Deconstructing the Regulatory Spiral
Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-05-15-2016
Volume 2016 eBook
Issue 2
Pages: s24-s30
Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.
Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.
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Articles in this issue
Measuring and Removing Genotoxic Impurities
Qualification and Validation of Single-Use Shipping Systems
The Evolution of Planning, Design, and Engineering—Flexibility Takes Center Stage
Revised ISO Cleanroom Standards Improve Air Cleanliness Classification
Lessons Learned Accelerate Vaccine Development
Protecting the Product and the Patient
Deconstructing the Regulatory Spiral
Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations
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