Risk Management
Controlling nitrosamines impurities in pharmaceutical products
Nitrosamines are known environmental contaminants found in water and foods but have recently been identified in multiple drug products
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A case for better pandemic preparedness
While COVID is not yet behind us there has never been a better time to consider the meaning of national resilience and to prepare for the next threat
How Risk-based Approaches to Computer System Validation Support Cost-Effective Compliance and Improved Patient Safety
At the heart of almost all life science and pharmaceutical industry operations are digital information and document handling systems From the earliest clinical phases to the last postapproval study the data and technical documentation these systems manage are essential to the safe effective creation of medicines and therapeutics for all patients
Predicting Quality Risks in Pharmaceutical Production
Incorporating internal and external signals
Proactive quality risk management provides numerous advantages to pharmaceutical companies such as less rejected batches and less drug shortages FDA a It helps to minimise and predict potential negative impact on patients caused by quality issues and it encourages manufacturers to adopt suitable continuous improvement programs
Patents and Global Drug Development
Bringing a drug to market is a multiphased process consisting of research development clinical trials marketing and sales Frequently one or most of these phases occurs in a country other than the USA If a company has ties to the USA it must be concerned about the long arm of US patent law for every phase of a drugs life cycle specifically how the l...
