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LIVE WEBINAR

Release & Stability Testing Requirements for Parenteral Drug Products

November 3, 2022

11:00 am EDT

Shiri Hechter

Parenteral products are sterile drugs, solutions, emulsions, suspensions. Parenteral products are unique from any other type of pharmaceutical dosage form for the following reasons: All products must be sterile. All products must be free from pyrogenic (endotoxin) contamination.

Release and Stability testing are a vital part of new drug development and is conducted throughout a product’s life cycle. These studies confirm that the quality, safety, and effectiveness of drug products are preserved all through the shelf life as an essential requirement. This presentation will provide a brief overview of the Parenteral Drug Products Release testing as well as the ICH guidelines for Stability testing.

 

Shiri Hechter

Senior Lab Operations Manager

M.Sc., ASQ CQA and CSSGB Shiri Hechter is an organic chemist. She received her master’s degree in organic chemistry from Tel-Aviv University in 2005. She began her career at Gibraltar Labs in 2006. She started as a Chemistry Group Leader in the analytical chemistry department. After two years, Shiri was promoted to the QA department as a Quality Assurance deputy — with a focus on analytical chemistry. During her time in QA, Shiri completed CQA (Certified Quality Auditor) and CSSGB (Certified Six Sigma Green Belt) training with the American Society of Quality (ASQ), and currently holds both certifications. In 2017, Shiri moved back into operations, as a Senior Lab Operations Manager. As a Senior Lab Operations Manager, Shiri oversees all analytical testing, routine and validation, particulate testing, stability testing, molecular biology and microbial project development and fills the role as the main subject matter expert for analytical testing — giving support to the technical service teams.