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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…
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Going Paperless: The Benefits of E-Document Management Systems in Pharmaceutical Industry
The pharmaceutical industry is highly regulated and complex, with strict requirements for document management. Paper-based document management is no longer feasible in this environment, as it is inefficient, error-prone, costly, and challenging to comply with regulations. On top of everything, paper documentation causes huge environmental pollution. Every year, $25-35 billion is spent in the U.S.…
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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…
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Specific Regulatory Requirements of ANVISA for Analytical Method Validation
The requirements for analytical method validation which are listed in “ANVISA RDC 166/2017-Validation of Analytical Methods” and “ANVISA RDC 53/2015- Guide on notification, identification, and qualification of degradation products in medicinal products,” and are going beyond those defined in ICH Q2(R1), FDA guidance for Industry and relevant chapters of USP, EP and JP are summarized…