Pharmaceutical industry, safety concerns

Impurities in drug substances and drug products continue to be a source of great concern, discussion, debate, and research. " These concerns and debates typically center on the potential safety risks associated with impurities due to contamination and the setting of acceptance criteria. However, the bulk of the work being performed in the pharmaceutical industry, with respect to impurities, is focused on the isolation, identification, qualification and quantification of impurities that are found as a result of the manufacturing process or through chemical decomposition. On the... 

The pharmaceutical industry presents many new challenges to such a person which include the interface with pharmacy and pharmacology, toxicological research, human volunteer studies, clinical trials and post-marketing surveillance to name just a few. Product safety is a factor which impacts on all of those endeavours and the pharmaceutical physician will be expected to work and provide advice within that framework. It will be clear to anyone that evidence of lack of safety in a medical product is not good news for the company concerned and that some level of protective action will often be required which in extreme circumstances may involve product withdrawal. It is, therefore, essential that the pharmaceutical physician should be absolutely clear what constitutes lack of safety in relation to the intended use of the product. 

In the food and chemical industry, continuous production lines play an important role, whereas the pharmaceutical industry production is mainly based on a batch type procedure. Concerning the safety of a dosage form... 

There are three types of safety pharmacology studies conducted in the pharmaceutical industry, 1) single dose core portfolio preclinical safety studies conducted to Good Laboratory Practise (GLP) 2) supplemental studies of compound specific effects after chronic dosing that are conducted when results from the core battery of tests raise concern and 3) frontloading safety studies conducted in the drug discovery function with the aim of designing safety liabilities out of the lead compound series. 

---