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PCMO L01-Setting Specifications for Biological Investigational Medicinal Products
1AstraZeneca Biologics, 633 Research Court, Frederick, MD 21703, USA; 301-398-2108; krauses@medimmune.com.
PDA Journal of Pharmaceutical Science and Technology
|October 3, 2015
Summary
This guide offers best practices for setting drug specifications during clinical development, aligning with ICH guidelines. It addresses challenges for investigational new drug/investigational medicinal product sponsors and demonstrates managing specifications within quality systems.
Area of Science:
- Pharmaceutical Development
- Regulatory Science
- Quality Management
Background:
- Setting product specifications is crucial for clinical biological drug substances and products.
- Current regulatory expectations and challenges exist for investigational new drug/investigational medicinal product (IND/IMPD) sponsors.
- ICH guidelines (Q8(R2), Q11, Q9, Q10) provide a framework for pharmaceutical development and quality systems.
Purpose of the Study:
- To provide guidance and best practices for setting specifications for clinical biological drug substances and products.
- To review regulatory expectations for specification setting within a control strategy.
- To illustrate managing investigational medicinal product specifications using a case study.
Main Methods:
- Review of ICH guidelines on pharmaceutical development, quality risk management, and quality systems.
- Analysis of current regulatory expectations for specification setting.
- Presentation of a case study on managing investigational medicinal product specification revisions.
Main Results:
- Guidance and best practices for setting specifications are provided.
- Challenges for IND/IMPD sponsors in the specification setting process are highlighted.
- A case study demonstrates effective management of investigational medicinal product specifications within a flexible quality system.
Conclusions:
- Effective specification setting is integral to pharmaceutical development and regulatory compliance.
- A flexible quality system facilitates the management and revision of product specifications.
- Justified specifications can be established for both early and late stages of drug development.
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