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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    The World Health Organization (WHO) recently issued a revised draft guidance to industry addressing good manufacturing practices (GMPs) for investigational drug products as well a new draft guideline addressing GMP principles for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   The draft guidance on GMPs for investigational products was prompted by WHO’s Prequalification Team Inspections Services (PQT), which last year expressed the need...
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    Notified bodies report success — and some drawbacks — using remote audits

    Remote audits conducted by notified bodies have been successful in ensuring that medical device manufacturers are complying with the EU’s Medical Device Regulation and In Vitro Diagnostics Regulation, according to a recently conducted survey  of 46 notified bodies, with remote audits uncovering roughly the same number of deficiencies as onsite audits.   The survey was conducted by the European Association of Medical Device Notified Bodies (TEAM NB), located in Liège...
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    Antifreeze and APIs don't mix, FDA tells Syntec

    The US Food and Drug Administration has warned New York-based pharmaceutical manufacturer Syntec for a litany of good manufacturing practice (GMP) problems. The agency says that issues related to how the firm handles active pharmaceutical ingredients (API) compromise the safety of the drugs produced at the site.   Among the problems found by FDA at the firm’s site in Farmingdale, NY, were inadequate contamination safeguards, as well as lax cleaning and testing proced...
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    Updated: FDA grants industry 30-day extension to comment on track and trace guidance

    Editor's note: This story has been updated to include the US Food and Drug Administration's notice extending the deadline to comment on its track and trace guidance. The US Food and Drug Administration (FDA) has agreed to give the pharmaceutical industry more time to comment on a draft guidance calling for the establishment of electronic systems to track products through the supply chain. Prior to Monday's announcement of the extension, two groups representing phar...
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    FDA to Amazon: Stop shipping products that contain undisclosed drugs

    The mammoth online retailer Amazon received an untitled letter from The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) identifying 26 sexual enhancement and weight loss products that contain “undeclared” and “potentially harmful” drug ingredients, according to FDA’s testing of the products.   In this letter — not the first correspondence the agency has had with Amazon on the matter —the firm was called out for marketing unapprove...
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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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    USP, NIST and NIIMBL collaborate to boost viral vector quality standards

    A new public-private collaborative among the United States Pharmacopeia (USP), the US Department of Commerce’s National Institute of Standards and Technology (NIST) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) pools the expertise or the organizations to develop better measurement tools to assess the quality of adeno-associated virus (AAV), an increasingly important vector for gene therapy delivery.   According to a 27 June ann...
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    ICH releases widely anticipated guidance on continuous manufacturing

    The International Council for Harmonisation (ICH) on Tuesday issued its Q13 guideline on continuous manufacturing, making a draft available for public comment.   The long-awaited draft was soon expected, according to an FDA official who gave an update on the status of the guideline at a 14 July CMC Strategy Forum sponsored by the California Separation Science Society (CASSS). (RELATED: Long-awaited ICH continuous manufacturing guideline coming soon , Regulatory Foc...
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    FDA’s revised MAPP outlines procedures for generic drug labeling changes

    The US Food and Drug Administration’s (FDA’s) Office of Generic Drugs recently issued a revised Manual of Policies and Procedures (MAPP) describing the agency’s internal procedures for handling generic drug labeling changes, including listing the responsibilities of the internal FDA staff responsible for managing these labeling changes.   The 16-page MAPP implements Section 10609 the Patient Protection and Affordable Care Act (PPACA) which was enacted in 2010 and add...
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    FDA declines to extend nitrosamine risk assessment deadline

    The US Food and Drug Administration (FDA) rejected pleas from the pharmaceutical industry to extend the deadline for conducting nitrosamine risk assessments to 1 September, standing firm on the 31 March deadline.   Industry representatives also told FDA to align its guidance with the International Council on Harmonization’s M7 guidance on impurity testing, saying  that divergent expectations have “created many challaneges for the pharmaceutical industry and increased ...
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    EMA adopts guideline on quality documentation for drug-device combination products

    The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA).   It also incorporates the recent revision of the EU’s Medical Devices Regulations (MDR) in requiring makers of these products to obtain the results of conformity testing of the device part from a notified body. The MDR regulation went into effect in May 2021. (RELATED: EMA Kicks...
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    FDA finalizes guidance on field alert reports

    The US Food and Drug Administration on Thursday finalized guidance on its expectations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in submitting field alert reports (FARs) for potentially defective drugs. It contains only minor changes from the draft.   The final document supersedes a draft guidance that was issued in July 2018. (RELATED: Field Alert Report Submissions: FDA Offers Draft Q&A , Regulatory Focus 19 Jul...