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    FDA issues final guidance on CMC postapproval changes for biologics

    The US Food and Drug Administration (FDA) on Monday issued a final guidance to assist manufacturers of biological products in determining which types of changes to their products should be submitted in an annual report and which will require a prior approval supplement, the highest reporting category.   The guidance contains minor changes from a draft issued in December 2017; no reporting changes were switched from the minor to major category. Licensed biological produ...
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    Legislators blast Emergent officials at House hearing

    Members of the US House of Representatives lambasted officials of Emergent BioSolutions for ignoring serious potential contamination and cleanliness problems at their facility, causing millions of COVID-19 vaccine doses to be thrown out.   The House Select Subcommittee on the Coronavirus Crisis, chaired by Rep. James Clyburn (D-SC) along with the House Committee on Oversight and Reform heard testimony from Robert Kramer, president and chief executive officer of Emerge...
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    FDA finds mess of sterility problems at Emergent

    Officials from the US Food and Drug Administration (FDA) urged Emergent BioSolutions to stop producing vaccines until it corrects a litany of unsafe practices at the plant which compromised the quality of products. These problems were identified following a recent inspection of the plant’s facility in Baltimore.   The company was contracted by Johnson & Johnson to manufacture its COVID-19 vaccine but had to throw out 15 million doses recently due to a mix-up of ingredi...
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    China’s new PAC regulation: Closer alignment with global best practices

    This article is a summarized translation of the most recent regulation published by China’s National Medical Products Administration (NMPA) on postapproval changes (PACs). The author provides an overview of the regulation and its annexes for PACs and discusses their impact on manufacturing site change management, change classification determination and consultation, and reporting categories.   Introduction On 13 January 2020, the NMPA published an announcement on t...
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    An overview of upstream manufacturing process and process controls for biologics drug substance: A cytokine case

    This article provides an overview for writing up the biological drug substance manufacturing process and process controls. The authors provide an example for the manufacturing of biological drugs consisting of a cytokine. They cover several complex manufacturing steps and details expected to be included in Section 3.2.S.2.2 (Description of Manufacturing Process and Process Controls) of the Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Us...
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    Designing a biologics manufacturing facility: Early planning for success

    This article reviews important steps in the manufacture of biologics. The authors provide planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC). They pose important questions manufacturers should address, from facility issues to working with a contract development manufacturing organization. They conclude that trends toward reducing the time to market put considerable stress on all aspect...
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    Safeguarding the US Pharmaceutical Supply: Woodcock Discusses Challenges, Shift Overseas

    As drug and active pharmaceutical ingredient (API) manufacturing moves overseas to cut costs, quality and reliability concerns have been raised and the House Energy & Commerce Committee’s Subcommittee on Health met Wednesday to discuss the supply chain with one of the US Food and Drug Administration’s top officials and other experts. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained how part of the problem is that FDA does not know the...
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    FDA Floats Idea of a Rating System for Drug Manufacturers

    The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages supports the idea of creating a new rating system to help drug purchasers, including consumers, better understand the quality management of drug manufacturing facilities. “This idea envisions that pharmaceutical companies could, at their discretion, disclose the rating of the facilities where their drugs are manufactured,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, w...
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    Submitting Manufacturing Facility Information: Final FDA Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized a question and answer guidance on the type of manufacturing facility information that should be included in applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. FDA explains that the guidance is meant to help companies understand how not to submit extraneous information or misplaced or missing information that could result in delays, Refu...
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    PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use. PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, whi...
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    Power Failures Land India-Based Cancer API Manufacturer a Form 483

    Following a five-day inspection last month, the US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Shilpa Medicare Limited after the agency uncovered long-lasting power failures at the site. “During the walkthrough on 24 July 2019, three power failures occurred within the facility during a 15-minute interval and a back-up generator did not resume power,” FDA investigator Yvins Dezan wrote. And while reviewing aud...
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    OPQ Reports on State of Drug Quality in FY2018

    In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...