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    FDA blasts US API firm for lax response to mold contamination, data integrity failings

    A US manufacturer of active pharmaceutical ingredients (API) was lambasted in a recent warning letter by the US Food and Drug Administration (FDA) for multiple good manufacturing practice (GMP) violations, one of which was a failure to adequately respond to mold contamination.   The firm also failed to maintain control over its computer systems to prevent unauthorized access to electronic data.   The warning letter was issued on 18 July to St. Louis-based manufactu...
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    Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method

    A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to address this issue from a good manufacturing practices (GMP) standpoint, and not a compendial approach as espoused in the US Pharmacopoeia’s (USP) Chapter 790 method.   Stephen Langille, senior microbiology consultant with ValSource, Inc, and a former microbiologist with the ag...
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    FDA warns firm for selling unapproved stem cell products and GMP, GTP deviations

    The US Food and Drug Administration (FDA) on 2 February warned an Idaho-based firm, Smart Surgical, dba Burst Biologics, for marketing and distributing allogeneic stem cell products for unapproved uses and for “significant” deviations from current good manufacturing practice (CGMP) and good tissue practice (CGTP) requirements.   The warning letter, which was posted to FDA’s website this week, follows an inspection conducted one year ago, just months before the agency e...
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    ICMRA: Remote inspections can complement, but not replace, onsite inspections

    While there are benefits to conducting remote good clinical practice (GCP) and good manufacturing practice (GMP) inspections and these assessments can continue being used  post pandemic, these methods have their limitations, concludes the International Coalition of Medicines Regulatory Authorities (ICMRA) in a new reflection paper .   Among the topics ICMRA touches on in the reflection paper are the decision-making process to use remote approaches, tools for remote in...
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    Pharma, device groups oppose FDA's planned drug to device transition

    Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to devices, in implementing a recent court decision. The Association for Accessible Medicines (AAM) says that the agency’s implementation of the order is hasty and has no legal merit, while the Advanced Medical Technology Association (ADVAMED) pointed out that compani...
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    FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires

    Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administration (FDA) to issue three warning letters for good manufacturing practice (GMP) violations to an over the counter drug manufacturer, a finished drug manufacturer and an API manufacturer in the US.   The recipients of the warning letters, w...
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    FDA addresses microbial contamination in non-sterile drugs

    The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to help manufacturers control microbiological contamination of their non-sterile drugs (NSDs). The guidance stems from FDA’s concerns over a high number of adverse events and recalls associated with contaminated products.   The agency reports receiving 197 adverse event reports from microbiological or fungal contamination of non-sterile products between 2014 and 2017. Of these, 32 were deeme...
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    Three foreign OTC firms slapped with warning letters for GMP testing violations

    Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one led the US Food and Drug Administration (FDA) to issue three warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.   The recipients of the warning letters, which were all issued in mid-September, include Laboratorio Pharma International in Tegucigalpa, Honduras, a manufacturer of antibiotics and ...
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    WHO revises guidance on GMPs for investigational products, R&D facilities

    The World Health Organization (WHO) recently issued a revised draft guidance to industry addressing good manufacturing practices (GMPs) for investigational drug products as well a new draft guideline addressing GMP principles for research and development facilities in the context of the COVID-19 pandemic.   The draft guidance on GMPs for investigational products was prompted by WHO’s Prequalification Team Inspections Services (PQT), which last year expressed the need...
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    EMA updates reflection paper on GMP responsibilities of marketing authorization holders

    The European Medicines Agency (EMA) on Thursday issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission (EC) GMP guidelines and other EU legislation.   The paper replaces a draft version issued in January 2020 with only some minor revisions. (RELATED: EMA Consults on GMP Reflection Paper , Regulatory Focus, 22 January 2020).   The paper covers the re...
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    PIC/S updates GMPs for ATMPs, biological substances

    Revisions to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide addressing the manufacturing of advanced therapy medicinal products (ATMPs) as well as biological medicinal substances and products are set to go into effect 1 May.   PIC/S published the final Annex 2A and Annex 2B on 23 April after a consultation that began in September 2019. (RELATED: PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances , Regulatory Focus, ...
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    European Commission Adopts Two Acts on GMPs for Medicines

    Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use. One of the acts is an  implementing directive  that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization ( see Article 40 of the Community code Directive (2001/83/EC) ). The ...