The Center for Drug Evaluation and Research (CDER) has recently launched two (2) quality management pilot programs for Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs). The purpose of the pilot programs is to gain insight from the third-party assessments of the manufacturer’s quality management system (QMS) and enhance the future devel
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November 19, 2020 Compliance, Audit and Validation, Regulatory Affairs -
September 30, 2020 Compliance, Audit and Validation, Regulatory AffairsTo support manufacturers during COVID-19, the EMA has updated guidance on the Regulatory expectations for the medicinal products. A new section of temporary flexibilities is added to inputs on good manufacturing practices (GMP), and good distribution practices (GDP). The new development is aimed at responding to the increased demand for medicinal products amid COVID-19.
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January 30, 2020 Regulatory AffairsThanks to the evolving global Regulatory landscape! Each country now has its own, defined regulations and requirements in governing the quality, safety, and efficacy of the medicinal products entering or being manufactured in their market. In this scenario, it is necessary for organizations to know about specific Regulatory requirements of their targeted markets.
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November 29, 2019 Cosmetics Regulatory Services, Regulatory AffairsCosmetic products are one of the most widely used category of personal care products across the globe. Hence, they should be manufactured in a safe and effective manner. To ensure the same, Health Authorities across the world have established certain Good Manufacturing Practices (GMP).
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August 12, 2019 Compliance, Audit and Validation, Regulatory AffairsDo you know? To rely on each other’s Good Manufacturing Practice (GMP) inspections pertaining to human medicines, the European Union (EU) and the United States (US) have signed a Mutual Recognition Agreement (MRA) in 1998. However, despite a series of actions and progressive discussions, it was never operational. But the talks which began in 2014 led to revision of Annex in 2017.
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June 25, 2019 Medical Devices, Compliance, Audit and Validation, Publishing & SubmissionsIn December 2018, the United States Food and Drug Administration (US FDA) published the final guidance on Manufacturing Site Change Supplements: Content and Submission. Replacing the 2015 draft guidance, the final guidance clarifies the responsibilities of medical device manufacturers who are willing to change their manufacturing site for an approved device.
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September 25, 2018 Compliance, Audit and Validation, Registration Strategy, Regulatory AffairsOver the decades, with the inception of strict Regulatory regimes, life sciences companies have launched numerous medicinal products in the market prioritizing the end user’s safety. But only few have remained popular sustaining the market competition while many fail to break the initial Regulatory barriers because of incompliant practices.
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November 9, 2017 Compliance, Audit and ValidationBetween 10/1/2015 and 9/30/2016, the United States Food and Drug Administration (USFDA) through its system has issued almost 3905 483s to Biologics (84), Medical Devices (934), Drugs (691), and Food (2196) manufacturers. The number shows that there is significant rise in manufacturing violations when the health agency inspected respective facilities.