Comparative Study of Quality Assurance and Regulatory Guidelines Between Ireland (H.P.R.A.) and India (C.D.S.C.O)

dc.contributor.authorKoritela, Jahnavi
dc.description.abstractPractices (GMP). This knowledge is expressed by a variety of standards, rules, and definitions that specify exactly how the quality of pharmaceutical items should be. Pharmaceutical Quality assurance involves good manufacturing practices, inspection, quality risks management, pharmaceutical quality guidelines, and sampling operations, among others. Pharmaceutical quality assurance is achieved through the following Internal audits, employee training, minimizing or eliminating deviation, documenting control, ongoing improvement of quality management systems, and recurring management reviews. A number of research studies have compared pharmaceutical quality assurance in several countries across the globe, but it is only a few have compared pharmaceutical quality assurance between two countries, i.e., India and Ireland, having different pharmaceutical regulatory systems. Pharmaceutical quality assurance in nations such as India and Ireland are reinforced based on their respective regulatory bodies, such as CDSCO and HPRA, respectively. The HPRA governs the regulatory guidelines of medicines in Ireland, while CDSCO, on the hand, governs the regulatory guidelines of medicines in India. This research study aims at investigating how the quality assurance regulatory systems are varied in two different nations. The methodology of this research involves an online survey questionnaire using both a qualitative and quantitative approach. Data were collected from a total number of 99 research participants from both India and Ireland. These participants involved manufacturers, physicians and pharmacists. Secondary research has also been useful in this research study in terms of providing a comprehensive overview concerning the research topic. The conclusion of this research study was based on the general view of the pharmaceutical quality assurance systems implemented in both India and Ireland. This research study will serve as a reference material for improving the quality assurance system for pharmaceutical products in the two mentioned countries. Also helps for researcher's secondary research when dealing with a related research topic.
dc.titleComparative Study of Quality Assurance and Regulatory Guidelines Between Ireland (H.P.R.A.) and India (C.D.S.C.O)
dc.title.alternativeQuality Assurance, Regulation, Regulatory Guidelines, Pharmaceutical Industry, Ireland, India
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