Designing appropriate product specifications for parenteral products

Instructor: Barbara Berglund
Product ID: 701932
  • Duration: 60 Min

recorded version

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Training CD

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Read Frequently Asked Questions

This webinar will focus on defining the appropriate procedures and establishing appropriate specification limits for lyophilized sterile parenteral products.

Why Should You Attend:

During the early phases of drug and formulation development, discovery regarding the quality attributes of a new drug substance or a new drug product emerge. Setting specifications is a critical part of the development, as this ultimately defines how a drug product can be considered, safe, effective and of an appropriate quality.

Lyophilized products to be used for injection have some typical requirements for appropriate testing. The appropriate tests are based upon determining the quality and efficacy of the drug, which is impacted not only by the manufacturing process but also by the physical changes which take place via lyophilization.

There are some tests which are commonly used to measure the quality and efficacy of the drug product, and these will be discussed. The discussion will focus on defining the appropriate procedures and establishing appropriate specification limits. The manufacture of sterile parenteral products includes the requirement of maintaining a higher requirement of safety for drug injection. There are some key factors involved in the testing for safety and how specifications will be determined.

Areas Covered in the Seminar:

  • ICH guidelines for procedure selection.
  • ICH guidelines for specification establishment.
  • Considerations for sterile drug products.
  • Considerations for lyophilized drug products.
  • Guidance for appropriate direction during early development phases.

Learning Objectives:

To understand the requirements for sterile parenteral drug products, especially focused on lyophilized products, when establishing procedures and specifications

Who Will Benefit:

This webinar will provide valuable assistance to all pharmaceutical personnel in

  • QC functions in general
  • QC testing groups
  • QC investigation groups
  • Lyophilization development scientists
  • QA functions in general
  • QA groups involved in specification creation and approval

Instructor Profile:

Barbara Berglund , has been working in the pharmaceutical industry, specifically with sterile parenteral dugs, for over 10 years. Her experience includes her current role as a QC Manager as well as roles in the laboratory, project management, and clinical trial manufacturing. The QC group she manages is directly responsible for method transfer and validation activities in support of contract manufacturing clients. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007 and her Green Belt certification in 2008.

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