• Regulatory NewsRegulatory News

    European Commission Consults on Revised GMPs for Sterile Drugs

    The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4 . The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times si...
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    UK's MHRA: Apotex Site Does Not Comply With GMP Requirements

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant. A statement of non-compliance with good manufacturing practice (GMP) requirements highlighted the site’s non-complaint operations related to non-sterile products, packaging and quality control testing. "Due to the nature of the issues identified, batches not released to market are included in the ...
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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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    How to Conduct Data Integrity Investigation Interviews

    Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel. Introdu...
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    Asia Regulatory Roundup: CFDA Maps Out Regulatory Transparency (28 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Prepares for Joint National-State Inspections of Manufacturing Plants India has laid the groundwork for joint inspections of drug manufacturing plants by officials from national and state regulatory agencies. Officials will conduct joint inspections whenever a facility seeks a license to make or sell drugs and at risk-determined intervals to check ongoing compli...
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    Lupin Warned by FDA for Deficiencies at Two Facilities

    The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India. Lupin acknowledged receiving the warning letter in a Bombay Stock Exchange filing on 7 November, saying it had responded to nine observations stemming from FDA's inspections and that it will work to address the concerns raised in the warning letter. The warning letter says Lupi...
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    FDA to Recognize 8 EU Regulators to Conduct GMP Inspections

    The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The announcement follows the creation of a mutual recognition agreement between the US and EU last March as part of a more collaborative approach to drug ma...
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    Updated FDA Manual Offers Inside Look at Inspection Protocols

    The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect. The 127-page chapter offers the basics for how FDA inspectors should go about conducting what it calls, a "careful, critical, official examination of a facility to determine its compliance with laws administe...
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    FDA Warns Korean Drugmaker Over Testing, GMP Issues

    The US Food and Drug Administration (FDA) has warned South Korean drugmaker Dasan E&T Co. Ltd. over product testing issues following an inspection of its Gimpo, Kyonggi-do facility in January. In a warning letter released on Monday, FDA says the company failed to adequately test its raw materials and finished products to ensure they conformed to appropriate specifications. "Your firm failed to analyze glycerin raw material from your supplier prior to the quality unit re...
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    FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors

    The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May. According to FDA, the firm's management admitted to falsifying analytical test results used to release a lot of its products to the US. In another instance, FDA says the firm reported that a batch of one of its products was within specification ...
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    Asia Regulatory Roundup: Drugmakers Push Back on Data Requirements in Australia’s Provisional Approval Pathway (5 September 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Big Drugmakers Push Back Against Quality Data Requirements in TGA Provisional Approval Plan A who’s who of leading drugmakers have raised concerns about the proposed data requirements for Australia's provisional approval pathway. The concerns center on the potential for the need to provide months of stability data and achieve good manufacturing practice (GMP) clearance...
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    FDA Details Plans for More Efficient Inspections, Facility Evaluations

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts. In an email to FDA staff on Monday, CDER Director Janet Woodcock and Associate Commissioner for Regulatory Affairs Melinda Plaisier said it is vital that the two offices quickly implement the plan in order to meet commitments under the recent...