• Regulatory NewsRegulatory News

    Mylan Pharmaceuticals Pledges to Resolve FDA Citations Over Quality Control Failures

    Following the 13 nonconformities that were revealed during a US Food and Drug Administration (FDA) inspection of a Mylan Pharmaceuticals manufacturing site, Focus obtained a copy of the company’s response to the agency via a Freedom of Information Act (FOIA) request. The response to the 31-page Form 483, which was issued after the FDA visit to the plant in Morgantown, WV earlier this year, outlines a total of 77 commitments to address the inspectional observations....
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    CDRH Looks to Expand Case for Quality Program

    With plans to establish a full program next year, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) recently met its goal to complete at least 30 appraisals under the voluntary case for quality (CfQ) pilot program by year’s end. CDRH had already completed a total of 35 appraisals across 18 device companies, as of earlier this month, in collaboration with the Medical Device Innovation Consortium (MDIC) and the CMMI Institut...
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    Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight. Background In recent years, FDA has worked to update its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths and new requirements brought on by the Drug Quality and Security Act (DQSA) of 201...
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    FDA Details New Manufacturing Quality Pilot Program

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last month released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative. "CDRH envisions a future state where the medical device ecosystem is inherently focused on device features and manufacturing practices that have the greatest impact on product quality and patient safety," FDA write...
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    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
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    MDSAP Changes Aim to Reduce Audit Times

    With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits. The changes follow comments received by Health Canada from Canadian medical device license holders regarding the current audit-time model for MDSAP and subsequent annual survei...
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    UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments

    Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopeial standards for biologics, according to a report issued Monday. In general, MHRA says the responses supported the value of standardization, and found that areas where standards could add value included providing guidance and ensuring consistency for product characterizat...
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    Mistake-Proofing the Workplace

    This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors. Introduction On his first job working for a large pharmaceutical company, one of the authors, Max Sherman, was responsible for th...
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    CDRH to Launch 'Critical to Quality' Pilot Program

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will lead a pilot program to define characteristics of a device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection. The voluntary pilot, which will run from 29 September to 31 December 2018, invites firms submitting a Premarket Approval Application (PMA) to consider participating ...
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    EMA Updates Guidance on Three Post-Authorisation Activities

    The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations. "The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes," EMA writes. Specifically, the updates include a new pre-submission c...
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    Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions

    This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan. Introduction From clinical trials to marketing authorization, regulatory dossiers for small molecule drug products are incomplete without the presentation of certain regulatory certif...
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    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...