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The Importance of Testing Bulk Substances

A bulk substance, also known as an active pharmaceutical ingredient (API), is often the starting point of a compounded preparation.   Prior to use, compounding pharmacies and outsourcing facilities should confirm the quality of an active pharmaceutical ingredient to ensure consistency of the material as received from the supplier and suitability for use in a compounded preparation.  At a minimum, identity testing is recommended for each lot, but more rigorous testing should be evaluated.

Method Suitability and its Importance...

Sterility testing by USP <71> is a test used in tandem with other sterility assurance procedures and tests to ensure that a product is free of microbial contaminants and safe for patients to use.  For a sterility test to perform appropriately, a method suitability validation must be completed on each specific formulation to determine the appropriate test method.

Microbial Disinfectant Cleaning Challenge

James Zellner, ARL Bio Pharma Technical Sales

 

How do you know your staff is doing a thorough job disinfecting surfaces and equipment at your facility?  Do you have proof that your cleaning procedure is effective in removing potential contaminants from surface areas?

Benefits of Submitting Master...

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

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.

Importance of Forced Degradation...

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).

Container Closure Integrity Testing

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:  

  • entry of microorganisms
  • escape of the product dosage form or entry of liquids or solids
  • escape of nitrogen gas or entry of oxygen, water vapor, or air gases

Prevent Future Sterility...

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.

Potency Test Failure...

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.