- Daily temperature and humidity monitoring and documentation.
- Daily refrigerator/freezer monitoring and calibration.
- Daily calibration of analytical balances.
- Chemical weight verified by printout.
- Calibration of pH meter before use on every compounded prescription (injectables, ophthalmic preparations, and other compounds).
- Ongoing training, testing and evaluation of aseptic personnel. Pharmacists and technicians training and validation in aseptic techniques, cleanroom regulations, and USP guidelines.
- Daily random sterility and pyrogen testing of products.
- Random endotoxin testing of product by independent laboratory.
- Bi-annual independent certification of Class 10,000 cleanroom and laminar airflow.
- In-house sterility validation of each autoclaved load and each filtration batch.
- Potency validation of finished compounds through weight, volume and yield checks in accordance with USP guidelines.
- Independent lab testing of air and surface samples for the cleanroom.
- Compliance with USP cleanroom guidelines for high risk compounds.
- Continuous cleaning of compounding environments with alternating cleaning solutions.
- Compounding software with backup for continuous record keeping for:
- lot numbers
- prescription numbers
- expiration dates
- USP & NF chemicals obtained from FDA approved suppliers.
- Regulated storage of raw materials and end products.
- Personnel trained and certified in compounding procedures.
- Personnel dedicated to policies and procedures to ensure quality.
Check chemical description for:
- particle size and shape
A. Prepare one compound at a time in designated area.
B. Weighing Chemicals
- Check weights before and after weighing.
- Check chemicals being weighed.
- Check protocols for compound preparation.
- Retrieve formula sheet.
- Check each chemical as you retrieve it.
- Place all chemicals to be weighted on left of balance.
- Place all chemicals already weighted to right of balance.
- Check chemical name as it is weighted.
- Check chemical as it is recorded on compounding log.
- Print out chemical weight and check chemical name, lot number and expiration date.
- When compound is finished, check chemical name as it is returned to stock area.