INVESTIGATION SUPPORT
Sometimes, certain incidents can occur during the development or testing process of drug products or medical devices which can influence their efficacy. Investigation support is an essential aspect that helps ensure the safety and effectiveness of pharmaceutical products.
The primary goal of investigation support to determine the root cause of the problem and implement counteractive and preventative actions to mitigate the risk of recurrence. Once the issues are identified, a report is prepared to be reviewed by a team of experts to understand the severity of the issue.
Investigation support typically involves a series of processes:
- It starts with an initial assessment of the issue to determine the scope and severity of the problem.
- Root cause analysis involves reviewing manufacturing processes, testing protocols, or other factors that could have contributed to the problem.
- Once the root problem has been determined, the team develops a Corrective and Preventative Actions (CAPA) to address the issue and prevent the reoccurrence.
- Throughout the examination process, the team documents all of their findings and actions taken to address the issue.
At PLS Analytical, we ensure the safety, efficacy, and quality of all our pharmaceutical products
Our focus always remains on developing the highest quality products and customer satisfaction. Our cGMP facility and qualitative measures follow strict FDA suggestions and USP requirements to identify the root cause and take corrective and preventive actions.
Significance of Investigation Support
Investigation support is of paramount importance in the pharmaceutical industry for the following reasons:
- Investigation support helps our company to identify and mitigate potential risks associated with their products or manufacturing processes.
- Examination of procedures helps pharmaceutical companies continuously improve their products and processes, which leads to better results and higher efficiency of drugs and medical devices.
- It can help prevent expensive litigation and product recalls.
- Investigation support can help companies to comply with various regulations and guidelines set forth by regulatory bodies.