Week of June 10th 2018 | FDA Sent This Warning Letter to a Pharma Company

A slow warning letter week, 3 from the Center for Tobacco Products and 1 issued to a pharma manufacturer that we address below:

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  • Taiwan Biotech Company Ltd (Taiwan R.O.C.) received a warning letter dated May 31st 2018 based on the outcome of an inspection ending on September 11th 2017. The firm manufactures over-the-counter drug products. FDA suggests the firm contract with a consultant to assist them in coming into GMP compliance. They also say that the Quality Unit is ‘not able to fully able to exercise its authority and/or responsibilities.’ FDA suggests that the Q unit does not have appropriate authority or sufficient resources. Deficiencies include but are not limited to:
    • EM results that exceeded action limits were not investigated, including those from the ISO 5 areas. This included one with a value of 140 CFUs in the ISO 5 area.
    • The firm reported there were no values outside of limits for more than a year before the inspection. Difficult to believe because there were numerous samples that had significant growth that had not been enumerated or investigated. FDA says that failure to “…fully investigate the systemic flaws that led to the unreported data raises questions regarding the integrity of data generated by your firm.”
    • The investigator determined that surface samples had not been collected since September 1st 2017.
    • To address the problems in the area of environmental monitoring, FDA asks the firm to provide:
      • “Further details on additional microbiological plates that were not initially enumerated and the results that your firm ultimately obtained for these plates. Also, summarize all lots made without sufficient environmental monitoring on the (b)(4) and (b)(4). Provide risk assessments for any potentially affected products marketed to the United States.
      • Your investigations of multiple deviations from action limits for ISO 5 and other clean areas.
      • A thorough, independent assessment with corrective actions and preventive actions (CAPA) for your environmental monitoring and personnel monitoring programs. For instance, your remediation should include adequate sampling procedures, media suitability, sample accountability (e.g., identification, storage, logging, analysis dates/times), appropriate locations and frequencies, proper responses to alert and action limits, routine identification of microbes isolated from cleanroom and personnel samples, and various other elements of an effective program.
      • A comprehensive, independent review of your laboratory practices, methods, equipment, and analyst competencies. Based on this review, provide a detailed CAPA plan to fully remediate your laboratory system. Your plan should also include the process you will use to evaluate the effectiveness of the implemented CAPA.
      • A comprehensive identification of all contamination hazards in your aseptic processes, equipment, and facilities. Provide an independent risk assessment that covers, among other things, all human interactions with the ISO 5 area, equipment placement and ergonomics, air quality in the ISO 5 area and surrounding room, facility layout, personnel flow, and material flow.”
    • The firm failed to follow their stability program; testing intervals were missed or late. FDA requests they provide:
      • A retrospective review into all missing or delayed stability testing that is intended to support the shelf-life of each of your U.S. products.
      • An impact assessment for the missed or delayed stability testing, and an updated summary of all stability data (i.e., data obtained for each testing) supporting each of your U.S. products.
      • A comprehensive assessment and CAPA to ensure the adequacy of your stability program. Your CAPA should include, but should not be limited to, correcting the root causes of the missed and delayed stations, ensuring adequate number of qualified quality control personnel, improved procedures, and comprehensive personnel training.”
    • The firm’s annual product reviews consider only products shipped to the US, not all lots manufactured under the same conditions.
      • “In response to this letter, provide an assessment of manufacturing and quality data associated with each drug marketed to the United States. Include remediated procedures and retrospective trending to identify any adverse findings and determine the need for changes to manufacturing, control, or specifications.”
    • The FDA also included the short version of the data integrity remediation boilerplate that the firm must address.

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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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