Abstract: Investigational New Drug (IND) applications must contain information allowing an assessment of whether or not the product is reasonably safe for initial testing in humans. This typically includes information pertaining to the chemical composition, manufacturing methods, stability, and controls used for manufacturing the drug substance and the drug product. Providing this information for investigational medicines can be more complex where the manufacturing process may not yet be fully defined. Sterilizing filtration should be qualified during early clinical phases to demonstrate that it is effectively providing a sterile product without adversely affecting its properties. The filter, as critical equipment used for manufacturing sterile phase 1 investigational drug, should not contaminate or otherwise react with, add to, or be absorbed by the drug. In order to assess its performance and thereby ensure the quality of the product, several aspects have to be examined including bacterial retention, chemical compatibility, extractables and adsorption. Based on our experience at Merck Millipore, you will learn about the key elements of sterile filtration validation, along with understanding more about global regulatory guidance for developmental phase drug products.
New Guideline on Elemental Impurities and its Implication
Presenter: Ulrich Reichert , Global Regulatory Management, Merck Millipore
Abstract: The International Committee on Harmonization (ICH) has recently published the guideline ICH Q3D to control elemental impurities. This new guideline will have huge impact on the control strategy of metal and other inorganic impurities for drug products worldwide. Elemental impurities may arise from elements that have been added intentionally, or that may be presents as contaminants. This webinar provides an overview of the current and upcoming regulatory requirements (ICH Q3D, USP, EMA-Guideline) and will outline the scope of the current regulation on elemental impurities. The impact on drug product and pharmaceutical starting materials will be discussed and the control strategies of ICH, USP and the existing EMA guideline will be compared. A risk based approach for assessment and control of elemental impurities will be suggested to cover the new regulation.