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ForumsCompounding & FormulationHas anyone dealt with lyophilization process for peptides? Page 5

Has anyone dealt with lyophilization process for peptides?

Dr.AddMedPHL Mon, Jul 22, 2024 at 12:05 PM 34 replies 2,498 viewsPage 5 of 7
LondonLisa
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Mar 2024
London, UK
Aug 7, 2024 at 8:44 AM#21
Dr.CardioMD said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

This matches mine closely enough to be worth saying so out loud.

Last edited: Aug 7, 2024 at 10:44 AM
32 7SaraMom3, Dr.MetabolicMD, RetaRick_CA and 29 others
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CanadaChris
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Nov 2024
Toronto, CA
Aug 13, 2024 at 2:26 AM#22
Dr.CardioMD said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials:

  1. State Board of Pharmacy license — check on your state BOP website
  2. FDA registration (for 503B) — check on fda.gov
  3. DEA registration if handling controlled substances
  4. PCAB accreditation — voluntary but demonstrates commitment to quality
  5. USP <797>/<800> compliance for sterile compounding

This takes 10 minutes of research and could save you from receiving substandard or unsafe medication.

31 6stefan_berlin, Dr.EM_Chicago, pete_RVA and 28 others
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Dr.PeteFamMed
Senior Member
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9,234
Jan 2024
Minneapolis, MN
Aug 18, 2024 at 8:11 PM#23
Dr.CardioMD said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

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.

30 5LindaRN_retired, tommy_boulder, hyun_seoul and 27 others
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DebRD_ATL
Senior Member
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Feb 2024
Atlanta, GA
Aug 24, 2024 at 2:00 PM#24

One thing that is still open after Dr.CardioMD’s answer:

Was that from a primary source or from a summary of one?

29 4PedsEndoPhilly, SleepDoc_PDX, RegAffairsDC and 26 others
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DerekSJ_a1c
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Aug 2024
San Jose, CA
Aug 30, 2024 at 7:52 AM#25
Dr.PeteFamMed said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.

Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 0 Form 483 observations in their last 4 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

Last edited: Aug 30, 2024 at 12:52 PM
28 3AttorneyGrant, DebRD_ATL, KristenIndy and 25 others
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