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Joe Franchetti, CEO and Managing Consultant here at JAF Consulting, presents a Warning Letter Review at the 4th Annual Spring Pharma Conference at East Carolina University.

In it, Joe reviews the #483s issued from the Systems Inspections ending between October 1, 2021 and September 30th, 2022 (61 Biologics, 126 Bioresearch Monitoring, 538 Devices, 466 Drugs, 2399 Foods, 81 Human Tissue for Transplantation, 23 Parts 1240 and 1250, 9 Radiologic Health, 184 Veterinary Medicine) amongst other things. Like the Top 5-Year Cumulative Trending cGMP FDS Inspectional Observations:

  • 21 CFR 211.110(a) — To assure batch uniformity and integrity of drug products, written
    procedures shall be established and followed that describe the in-process controls, and tests, or
    examinations to be conducted on appropriate samples of in-process materials of each batch. Such
    control procedures shall be established to monitor the output and to validate the performance of
    those manufacturing processes that may be responsible for causing variability in the characteristics of
    in-process material and the drug product…
  • 21 CFR 211.67(a) — Equipment and utensils shall be cleaned, maintained, and, as appropriate for
    the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or
    contamination that would alter the safety, identity, strength, quality, or purity of the drug product
    beyond the official or other established requirements.
  • 21 CFR 211.68(b) — Appropriate controls shall be exercised over computer or related systems to
    assure that changes in master production and control records or other records are instituted only by
    authorized personnel.
  • 21 CFR 211.25(a) — Each person engaged in the manufacture, processing, packing, or holding of a
    drug product shall have education, training, and experience, or any combination thereof, to enable that
    person to perform the assigned functions.
  • 21 CFR 211.67(b)— Written procedures shall be established and followed for cleaning and
    maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding
    of a drug product.
  • 21 CFR 211.166(a) — There shall be a written testing program designed to assess the stability
    characteristics of drug products. The results of such stability testing shall be used in determining
    appropriate storage conditions and expiration dates.
  • 21 CFR 211.100(a) — There shall be written procedures for production and process control
    designed to assure that the drug products have the identity, strength, quality, and purity they purport or
    are represented to possess.
  • 21 CFR 211.160(b) — Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures.
  • 21 CFR 211.192 — Production record review – Investigations of discrepancies, failures.
  • 21 CFR 211.22(d) — The responsibilities and procedures applicable to the quality control unit shall
    be in writing; such written procedures shall be followed.

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