Industry support of overdose prevention This is blog 8 of 10 Blogs in the overdose awareness and overdose prevention series. What is GxP compliance? And how does GMP/GxP compliance help with overdose prevention efforts? Compliance with manufacturing regulations (GMP/GxP guidelines): Accurate packaging and labelling information can help: Download the latest Australian overdose statistics report (2021)…
Snapshot of the Opioid Crisis (Legal Cases) This is blog 6 of 10 blogs in the overdose awareness and overdose prevention series. International Overdose Awareness Day (31st August) is rapidly approaching. It warrants a discussion of the opioid crisis in the United States, a 20-year phenomenon where over 800,000 people have lost their lives to…
FDA Crackdowns on False Claims for Medicinal Cannabis Products False Claims, Fake Medicines and Counterfeit News – Why the U.S. FDA is cracking down on cannabis-product advertising claims and unsubstantiated efficacy statements. Are U.S. medicinal cannabis suppliers preying on vulnerable populations with deceptive ads? The FDA is taking stronger actions to reduce deceptive advertising practices…
Fake medicines and substandard supplements are increasingly being distributed and consumed across the globe. This is partially due to thousands of unauthorised online pharmacies selling substandard medications, counterfeited pharmaceuticals and other fake drugs. It’s also partially related to consumers having a discount mentality, even when it means they’re putting their lives at risk. With further…
Counterfeit medicines — fake drugs and falsified medicines — are endangering lives. How large is the problem of substandard medications and falsified pharmaceuticals? What are the global statistics of counterfeit medications entering countries across the globe? And how many fake medicines are entering Australia’s pharmaceutical supply chains? Once primarily seen in low-income regions, the phenomenon…
To supplement the draft guidance for industry on Request for Quality Metrics, The US FDA have released a Quality Metrics Technical Conformance Guide to recommend how quality data should be submitted. The document contains information on how the US FDA wishes to receive, process and archive electronic data files for the quality metrics initiative, including…
Within the last 30 days, the US FDA released two new Warning Letters and yes-you guessed it, all contain data integrity violations. Lets look them below: Falsifying test data from a stability batch The latest Warning Letter is to an API manufacturer who acknowledged to the inspector during the inspection that a laboratory analyst substituted a reference…
Compounding pharmacies are in the FDA’s headlights again, with another pharmacy receiving a warning letter after an inspection, these inspections normal have findings relating to poor design of pharmacy clean rooms, i.e. CFR 211.42. Highlighted below within the text are the top 10 ranking 2014/15 FDA warning letters trends, full list here. The Warning Letter included:…
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