Quality-Control Analytical Methods: A Guide to Quality Control Testing for the Compounding Pharmacist

Abstract

Testing practices must be in place for pharmacies that blend sterile and nonsterile preparations, and any like procedures must meet the standards station forth in United States Pharmacopeia Chapters and as well as other related chapters. Having written managements that meet the standards of the United States Pharmacopeia not alone aids in assuring the safety of the patients who use these preparations, on the contrary also provides some protection for the pharmacy should quality control/quality assurance issues be questioned by the agency of regulatory authorities. A pharmacy also must consider its state board of pharmacy regulations when setting up its manner of proceedings To provide guidance in power testing of sterile and nonsterile preparations, a compounding pharmacy should consider having a standard operating practice in place.

Although a small in number years have passed since United States Pharmacopeia (USP) Chapters and were published, there are still many questions concerning quality superintendence (QC) testing of compounded preparations. This article furnishes a brief review of the standards at handed by these USP chapters, as well as relevant standards from USP Chapters and and their testing requirements. It also presents a model potency testing protocol that may help guide pharmacists in initiating a QC/quality assurance program for their compounding pharmacy.

Besides USP standards, the other important factor to consider for testing requirements is the regulations of the individual state boards of pharmacy. Many states are adopting language similar to that of the USP, on the contrary others have written laws that specify more demanding testing requirements.

There are sum of two units vital questions to ask when initiating a QC testing program: (1) which preparations must be trialed according to USP Chapters and and my state board of pharmacy; and, the more general question, (2) which should be ordealed as part of an acceptable QC program?

Which preparations must be tested?

USP Chapter

This chapter, which interests nonsterile preparations, states that "compound preparations are to be prepared to make secure that each preparation shall contain not les than 900 percent and not more than 1100 percent of the theoretically calculated and labeled quantity of active ingredient by unit weight or volume...."1 The verbiage of the chapter does not specifically state, however, that a preparation must be experimented to show that it is within these limits.

USP Chapter

This chapter, which overlays compounded sterile preparations (CSPs), is more specific when it advances to testing requirements. Testing is specified for sum of two units specific situations: (1) to reach forth storage periods and (2) for finished preparation release checks and ordeals under prescribed circumstances.

Extend Storage Periods

USP Chapter outlines true specific storage periods for low- medium-, and high-risk horizontal CSPs. To extend storage beyond these somewhat confining periods, these preparations must pass a sterility trial (defined in USP Chapter )1 one time the preparation passes the proof for sterility, the active ingredient energy beyond-use date (BUD) is the determining factor for the longitudinal dimensions of time that the preparation can be stored. In more [i]or[/i] less cases, as when the force decreases rapidly, the active ingredient power determines the overall BUD, irrespective of comes of a sterility test (Figures 1 and 2)

Finished Preparation Release Checks and trials

Information on finished preparation release checks and trials is specified in USP Chapter 1 All high-risk horizontal CSPs for administration by injection into the vascular or central nervous a whole meeting the following criteria must be trialed to ensure that they are sterile before they are dispensed or administered:

* CSP prepared in assemblages of more than 25 identical individual single-dose packages (eg ampules, bags, syringes, vials)

* CSP in multiple-dose vials for administration to multiple patients

* CSP expos longer than 12 hours to temperatures from 2?° to 8?°C or longer than 6 hours to temperatures warmer than 8?°C before they are sterilized1

Under any of these conditions, the CSP must be trialed for sterility under the conditions of USP Chapter (Figure 3) and USP Chapter 1

Also included in USP Chapter is a section identifying the requirements for physical inspection of the preparation for evidence of visible particulates or foreign matter, container-closure integrity, and any other apparent visual defect1

The Finished Preparation Release Checks and experiments section of USP Chapter specifies that a CSP must be assayed by means of methods that are specific for the active ingredients if the vigor of finished CSPs cannot be confirmed as accurate based upon the following three inspections:

1 That labels of CSP bear correct names and amounts or concentrations of ingredients; the total volume; the beyond-use date; the appropriate route(s) of administration; the storage conditions; and other information for safe use.

2 That there are correct identities, purities, and amounts of ingredients by means of comparing the original written order to the written compounding record for the CSP