-
An Analysis of 2019 FDA Warning Letters Citing Data Integrity Failures
By Mohammed Raihan Chowdhury Data integrity is a fundamental aspect of ensuring the quality, safety, and efficacy of pharmaceutical products. It refers to the completeness, consistency, and accuracy of data throughout the data lifecycle. Data integrity failures can compromise the reliability of data and lead to serious consequences for patients, manufacturers, and regulators. Therefore, the…
-
Regulatory Inspection Management in Pharmaceutical Company
Pharmaceutical companies are governed by regulations and thus regulatory inspection management is very important for pharmaceutical companies. They must follow the regulations and/or regulatory guidelines of the country where they are authorized to sell their products. Generally, the regulatory authority inspects the manufacturing site of the pharmaceutical company before giving a manufacturing license or approving…