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Common compounding problems causing a sample to fail: case studies
Berenice Dethier, Research Chemist II

A potency test measures the amount of API in a formulation to ensure the product is within its specifications. Criteria for acceptance are set by the client and/or follow the industry benchmarks (generally set by USP).

Several factors can contribute to a failing potency result.  Investigating the root cause of the failing potency test is an important practice to characterize the true cause(s) of the failure. The goal of the out of specification (OOS) investigation is to identify what, how, and why the failure occurred. To answer all three questions, OOS investigations should include a comprehensive review of all aspects of the formulation procedure. The review typically includes everything between the acceptability of the raw materials to the validity of the potency test result. Understanding the factors that contributed to the potency failure allows the pharmacist a more strategic approach in eliminating future failures. The more specific the findings into the failure, the easier it is to properly address.

A sterility test detects microbial contamination and provides data to determine if your product is ready for release.  A “Sterile” result indicates no contaminating microorganism is found in the sample. A “Not Sterile” result indicates microbial growth and the product examined does not comply with the test for sterility, unless it is demonstrated that the test is invalid. An investigation is performed to determine if a sterility failure is invalid due to laboratory error. 

Drug diversion is the illegal practice of transferring regulated pharmaceutical agents from legal sources for illicit use.  Instances of drug diversion within the workplace pose a significant risk of civil liability to the employer.  Not only can harm befall the drug-diverter, but contaminated drug products also pose a significant threat to patients including risk of infection, allergic response to substituted components within the drug product, and death. 

Microbial identification is an important component of a quality assurance program; specifically as it relates to environmental monitoring (EM), raw material and final product bioburden assessment, and out-of-specification (OOS) investigations.

The Essentials of United States Pharmacopeia Chapter <51> Antimicrobial Effectiveness Testing and Its Application in Pharmaceutical Compounding

Antimicrobial preservatives are excipients added to multi-dose containers of both sterile and nonsterile drug products. Antimicrobial preservatives are used primarily to inhibit growth of microbial contamination occurring during the period of use. Demonstration of antimicrobial preservative effectiveness is required for these functional excipients. This article reviews key factors for consideration in the selection of preservatives, principles of the preservative-effectiveness test, and the significance of requirements for preservative-effectiveness testing in the compounding practice.

Some of the same challenges in creating a formulation are also related to getting accurate and representative results from your Analytical Testing.  This article outlines how to avoid some common issues to help ensure your formulation is safe and effective for patients.

Potency tests, known as quantitative tests, are designed to determine how much of the active drug is in the sample. Stability tests are used to determine a beyond-use date for a preparation. Employing the proper method to determine potency or stability is key to understanding the difference between potency testing and stability testing.

Particulate Matter Testing
Cindy Pickens, ARL Bio Pharma Laboratory Supervisor

Particulate Matter testing is performed on all parenteral solutions to determine the cleanliness and stability of the solution; and, is listed in USP <797> as a necessary component for quality assurance of compounded sterile preparations under the responsibilities of compounding personnel. It is also specifically outlined as a required test in several individual monographs such as Morphine Sulfate Compounded Injection.

Container Closure Integrity Testing
Avastin Stability and Release Testing
Stability Design Webinar
Quality Compounding Summit

The container closure system for a drug product provides critical protection for stability and sterility. Contaminants (such as microorganisms and reactive substances) could potentially cross through defective container closures putting the drug product and patients at risk...