• RF Quarterly

    Current good manufacturing practices and quality system design

    Quality by design, or the principle of building quality into a product and testing, was introduced in 2011 as process validation guidance. Today it is codified within the Title 21 section 820. The quality management system (QMS) encompasses this principle in all areas of healthcare manufacturing – including drugs, biologics, and devices – and, with compliance, can ensure the safety and effectiveness of all manufactured products. The establishment, implementation, and maint...
  • RF Quarterly

    Medical device quality management systems

    Introduction A quality management system (QMS) is one of the five medical device conformity assessment elements. 1 Manufacturers of medical devices are expected to implement, document, and maintain a QMS that “ensures the medical devices it designs, manufactures, and supplies to the market are safe, perform as intended, and comply with the relevant provisions of the regulations in the countries where the product is made available.” 2   Today, a QMS is seen as a ...
  • Feature ArticlesFeature Articles

    MDR, IVDR, and compliance: A guide for distributors

    Distributors must prepare for new incoming requirements under EU medical device and in vitro diagnostic device regulations. The importance of establishing an effective quality management system, drafting comprehensive contractual agreements and, if required, engaging notified bodies, has created much uncertainty for distributors. To fulfil these new requirements and maintain device supply chains, it is essential for distributors to act early, ensure sufficient in-house com...
  • Regulatory NewsRegulatory News

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    WHO Consults on QMS Guideline for Regulators

    The World Health Organization (WHO) in January released for consultation a draft of its upcoming guideline on implementing quality management systems (QMS) for national regulatory authorities (NRAs).   Specifically, the 96-page draft guideline is meant to fill the gaps for NRAs looking to implement a QMS based on the International Organization for Standardization’s (ISO) 9001:2015 Quality Management Systems – Requirements standard, as other existing QMS guidelines do n...
  • Regulatory NewsRegulatory News

    EMA Expands Online Portal for Parallel Distribution Submissions

    The European Medicines Agency (EMA) on Monday announced that going forward, parallel distributors will be required to use its recently launched secure online portal, known as Iris, to manage and submit parallel distribution notifications.   Background   Parallel distribution, also known as re-exportation, is a process by which companies in the EU distribute centrally authorized medicines between member states, independent of their marketing authorization holder (...
  • Regulatory NewsRegulatory News

    Sentinel: FDA Outlines Five-Year Roadmap

    As the US Food and Drug Administration's (FDA) Sentinel Initiative approaches its 11 th anniversary, the agency on Wednesday laid out its vision for enhancing the system over the next five years.   First launched as a pilot program in 2008, the Sentinel Initiative encompasses FDA’s effort to meet obligations set by Congress in the 2007 Food and Drug Administration Amendments Act to develop a system for active postmarket risk identification and analysis for medical p...
  • Regulatory NewsRegulatory News

    FDA Hands Akorn 483 Over GMP Issues at New Jersey Site

    In an inspection report released Friday, the US Food and Drug Administration (FDA) details 11 observations from an inspection of Akorn’s Somerset, New Jersey facility in July and August of this year.   This is the second Form 483 Akorn has received in 2018. In May the company was handed a Form 483 listing a total of 13 observations from an inspection of the company’s Decatur, IL facility, the third inspection report issued for that facility in three years.   Form ...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    FDA Updates Orange Book With Patent Submission Dates

    As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine the earliest date when they may be able to market new generics. FDA began collecting the patent submission date data in 2013, and the agency says there are about 4,000 patent records for which submission dates are available. The update is the result of a final rule fr...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Introduces Tougher Regulations on Homeopathic Medicines (20 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australian Generic Medicine Work-Sharing Trial Misses Completion Target A work-sharing group involving Australian regulators has reported the results of its first collaborative assessment of a generic medicine. The review of the filing took about nine months, four months longer than the collaborators had targeted at the start of the project. Officials from Australia’...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Strengthens Supervision of Online Drug, Device Sales (7 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Strengthens Supervision of Online Drug and Medical Device Sales The China Food and Drug Administration (CFDA) has moved to strengthen oversight of online sales of drugs and medical devices. CFDA outlined its plans in a notice instructing its regional outposts to step up their monitoring of the internet and make it easier for the public to alert them of illegal a...