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The key role of GMP analytical testing for drug products

European Pharmaceutical Review

One of the most significant challenges is keeping up with the changing regulatory requirements set by agencies such as the US FDA, EMA and International Council for Harmonisation (ICH). Additionally, FDA readiness has been established through a proactive external assessment of quality systems. Any identified gaps have been addressed.

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

The FDA Law Blog

Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. All records required under the final rule must be made available to FDA within 24 hours after a request is made. coli contamination.

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What’s next for Container Closure Integrity Testing?

Pharmaceutical Technology

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. Free Webinar. The evolution of CCIT. Wallis and Futuna.

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DSCSA Postponement And What It Means For Independent Pharmacies

DiversifyRx

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. Join our next Awesome Webinar Series with guest legal guru JD from Real Value Rx to answer any questions you have about the DSCSA delay. The DSCSA Adventure continues.

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Marketing Pharma: Proven Strategies to Stay Ahead in a Competitive Industry

Pharma Marketing Network

Stay updated with regulations from the FDA, EMA, and other governing bodies to avoid costly penalties. Highlight your commitment to eco-friendly practices, from reducing packaging waste to sourcing ethically. Using email, social media, in-person meetings, and webinars to deliver a consistent message across platforms.

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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.