Regulatory CMC Changes for Pharmaceutical Products
SummaryAll the biopharmaceutical companies must follow respective nation’s laws or regulations in order to develop, manufacture and sale their pharmaceutical products.
- Author Name: Katherin Taylor
All the biopharmaceutical companies must follow respective nation’s laws or regulations in order to develop, manufacture and sale their pharmaceutical products. Before any biopharmaceutical product goes in to market, it has to get marketing authorization from the relevant health authorities. Market authorization is issued on the basis of an assessment of submitted information that describes the quality, safety and efficacy of the product for a specified indication.
Applicants and manufacturers often implement changes in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling established in an approved application for licensed biological products for a variety of reasons. As a result of global regulatory requirements, many changes cannot be implemented until health authority reviews and approves them.
Health authorities often have several questions during their reviews for which a manufacturer needs to prepare for many rounds of responses. Multiple reviews of the same information can lead to high costs, a more complex supply chain, and a need for sophisticated systems to maintain regulatory compliance which in turn can lead to an increasing number of errors that affects regulatory compliance, complexity in cost management, and reduced resources as well as increase in the risk of an interrupted supply of drug products. Read more @ http://bit.ly/2GS0V1H