Featured Pharma Online Editorial
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Key Post-Pandemic Trends In Global FDA Observations For Drug Facilities
6/29/2023
These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities.
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ICH Q12 Post-Approval Change Management Protocol
6/27/2023
The ICH Q12 guideline includes information about the post-approval change management protocol, which aims to simplify the process of registering site changes under certain criteria through an emphasis on gaining accelerated up-front feedback from the regulator before compiling submissions. Following this protocol reduces the approval cycle by up to six months.
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Agile Software Development In Bio/Pharma & Medical Devices, Part 1
6/27/2023
Under the FDA and other regulatory bodies, the bio/pharma and medical device industries have been using computer software/systems validation testing methodologies to validate software within the GxP environment. Let's dive into the use of Agile methodology in the planning phase of a software development plan.
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The Digital Future Of CMC Regulatory Affairs
6/23/2023
This article discusses recent initiatives from the FDA, such as KASA, PQ/CMC, and the ICH SPQS. Let's look at how they could be the early birds of the paradigm shift from electronic CTDs to digital CTDs. The article also addresses what steps the industry should be taking in parallel with the authorities in preparation for this (very near) digital future.
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Navigating Regulatory Guidelines For Effective Tech Transfer
6/22/2023
The authors discusses important aspects of tech transfer (the project management plan, gap analysis, risk assessment, and more) and share the notable FDA and WHO guidelines related to each area.
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An Agile Approach To Regulatory Information Management System Transformation
6/20/2023
Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically.
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FDA Seeks Input On AI Adoption In Drug Development And Manufacture
6/13/2023
The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.
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The Business Case for Healthcare Compliance Programs for Emerging Companies
6/9/2023
For emerging drug and medical device companies on a tight budget, an effective healthcare compliance program can actually save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in pre-commercial stages and will prepare you for the regulated future ahead.
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Breeze Through Surprise Audits — Take These 5 Actions Now
6/8/2023
Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.
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All You Need To Know About Contamination Control Strategies, Part 2
5/22/2023
In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.