Key Aspects of Analytical Development In-House Training

The analytical aspects of the control strategy will be covered as well analytical documents for the submission.

Overview

The field of analytical development as part of the development of a new or generic drug product covers a huge range from the translation of the Quality Target Product Profile (QTPP) into the Analytical Target Profile (ATP) over the entire analytical procedure life cycle (i.e., development, validation, transfer, and maintenance of new analytical procedures) to key contribution to the control strategy of the commercial product (including definition of Critical Quality Attributes (CQAs), establishing of specification and justification for specification). In addition to these key elements for a successful development of a drug product analytical development is a key player in the stability studies and for the definition of the shelf-life of the medicinal product. Several regulatory documents are around analytical development which provide guidance to the key elements to this CMC topic such as the ICH guidelines for Pharmaceutical Development (Q8 (R2)), Analytical Development (Q14), Method Validation (Q2 (R2)), Specification (Q6A & Q6B), Impurities of new drug substances and products (Q3A & Q3B), and Stability testing (Q1A to Q1E). In addition, further scientific information can be found in pharmacopeial general chapters of the USP. These guidance documents form the basis of this in-house training around analytical development. In detail, the focus of this in-house training is on the specification of drug substances and products and it´s justification, determination of Critical Quality Attributes (CQAs), life cycle of analytical procedures, analytical documentation in terms of procedure content and validation / transfer of methods, and stability studies for drug substances and products. Furthermore, the analytical aspects of the control strategy will be covered as well analytical documents for the submission.

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RECOMMENDATION

Who should attend?

• Analytical Development
• Formulation Development
• Project Management
• Pre-clinical Development
• Clinical Development
• CMC Regulatory Affairs
• Quality Control
• Quality Assurance
• Drug Substance Manufacture
• Drug Product Manufacture