current status would result in a disapproval of the facility.
As a visit by a FDA Investigator was expected to occur within a very short time frame it was agreed that as they prepared corrective documents, SOPS’ on all relevant subjects, this KKAI associate agreed to review for completeness/accuracy and recommend changes as needed.
The work progressed; documents were prepared, reviewed, corrections made and the subject finalized. A number of necessary but less significant changes remained pending that would not be prepared prior to the FDA visit.
The firm requested that this KKAI associate return to Romania to accompany the FDA Investigator on his evaluation of the facility. It was suggested to the firm’s management, that an outline of uncompleted activities be completed with specified target dates for completion.
This document demonstrated to the FDA Investigator that efforts were on-going to address less critical items and in fact, when the newly minted more critical items were reviewed by the Investigator it provided some degree of assurance that the designated tasks would be completed.
The FDA audit concluded with no adverse observations by the investigator and no FD 483 was issued, (the document utilized by the Agency to note adverse findings). The Romanian company was “approved” as a supplier of the API to the American drug Manufacturer.
This case study illustrates the prudence on the part of the American Pharmaceutical Manufacturer to evaluate his supplier and to the API manufacturer who having undergone an FDA audit could assure other customers or potential customers of its level of compliance to cGMPs and the acceptability of its product.
| GMP Compliance Auditor, Pharmaceutical GMP Consultant, pharmaceutical GMP compliance audits and assessment, FDA performance audits, new drug and device approval, RX and OTC drug manufacturing | |
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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
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