Classification, Description, and Prevention of Errors
Compounding errors can be divided into the following categories:
- General Errors,
- Incorrect Ingredients,
- Incorrect Concentration,
- Incorrect Use of Equipment,
- Physicochemical Issues,
- Microbiological Contamination,
- Analytical Testing Issues,
- Microbiological Testing Issues, and
- Miscellaneous Errors.
We will continue to look at errors using the format or subject-headings of "Error Type," "Description," and "Avoiding the Error."
MICROBIOLOGICAL TESTING ISSUES
||Avoiding the Error|
|Sample preparation and handling
||Some compounded preparations are not prepared or handled properly before testing for microbiological growth, sterility, or endotoxins.
||Confirm the proper method of sampling, handling, and transporting the samples to the laboratory so they will be properly received. Ship them overnight, and do not ship them over the weekend.|
|Potential problems with laboratories
||Some laboratories may actually contaminate the samples after they are received at the microbiological laboratory, resulting in reporting of incorrect results.
||Check with the laboratory to confirm it is registered and inspected by FDA. Confirm its personnel are properly trained and follow strict SOPs. Occasionally, send duplicate samples to two different laboratories and compare results.|
Loyd V. Allen, Jr., PhD, RPh
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition