Jessica Munson, M.S., ARL Bio Pharma Analytical Supervisor
What is a Master Formulation Record?
A Master Formulation Record is used to document the specific information for each individual batch and is an important component of regulatory compliance and effective process control. This detailed record of procedures describes how the drug product is to be prepared...
The Importance of Endotoxin Testing
Andrew Taylor, ARL Bio Pharma Microbiology Supervisor
In recent years, there have been instances of endotoxin-caused illness resulting from contaminated compounded sterile preparations. In 2015, an incident occurred where seven cases of endotoxin poisoning were related to contaminated glutathione infusions.
Pharmacists often want to assign a beyond-use date (BUD) on a drug product longer than USP guidelines to increase compounding efficiencies and reduce drug waste. For accurate BUD assignment, Stability-indicating methods are recommended as opposed to Potency methods. Stability-indicating methods are specifically designed to separate drug degradants from non-degraded drug (for more information about the difference between the two methods, see Stability vs. Potency testing article).
ARL now offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, and vials.
Three types of leaks that can be detected during CCIT include:
James Zellner, Technical Sales
Identification of a contaminant in a sterile preparation is vital to determining the origin of the microorganism and its avenue of entry. The organism’s identity, combined with environmental monitoring data, provides actionable information to improve a pharmacy’s processes and prevent future contamination.
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.