ANEWrx utilizes USP grade, other compendial (European pharmacopoeia, Japanese pharmacopoeia) grade, or pharmaceutical grade pharmaceuticals, vehicles, and excipients with written certificates of analysis maintained on file in the ANEWrx.
ANEWrx conducts regular validation of its compounding processes. Additionally, samples are periodically submitted to an independent testing laboratory to assure that the content and potency of the medication preparations meet both compendial and recognized industry standards.
Samples of finished compounded doses are assessed assure that they meet quality standards for pH, fill volume, color, clarity, absence of visible particulate matter, and container/closure integrity.
The combinations of pharmaceuticals compounded in the ANEWrx pharmacy have documented stability in support of their beyond-use-dates at the time of dispensing.
Critical equipment in the ANEWrx facility, including balances and scales, dispensing pumps, and sterilizing filters, are calibrated and tested to assure their accuracy and functioning. Each step in the compounding process is double checked and documented for each batch of prescriptions compounded. Pharmacists and technicians observe one another during critical steps and sign-off on their proper completion.
Only one prescription formulation at a time is compounded in the ANEWrx pharmacy. Mixing containers are clearly labeled with their contents during compounding. A detailed label containing batch number, expiration date, formulation as well as the name and telephone number of the ANEWrx pharmacy is affixed to each compounded prescription.
The ANEWrx documentation system includes individual, unique prescription numbers and batch numbers that are associated with recorded identity, lot numbers, and expiration of each and every component used in the compounding process. |
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