Microbiology lab is manual process based lab, less automation than chemistry lab, less regulatory guidance for microbiologist so that DI issue is the major concern in Microbiology lab. The sterility test, the bacterial endotoxin test and microbial enumeration test which involves counting microbial colonies are mostly prone to DI issues. Common DI issues in microbiology…
Data integrity refers to the completeness, consistency, and accuracy of data. Where complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA) throughout the lifecycle of the product. Data integrity is a requirement of current good manufacturing practice (cGMP) for drug substances and drug products as…
Data integrity in the analytical laboratories is an area of increasing focus for regulatory authorities such as FDA, EU, TGA etc. Data Integrity The data which is attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). During regulatory inspection/audit analytical laboratories have to provide information about the validation of their methods and…
There are 20 main objective of data management and data integrity in pharmaceutical industry. Let’s check it out – 1. Ensure the accuracy and completeness of data. 2. Maintain data confidentiality and security. 3. Facilitate compliance with regulatory requirements. 4. Ensure consistency of data across different systems and platforms. 5. Facilitate efficient data retrieval and…
This article contains a collection of frequently asked questions that have been submitted by the industry to the APIC DI taskforce. Which is divided into following sections: Q1. What is the difference between a digital and an e-signature? A digital signature is attached to an electronic file and not maintained within an electronic system and…