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ForumsCompounding & FormulationEndotoxin testing in compounded injectables — looking for input Page 7

Endotoxin testing in compounded injectables — looking for input

rick_sfbay Wed, Sep 10, 2025 at 5:43 PM 35 replies 1,765 viewsPage 7 of 7
Dr.AddMedPHL
Senior Member
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Mar 2024
Philadelphia, PA
Feb 3, 2026 at 9:55 AM#31

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.

13 11FitDadDave, RunnerRach, TrialNerd_Beth and 10 others
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DoseLogDan
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Feb 2025
Montana
Feb 14, 2026 at 11:26 PM#32
Dr.AddMedPHL said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

This is my experience too, for whatever a second data point is worth. The detail I would add is minor and it is already implied above.

14 12Dr.AddMedPHL, newstart_MO, mia_MS2 and 11 others
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TrialNerd_Beth
Senior Member
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Jan 2024
Bethesda, MD
Feb 26, 2026 at 12:51 PM#33
Dr.AddMedPHL said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

Adding the part of the answer the thread has not reached. If two explanations both fit, the useful question is which one predicts something the other does not. That is answerable; arguing about which sounds more plausible is not.

Last edited: Feb 26, 2026 at 4:51 PM
15 13TomTeleRx, DoseLogDan, SleepFixSam and 12 others
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Dr.PulmRoch
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Jun 2024
Rochester, MN
Mar 10, 2026 at 2:09 AM#34

The figures, for anyone assembling their own picture. Practical: whatever you change, write down the date and the reason. In three months the reason is what you will have forgotten, and the reason is what makes the record worth having.

Ask again with the specifics and you will get a better answer than this one.

Last edited: Mar 10, 2026 at 3:09 AM
16 14DebRD_ATL, KristenIndy, MarkLI_maint and 13 others
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DerekSJ_a1c
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Aug 2024
San Jose, CA
Mar 21, 2026 at 3:20 PM#35

A narrower follow-up, since the general answer is now clear:

What did you change at the same time, and can you separate the two now?

Last edited: Mar 21, 2026 at 8:20 PM
17 15AttorneyGrant, DebRD_ATL, KristenIndy and 14 others
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