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The coating of a surgical mesh with broad spectrum antibiotics has proven in multiple applications to inhibit colonization of bacteria at the surgical site thus significantly reducing post-surgery complications caused by bacterial infections. The most commonly used broad spectrum antibiotics used for this purpose are minocycline and rifampin. While the addition of these antibiotics to the surgical mesh offers significant benefits to the patient, the project teams needs to be prepared for the challenges presented by coating a surgical mesh with antibiotics.
Following the successful completion of the extraction studies on the container closure system, the development team must now start the process of developing and validating analytical methods for the detection of leachables in the finished drug product. Regardless of the type of drug product, the development team needs to consider the following:
· Selection of target leachables
· Selection of analytical methods and conditions
· Method sensitivity requirements
· Drug Product Specific Challenges
Each of these topics will be discussed in separate white papers. This paper will focus on method sensitivity requirements.
Following the successful completion of the extraction studies on the container closure systems, the development team must now start the process of developing and validating analytical methods for the detection of leachables in the finished drug product. Regardless of the type of drug product, the development team needs to consider the following:
Each of these topics will be discussed in separate white papers. This paper will focus on the selection of analytical methods and conditions.
Following the successful completion of the extraction studies on the container closure system, the development team must now start the process of developing and validating analytical methods for the detection of leachables in the finished drug product. Regardless of the type of drug product, the development team needs to consider the following:
Each of these topics will be discussed in separate white papers. This paper will focus on the selection of target leachables.
It may sound trite, but a quality organization must meet the demands set for a quality organization every day. Those of us facing this reality may give a knowing nod and smile upon hearing this obvious fact. Those working at some distance from it may think the statement is just another attempt by the Quality Assurance Unit to blow its own horn. This is a problem, because it is not the Quality Assurance Unit (QAU) that makes a quality organization. Rather, it is management’s commitment to and involvement in quality that rolls everyone up into the quality organization, including of course those identified as working in the QAU.
Manufacturers of parenteral drugs are familiar with the requirement to perform extractables and leachables testing on the primary container closure systems used with their drug products. These container closure systems often consist of glass or plastic stoppered vials and the contents can be either a liquid, powder, or lyophilized drug product. However, this may not be the only extractables and leachables (E&L) testing requirement if the parenteral drug product is reconstituted and/or diluted in an IV bag of diluent to form an admixture and delivered to the patient by infusion. Below are some common questions from Parenteral Drug Manufacturers on their requirements to perform E&L studies on IV bags and infusion devices.