David Luftglass’ Post

🔔 Exciting News in Pharma Regulation! 🔔 🌟 Just in: CDSCO unveils new GDP guidelines for pharmaceutical products, ushering in a wave of enhanced quality and safety standards. 💊💼 📚 These guidelines promise to revolutionize the way pharmaceutical companies handle storage, transportation, and distribution, ensuring that every step of the supply chain upholds the highest standards of quality and integrity. 🚛✨ #CDSCO #PharmaRegulation #GDPGuidelines #QualityAssurance #DrugSafety 📝

This is very interesting. I still think it will be very difficult to upset certain markets throughout the US. It does make sense for some of the new markets to source the cannabis at the lowest possible price, but what will the effects be? I am very interested to see how this pans out. #TheFutureofCannabis #Thoughts

“The European Clinical Trial Act of 2014 does not require the pharmaceutical industry to demonstrate that their new medicine represents a therapeutic breakthrough, thus squandering a chance to stimulate comparative assessments of new drugs with existing ones.32 Critics argue that the FDA has lowered its evidence criteria by approving drugs with debatable efficacy, and its decisions in areas of urgent unmet medical need have received particular attention.33, 34 Frequently, manufacturers are granted marketing authorization with insufficient data on clinical benefit. Comparative trials are often absent, or may suffer from various methodological issues, making it difficult or impossible to establish clinical effectiveness.35-38 These are a few reasons why we have many “me too” drugs on the market. These products, whereas not offering additional clinical benefit, may offer important alternative treatment options to patients; however, overproduction of so-called “me too” options diverts important resources from pursuing developments which can make clinically important differences to patients”.

batch manufacturing record is a very essential document & it provides us with the full history of batch manufacturing. We can trace out the personnel involved in the manufacturing of a specific batch. We can trace out which equipment was used during the manufacturing of a specific batch. We can trace out the qualified personnel involved in the manufacturing of a specific batch. We can verify which excipients' lot numbers were used in a specific batch along with their quantities. We can verify which APIs' lot was used for manufacturing. BMR gives us information about real-time or actual data at which the batch was granulated, compressed, coated, filled, or filtered. BMR also contains quality control reports & we can trace out the batch results.

This is very interesting. The warning letter begins with an observation wherein a group of operators manipulates visual inspection results to maintain an acceptable rejection rate. I wonder how and why they develop such motives. #WorkplaceEthics #dataintegrity #culture #quality https://lnkd.in/g2KkFxXw

Dissolution testing according to USP monograph. #dissolution #usp #drugproduct #drugmanufacturing #drugtesting

#pointofcare and distributed #pharmaceutical #manufacturing is a great area where advanced inline process analytical technologies can play an important role in #qualitycontrol and reliability.

Interesting to limit the amount of post-harvest flower, as well as the inclusion of homemade extract limits, the very existence of which seems to permit/acknowledge home extraction.