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

Featured Article

FEATURED BOARD MEMBER
Sachin Bhandari

Global Head,
Equipment Qualification
Boehringer Ingelheim International GmbH
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Fit for Intended Purpose- Key Concept in USP General Chapters and ICH Guides

By Jane Weitzel, Quality Control Expert, and USP Council of Experts Member & Chair of the 2020-2025 General Chapters –Measurement and Data Quality

Fit for intended purpose is a key, central concept for USP <1220> Analytical Procedure Life Cycle, ICH Q2(R2) Validation of Analytical Procedures, and ICH Q14 Analytical Procedure Development. The performance criteria for the analytical procedure during its entire life cycle are based on the intended purpose of the reportable results generated by the analytical procedure as shown in Figure 1.

The concept of fit for intended purpose may be new to the pharmaceutical industry; however, it is an established concept in the metrological community. The editorial “ ‘Fitness-for-intended-use’ is an Important Concept” states; “Let us here take a special look at that most important intention we have when we carry out a measurement: the intended use of the result.” ...

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Industry News
FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products
Agency Encourages Public Input on Proposal That Aims to Prevent Millions of Premature Deaths

Nicotine is the primary addictive chemical in tobacco products that keeps people using the products. The proposed rule would not ban cigarettes or any other tobacco products. The FDA is proposing to cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products, which is significantly lower than the average concentration in these products on the market today. Would this impact you personally?
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Know When and How to Use Antibiotics, and When to Skip Them
Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness. They treat only some infections caused by bacteria – and none caused by viruses. Here’s how you can safely use antibiotics so you can get well, protect yourself and your family, and combat antimicrobial resistance.
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Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
Draft Guidance for Industry and Food and Drug Administration Staff
This draft guidance document provides recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA’s evaluation of safety and effectiveness.
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This Month's Dose of Knowledge
Top Tips: Staying Positive and Productive in February
February is here, and as the momentum from January's resolutions begins to wane, it’s a great time to refocus and rekindle your enthusiasm. Here are five tips to help you stay positive and productive this month:
Set Realistic Goals: Reevaluate your resolutions. Break them into smaller, manageable tasks to keep from feeling overwhelmed. Remember, progress is more important than perfection.
Celebrate Small Wins: Acknowledge and celebrate your achievements, no matter how minor they may seem. Each step forward is a triumph that fuels further motivation.
Cultivate a Supportive Environment: Surround yourself with people who encourage and inspire you. Sharing goals and enjoying mutual support can significantly boost your morale and keep you on track.
Embrace Self-Care: Don't forget to take breaks and invest in self-care routines. A well-rested mind and body are more efficient and creative.
Infuse Fun into February: With Valentine’s Day approaching, focus on doing what you love. Whether it's a hobby, spending time with loved ones, or simply enjoying some fun activities, nurturing your passions can be both energizing and rewarding.
As you delve into February, remember to love what you do—and do what you love. Embracing this mindset not only enhances joy but also keeps your goals in clear sight. Here’s to a fulfilling and productive month ahead!
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