by Dipti Gulati | May 4, 2023 | Blog
Organizations continuously face challenges related to quality improvements. Management trains front-line and quality management staff on different process improvement courses to improve the management of quality. Based on the training different quality improvement...
by Dipti Gulati | May 4, 2023 | Blog
Writing 483 Response can be a stressful process. However, it is beneficial to follow a systemic process to ensure that the response is adequate. The first step is to conduct a marketed product assessment to determine if 483 observations have any adverse impact on the...
by Dipti Gulati | May 2, 2023 | Blog
Regulators around the globe have issued guidance on data integrity in the last five years. As per FDA guidance, “Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible,...
by Dipti Gulati | May 1, 2023 | Blog
FDA guidance for handling OOS results was updated in May 2022 and is available on the FDA website. This guidance provides current thinking on the evaluation of out-of-specification results. MHRA guidance on handling OOS results was initially published in 2013 and was...
by Dipti Gulati | Apr 22, 2023 | Blog
GLP (Good Laboratory Practices) is a quality system for organizational processes and management controls under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported (21 CFR Part 58 and OECD...
