A Peer-Reviewed Journal Focused on GMPs and Validation
March 2025

Featured Article

FEATURED BOARD MEMBER
Gaurav Walia
Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner
PQE Group
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The EU AI Act and the New Scenario for a Global AI Regulation: AI from Values to Business Growth from a PQE Group Perspective

Luca Zanotti Fragonara, Advanced Technologies Competence Centre Lead, PQE Group

Gaurav Walia, Principal SME of Computer Systems Validation, Computer Software Assurance and Data Integrity; Sr. Associate Partner, PQE Group

We live in the era of Artificial Intelligence, and we are now familiar with various aspects of it: ChatGPT, Copilot, Avatar, algorithms and many more. Artificial Intelligence has become pervasive in many of the daily processes that businesses engage in (e.g., social media, Research & Development, decision-making, manufacturing, cybersecurity, etc.). Its use and development raise numerous ethical and professional questions.

How does PQE Group use Artificial Intelligence?
PQE Group primarily deals with Artificial Intelligence (AI) in the context of Life Sciences, which includes pharmaceutical companies as well as companies that produce medical devices; both of these industries are highly regulated...

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Industry News
FDA Outsourcing Facility Inspection Guide
FIELD REPORTING REQUIREMENTS:
  1. Establishment Inspection Reports (EIRs) are to be created and filed electronically using the specific module in eNSpect or replacement system that is accessible to both the Office of Inspections and Investigations (OII) and the Center for Drug Evaluation and Research (CDER).
  2. For inspections of Outsourcing Facilities classified as Official Action Indicated (OAI) due to the failure to comply with section 503B of the Food, Drug, & Cosmetic Act (FD&C Act), section 501(a)(2)(A) of the FD&C Act, or the Current Good Manufacturing Practice (CGMP) requirements in section 501(a)(2)(B) of the FD&C Act as established in 21 CFR Parts 210 and 211 as they apply to human drugs, OII divisions should, as soon as practical, report significant inspection issues into eNSpect, as per the Investigations Operations Manual (IOM), and endorse inspections for advisory, administrative, or judicial actions in accordance with the Regulatory Procedures Manual.
  3. The OII Divisions are requested to use this compliance program for all Outsourcing Facility inspections.
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This Month's Dose of Knowledge
March is National Nutrition Month!
As we celebrate National Nutrition Month, it's the perfect time to reflect on how our nutrition impacts our productivity and overall well-being at work. In today's fast-paced professional environment, maintaining high energy levels and sharp focus is essential for success. The food we eat not only fuels our bodies but also influences our mental clarity and performance. With that in mind, here are five invaluable tips designed to help you optimize your nutrition, boost your productivity, and create healthier habits that can lead to more successful outcomes!
Prioritize Balanced Meals: Aim for meals that include a balance of lean proteins, healthy fats, whole grains, and plenty of fruits and vegetables. This combination provides sustained energy and helps maintain focus throughout the day.
Stay Hydrated: Dehydration can lead to fatigue and decreased concentration. Make it a habit to drink plenty of water throughout the day. Keep a refillable water bottle at your desk, and set reminders if necessary. Herbal teas or infused water can also be great alternatives for added flavor.
Mindful Snacking: Choose snacks that fuel your body and brain, such as nuts, yogurt, fruit, or whole grain crackers. Avoid high-sugar or highly processed snacks that can lead to energy crashes. Portion out snacks in advance to help prevent mindless eating during busy work hours.
Plan for Breaks: Schedule short breaks for meals and snacks to recharge both your body and mind. Stepping away from your desk, even briefly, can help you reset and boost productivity. Use this time to enjoy your food mindfully—focus on flavors and textures, which can enhance satisfaction and prevent overeating.
Limit Caffeine Intake: While caffeine can provide a temporary energy boost, over-reliance on coffee or energy drinks can lead to jitters and a crash later on. Try to limit caffeine consumption to moderate levels and consider healthier alternatives, like herbal teas or even afternoon walks, to maintain energy levels.
By incorporating these nutritional tips into your daily routine, you can enhance your overall productivity and well-being while achieving your nutrition goals during National Nutrition Month!
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