Month: January 2019

What is the Difference between Recall & Mock recall in Pharmaceutical


What is Recall of Product : A product recall is a request from a manufacturer to return or removal of a  marketed product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller/ manufacturer at risk of legal action. The manufacturer not only has  to pay  the … Continue reading What is the Difference between Recall & Mock recall in Pharmaceutical

Good Documentation Practices (GDP) in Pharmaceuticals


What is Document: A piece of written, printed, or electronic matter that provides information or evidence or proof of any activity that serves as an official record. Why Good Documents are Required in Pharmaceuticals : 1.If it isn’t documented, it didn’t happen & we document to provide written proof that something happened. 2.For regulatory requirements … Continue reading Good Documentation Practices (GDP) in Pharmaceuticals

Data Integrity Principles ALCOA & ALCOA PLUS in Pharma


Data Integrity Principles : Data Integrity as per United states Foods & Drugs Administration (USFDA) : Data integrity refers to the completeness, consistency, and accuracy of data. Complete,consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate (ALCOA). Data Integrity as per Medicines and Healthcare products Regulatory Agency … Continue reading Data Integrity Principles ALCOA & ALCOA PLUS in Pharma