| Question |
Wedgewood Pharmacy |
Other Compounding Pharmacy |
| Are you PCAB Accredited®? |
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| Are you committed to compliance with the USP <795> and USP
<797> guidelines for non-sterile and sterile compounding? |
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| To achieve sterility, do you filter (0.2 micron) in an ISO
Class 5 laminar air-flow hood contained in an ISO Class 7 clean
room? |
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| Is the air quality in your sterile-compounding lab engineered
for HEPA filtration to minimize particulates? |
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| Is every step of the compounding process from prescribing to
compounding and labeling through dispensing reviewed and verified
by a licensed pharmacist? |
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| When filtration is not appropriate, do you terminally sterilize
via autoclave or gamma irradiation to achieve sterility? Do you
perform post-filtration filter integrity testing? |
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| Do you obtain Certificates of Analyses for all pharmaceutical
ingredients? |
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| Do you purchase pharmaceutical-grade chemicals (USP, NF
equivalent) from FDA-registered suppliers? |
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| Do you have systems in place for handling complaints, adverse
events, and, if necessary, issuing a recall? |
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| Do you have a dedicated quality department that monitors, logs,
and tracks all medication testing? |
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| Do you maintain both master formulas and lot-specific batch
records for all compounds? |
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| Can you immediately trace a prescription back to the original
batch record and the source of the ingredients? |
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| Do you have a sterile environmental-monitoring program in place
to help ensure aseptic conditions? |
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| Do you have an independent, third-party lab perform sterility
analysis on every batch of sterile compounds? |
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| Do you have an independent, third-party lab perform endotoxin
analysis on every batch of sterile compounded injections? |
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| Do you conduct monthly lab tests of air and surface samples in
your clean room and other controlled environments? |
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| Do you obtain independent, routine certifications of your clean
rooms and laminar airflow hoods? |
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| Do you perform quality-control testing of finished compounds
through weight, volume, and yield checks? |
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| Do you perform pH testing on injections, ophthalmic
preparations, and other compounds? |
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| Do you conduct media fill, surface, fingertip, and volumetric
air sample testing? |
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| Are all sterile medications quarantined until testing is
completed? Does the quality-compliance team review testing results
and release the medication? |
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| Do you perform identification testing on Active Pharmaceutical
Ingredients? |
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| Do you perform routine audits of your vendors to ensure
compliance with FDA regulations? |
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| Is your staff properly trained and evaluated in aseptic
manipulation skills, gowning technique, and clean-room use? |
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| Are all pharmacy compounding technicians evaluated twice
annually for proficiency in compounding multiple dosage forms,
including potency testing of the resulting compounded preparations? |
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| Do all aseptic pharmacists and technicians complete a 40-hour
course on aseptic compounding? |
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