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| The FDA and Pharmacy Compounding
FDA Form 483, Part 11 |
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FDA 483 Observations in 503B Outsourcing Facilities
In this issue, we will continue our review of FDA 483 observations in 503B facilities; specifically, we will continue looking at the "Facility" section.
FACILITY, Part 2
- The floor in the aseptic area is not cured properly and appears dirty in several areas throughout the aseptic area.
- Your firm failed to ensure the material used to caulk and seal the ceiling tiles in the sterile suite is cleanroom grade.
- Buildings used to manufacture, process, package, or hold drug products do not have the suitable construction to facilitate cleaning, maintenance, and proper operations. Seals on panels are not fully seated onto the support railing allowing the collection of production dust and airborne particulates; the seals do not totally enclose the circumference of each ceiling tile, allowing open access directly into the ISO-8 Prep Room from the adjoining unclassified areas.
- The surface of the anteroom is constructed of laminated pressed wood where the laminate is coming off, thus exposing the wood surface.
- The floor trim below the sink in the ISO-8 Prep Room is coming away from the wall.
- Rust could be seen on the door handles for the ISO-8 anteroom into the ISO-7 Room and from the ISO 8 Prep Room into the ISO-7 room.
- Stickers attached to the support rails near the HEPA filters in all rooms could be seen peeling away from the support rail. The panel on the air return in the ISO-8 Prep Room had a screw coming away from the panel and the panel was not flush with the wall.
- Buildings used in the manufacture, processing, packing, or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds, insects, and other vermin. A dead insect was observed on the white baseboard in the room adjacent to the sterile mixing and filling rooms, just beneath the viewing window into the aseptic processing rooms. Also, dirt and dust was observed in the rooms adjacent where finished product is sent through directly from the cleanroom and sorted by batch.
More next week.
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Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Did You Know (On Patience)...
...that the following anonymous statement was made?
"Infinite patience is the price that many a man has paid for success. Gibbon worked twenty years on his Decline and Fall of the Roman Empire. Noah Webster spent thirty-six years on his dictionary. George Bancroft spent twenty-six years on his History of the United States." (Anon)
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Thoughts of the Week (On Patience)
"If I have ever made any valuable discoveries, it has been owing more to patient attention, than to any other talent." (Sir Isaac Newton)
"How poor are they that have no patience." (Shakespeare)
"Patience is bitter, but its fruit is sweet." (Rousseau)
"There are times when God asks nothing of his children except silence, patience and tears." (C.S. Robinson)
"He that can have patience can have what he will." (Benjamin Franklin)
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Get a Sample of IJPC
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Looking Back
Dan's bristles scratched,
Bridget's nose,
That's when
Her wild Irish rose!
Burma-Shave
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Questions Answered in the Upcoming Nov/Dec 2021 Issue of IJPC
Compounding Pearls - Wound Care: Drugs and Formulations for Dermal Healing. Part 4: Insulin
- In which dosage forms can commercially available insulin be compounded for topical administration to promote dermal healing?
- How does the impaired glucose metabolism of people with diabetes affect wound healing?
- By which mechanisms of action does topically applied insulin enable wound healing in diabetic patients and those without diabetes.
- In diabetic patients, what is the value for the level of glycosylated hemoglobin (HbA1c) that must not be exceeded to ensure successful glucose control and resultant efficient wound repair?
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