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    cGMP Compliance

    • Clarifications to FDA’s Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical IngredientsJune 29th, 2018

      In 2016, FDA published the Q7 cGMP Guidance for Active Pharmaceutical Ingredients. It outlines best practices for everything from quality management issues, personnel, buildings and facilities, equipment and recordkeeping, to validation, change control, complaints and recalls. While it provides very useful information to stakeholders, in …

    • cGMPs for Combination Products – FDA’s Proposal for Streamlined Mechanisms of ComplianceJune 27th, 2018

      On January 22, 2013, FDA published its final rule on cGMP requirements for combination products under 21 CFR Part 4. Specifically Part 4.4 provides two mechanisms for combination product manufacturers to comply with the cGMP requirements: either by complying with all the cGMP requirements of …

    • The Mutual Recognition Agreement Rolls Along – But Where is Germany?June 22nd, 2018

      Earlier this month the FDA recognized the drug inspectorates of Ireland and Lithuania for purposes of the Mutual Recognition Agreement (MRA), and in March of this year, the agency recognized the drug inspectorates of Greece, Hungary, the Czech Republic and Romania. Indeed, it was last October …

    • Does FDA Need Statutorily Imposed Incentives for Regulatory Compliance Matters?April 17th, 2018

      Last year, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA) to revise and extend the user fee programs for drugs, medical devices and biosimilar biological products. Section 902 of FDARA requires FDA to publicly report, annually, information related to inspections …

    • Agency Publishes Final Guidance on Data Integrity – the British Medicines and Healthcare Products Regulatory Agency that isApril 9th, 2018

      It has been two years since FDA published its draft guidance on Data Integrity and Compliance with cGMP, with much fanfare and some legitimate criticism from stakeholders, particularly criticism regarding some overarching assertions that the agency made that are difficult to justify on the basis …

    • “Mutual Recognition” Kicks Into High GearNovember 1st, 2017

      On October 31st, FDA made its long anticipated announcement recognizing the first European drug regulatory authorities capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight countries that were announced are: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. The …

    • Another Brick in the Wall: A New Commitment Implementing the Mutual Recognition of InspectionsAugust 24th, 2017

      According to a European Medicines Agency (EMA) press release issued on August 23, 2017, the FDA, the European Commission (EC), and the European Medicines Agency (EMA) recently signed a new confidentiality commitment that allows the FDA to share non-public and commercially confidential information, including trade …

    • Word to the Wise (Drug Manufacturer): Don’t Use Your Manufacturing Equipment to Produce Toxic, Non-Pharmaceutical ProductsAugust 8th, 2017

      This was FDA’s recent admonition to ChemRite CoPac, Inc. (ChemRite), in a Warning Letter issued on June 29, 2017. Apparently the manufacturer of several over-the-counter oral rinses and oral moisturizing drug products uses the same equipment to manufacture numerous non-pharmaceutical materials, including an industrial car …

    • cGMP Problems Shrink the DepoCyt Chemotherapy MarketJuly 13th, 2017

      In late June, Pacira Pharmaceuticals informed the FDA, the European Medicines Agency, and Health Canada that the company had filed a notice with the U.S. Securities and Exchange Commission, advising of its intent to discontinue all future production of DepoCyt® due to “…persistent technical issues …

    • Batch Manufacturing or Continuous Manufacturing? – That is the QuestionJuly 6th, 2017

      On June 23, 2017 FDA published a notice in the Federal Register entitled: “Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket”. This notice relates to a workshop FDA hosted on …

    • Field Alert Reports – FDA Introduces the Automated Form 3331aJune 25th, 2017

      Earlier this year, we blogged about FDA’s Field Alert Report (or FARs) reporting requirements under 505(k) of the Federal Food, Drug, and Cosmetic Act. The requirements have been in effect since 1985, when the agency promulgated the regulatory provision at 21 CFR 314.81(b)(i). At the time …

    • Brave New World: The Mutual Recognition of CGMP InspectionsMarch 5th, 2017

      Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see here and here) amends the Pharmaceutical Annex to the 1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and …

    • Field Alert Reports – A Brief OverviewFebruary 14th, 2017

      FDA’s Field Alert Report (or FARs) reporting requirements are authorized under 505(k) of the Federal Food, Drug, and Cosmetic Act. The requirements have been in effect since the agency promulgated the regulatory provision at 21 CFR 314.81(b)(i) in 1985. The regulatory provision states, in part, …

    • FDA Issues Final Quality Agreement GuidanceNovember 27th, 2016

      By Jay W. Cormier – After three years of considering public comments on the draft, in last Wednesday's Federal Register, FDA issued its final FDA Guidance for Industry regarding Contract Manufacturing Arrangements for Drugs: Quality Agreements. With this Final Guidance, FDA has clarified its scope, specifically with …

    • Assessing the FDA’s Safety DriveAugust 10th, 2016

      By Mark I. Schwartz* – On March 2, 2015, investigators from the U.S. Food and Drug Administration walked into a factory at Zhejiang Hisun Pharmaceutical in China to conduct an inspection. According to the investigators, at one point a lab employee pulled a memory stick from …

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