Abstracts from the 1st JoPPP Conference on Pharmaceutical Policy and Practice

[摘要] Pharmaceutical industry is one of the main contributors of public health. In a pharmaceutical industry, Data integrity is one of the most important aspect that relates to drug quality, safety, efficacy and purity. Recently, many industries have been given warning letters due to the violation of data integrity and strict action had been taken by international and local regulatory authorities. Data integrity should be a part of pharmaceutical policy. It claims that product has been manufactured after meeting the predetermined specification and quality attributes and showed compliance of testing methods according to the guidelines given in official books. The FDA, USA considers integrity of data, from initial step where it is generated, and extending throughout its life cycle, to be a critical component which ensures that only high quality and safe drugs are manufactured. Hence, it is essential to record each and every detail of drug manufacturing and testing which should comply with cGMP practices. In future, the completeness, consistency, and accuracy of the data will decide the fate of the pharmaceutical companies.

[学科分类] 药理学