The two initiatives launched by the US FDA as part of the revision in its good manufacturing practices like the Process Analytical Technologies (PAT) and Pharmaceutical cGMPs are likely to be made mandatory for companies who want to register products in the US market. With the new approach, it is anticipated that the facility inspections would be conducted by the newly set up Team of Inspectorate prior to product registration so that the evaluation will not only focus on the applied product but also on an entirety of the manufacturing plant.
According to informed sources, the main objective to impose these revisions is to evaluate the FDA's updated systems in regard to drug product quality such as CMC review and the new inspection methods.
The USFDA is currently finalizing a system in which it has adopted a risk-based approach to modernise its regulations on drug manufacturing and product quality. The sources informed that this approach would ensure the most up to date concepts of risk management and quality system.
The sources said that the modernization adopted in the cGMP like PAT tools would facilitate the new concepts and innovations in pharmaceutical manufacturing leading to improving drug product quality.
However, sources in the Indian industry are of the view that the modernization and the new inspection requirements would make the product registration in the US market more stringent and only the companies those get adapted to the new standards can only go ahead with the drug registration procedures in the US market. And it will naturally affect the price competitiveness of Indian companies in the US market.