Blog Compounding Documentation 
The FDA Law Blog
FEBRUARY 2, 2025
This also includes additional requirements for pharmacies that engage in sterile and complex nonsterile compounding. Specifically, the change of ownership/location documents are quite a bit different and include some new and helpful information to assist applicants wading through the very confusing and cumbersome licensing process.
Omnicell
JANUARY 10, 2023
So why, as clinicians, are we not focused on improving the documented one in 10 inaccuracies in sterile compounded products? It’s well documented that manual processes are archaic and inaccurate, and organizations like ISMP, ASHP, and many others agree things need to change.
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The FDA Law Blog
SEPTEMBER 11, 2024
FDA says that highly potent compounds – again, as defined in ICH M7(R2) – pose risks below that limit. We note that the other FDA guidance document on nitrosamines addresses NDSRIs. Using the guidelines found in the ICH M7(R2) , FDA set an AI threshold of 1.5
ISPE
MARCH 16, 2023
In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. ISPE Good Practice Guide on Containment for Potent Compounds 4. Environmental monitoring is another important aspect of Annex 1.
Omnicell
JANUARY 10, 2023
Compounding these challenges is that each vaccine brand requires different storage requirements with regard to temperature and beyond-use date (BUD) for each temperature type (frozen, refrigerated, and room temperature). The good news is that there may already be solutions embedded in your health system.
ISPE
JUNE 21, 2023
Trudy Patterson Wed, 06/21/2023 - 15:08 iSpeak Blog iSpeak Paperless Validation Systems: Truly Paperless? If It Is Not Documented, It Did Not Happen. If it is not ’documented’ it did not happen. We have seen plenty of examples over the years of insufficient documentation, risk assessments, requirements, testing, etc.,
Impact Pharmaceutical Services
SEPTEMBER 15, 2023
Structure-based drug design has evolved, facilitating the exploration of novel chemical probes and lead compound potency, and molecular docking utilizes target structures to predict interactions and offers simplicity and speed. This shift from a linear to a network approach enhances the potential for one drug to target multiple sites.
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