Today, life science products should also be affordable to patients and a reasonable business proposition for manufactures. These objectives can present challenges to manufacturers as they strive to gain production and process efficiencies.
Hal Baseman has written an interesting article for Pharmaceutical Online. Here is an extract:
- Science- and risk-based approaches should be used to obtain information needed to make decisions related to the evaluation, design, qualification, operation, and monitoring of sterile product manufacturing processes.
- Technology should be considered to mitigate or reduce the risk to product quality identified in sterile product manufacturing processes and operations.
- Traditional testing and monitoring methods as control strategies should be challenged to ensure they are the best means for aseptic processes.
- New products, therapies, and technologies will present challenges to traditional and existing methods for development, manufacture, validation, and testing of sterile products.
- Global health authority technical and regulatory guidance and requirements should be harmonized with regard to technical language and definitions.
Posted by Dr. Tim Sandle
