Quality Assurance
Sterile Non-Hazardous Compounding <797>

 

Purpose/ Applicability:  The purpose of this standard operating procedure (SOP) is to provide an overview of quality-assurance activities for sterile preparations.

 

Scope: Applicable to anyone who prepares or checks sterile compounded preparations.

 

Definition(s):

 

SOP : Standard Operating Procedure

USP : United States Pharmacopeia

BUD : Beyond Use Date

 

Equipment: N/A

 

Procedure:

 

Background

 

• A quality-assurance program for sterile preparations is a system of written procedures and scientific measurements designed to ensure the maintenance of proper, accurate, and safe compounded preparations

 

• The safety, quality, and efficacy and/or benefit of compounded preparations depend on correct ingredients and calculations, accurate and precise measurements, appropriate formulation, conditions and procedures, and prudent pharmaceutical judgment

 

• As a final check, the responsible pharmacist shall review each procedure in the compounding process
  • To ensure accuracy and completeness, the responsible pharmacist shall observe the finished preparation to ensure that it appears as expected and shall investigate any discrepancies and take appropriate corrective action before the prescription is dispensed to the patient

 

• Personnel involved in sterile compounding must obtain additional, specific training and periodic retraining
  • A thorough quality-assurance program for compounded preparations requires documentation of both training and skill competency. 

 

 

 

General Process

 

• Appropriate equipment is obtained either by the manufacturer or by the responsible pharmacist upon purchase and shall be maintained, calibrated, and used properly according to SOPs

 

• When testing is outsourced, the PIC determines what to outsource, how to select the laboratory, and will develop ongoing relationships with those laboratories

 

• • For sterility testing, the VDL is utilized. The correct form should be completed (https://vetmed.illinois.edu/wp-content/uploads/2014/04/Micro_Submission_3.2021-1.pdf) and Molly Fleming should be contacted about setting up a date and time. Non-controlled substances can be left at the VDL to be discarded by them. Controlled substances must be brought back immediately after they are drawn up for testing and then wasted appropriately.
  • Currently, endotoxin outsourcing has been determined to be too expensive to complete and in house kits have not worked, therefore, dates on sterile products will not be extended at this time

 

• Testing methods for bulk substances and dosage forms can be found in the chart below.
  • All medications that are repackaged should be tested for sterility
  • Medications that are given the USP default dating do not require sterility testing
    • If it is determined that we want to extend dating beyond USP default then sterility testing of CSPs would be required

Selected Compendial Testing Methods for Bulk Substances and Various Sterile Dosage Forms 

	Testing Method (See Legend for Explanation of Abbreviations)
Bulk Substances and Dosage Forms	Wt	Vol	pH	Sterile	Endotoxin	PM
Injections	-	+	–	+	+*	+
Irrigations	-	+	–	+*	–	–
Ophthalmics	-	+	–	+*	–	+
+ = Test applicable; – = Test not applicable; Wt = weight; Vol = Volume; PM = particulate matter *Only test if extending beyond USP default BUD