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Specifications from a biotechnology industry perspective
1Genentech, Inc., South San Francisco, CA, USA.
Developments in Biological Standardization
|January 1, 1997
Summary
Global pharmaceutical production requires worldwide specifications for cost-effectiveness. Establishing these specifications needs robust protein knowledge, process control, and assay validation for regulatory harmonization.
Area of Science:
- Pharmaceutical manufacturing
- Analytical chemistry
- Regulatory science
Background:
- Emerging analytical technologies and global pharmaceutical markets demand cost-effective production.
- Effective pharmaceutical production requires deep understanding of protein characteristics and manufacturing systems.
Purpose of the Study:
- To highlight the necessity of global specifications for pharmaceuticals.
- To emphasize the importance of assay accuracy and precision in pharmaceutical testing.
Main Methods:
- Review of current analytical technologies and global pharmaceutical production trends.
- Analysis of the requirements for establishing worldwide product and process specifications.
- Discussion on the role of assay validation in pharmaceutical quality control.
Main Results:
- Worldwide specifications are essential for cost-effective global pharmaceutical manufacturing.
- Thorough protein knowledge, process control, and validated assays are critical for setting specifications.
- Harmonization of specifications among regulatory authorities is vital for future drug development.
Conclusions:
- Continued dialogue between industry and regulators is crucial for achieving global specification harmonization.
- Harmonized specifications will facilitate the development and accessibility of new pharmaceuticals worldwide.