Dr.EndoIndy said:Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 12 months from compounding date…
Agreed, with a caveat about community reputation: it is a lagging indicator. Reports arrive weeks after orders, so a supplier can look excellent for a month after quality has already changed.
From the other side of the consultation, briefly.
GMP compliance checklist relevant to compounded supply compounding quality:
- Clean room environment with HEPA filtration
- Environmental monitoring (viable and non-viable)
- Personnel training and competency assessment
- Validated analytical methods for testing
- Stability testing program
- Complete batch records and traceability
- Quality management system with deviation handling
A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.
Dr.GastroMayo said:GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…
Mine went the same way, slower. I had assumed I was the exception until I read this.
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Browse GL BiochemDr.GastroMayo said:GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…
Coming at Dr.GastroMayo’s question from a different direction. The pattern that distinguishes a bad batch from an exit is behaviour rather than product. A bad batch comes with communication, a reshipment offer and a batch number. An exit comes with slower replies, pressure toward less reversible payment methods, sudden discounting, and the same reassurance repeated without any new information. The product tells you less than the correspondence does.
Correct me if the detail matters more than I have assumed.
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