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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."
ANALYTICAL TESTING ISSUES
| Error Type |
Description |
Avoiding the Error |
|---|
| Sample Preparation and Handling |
Improper sample submission has led to OOS results. |
Contact the analytical laboratory for the proper method of sampling (number of samples, packaging, storage, etc.) and shipping. Ship overnight if possible, and do not ship if the sample will be in transit over the weekend. Develop and implement SOPs for the different samples that are submitted. Use laboratories, licensed and inspected by the U.S. Food and Drug Administration (FDA), that will work with you when you have OOS results. |
| Potential Problems with laboratories. |
Some laboratories may inadvertently use improper sampling methods, extraction procedures, and analytical methods for the analyses being done. |
Provide the laboratory with complete information on the sample so it can appropriately perform any extraction as required for the API. This is especially critical when cellulose derivatives, polymers, etc. are used that may entrap the API and prevent its complete extraction. Confirm that the analytical methods being used provide you the correct and complete information. If OOS results are received, contact the laboratory to help identify the problem and discuss methods of correction. Occasionally, send duplicate samples to two different Laboratories and compare results. |
| Improper BUDs |
In the past, not all laboratories obtained data using stability-indicating analytical methods. |
BUDs must be determined using stability-indicating analytical methods. Confirm this with the laboratory used. |
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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