Quality assurance

Deviation from any process in pharmaceuticals can lead to a matter of investigation and root cause analysis. the manufacturer or responsible person shall be followed the following steps to do an investigation and root cause analysis by using corrective and preventive action. 1. Investigation/ Title for Root Cause Analysis: Start with the product’s name and … Read more

Way to Improve Investigation Report in Pharmaceuticals: It becomes very important for organizations to write an investigation report while getting any observations during routine audits or external audits. As before FDA had issued more than a hundred of 483 observations during the last few years. The organization gets a chance to comply with the observation … Read more

A deviation in pharmaceuticals may affect different areas including the materials, machines, and processes. the list of potential areas of deviation are: List of potential areas of deviations: Materials Equipment Process General practices documents practices test methods specifications Materials: Raw materials/components, as well as labeling and packaging components, must meet their quality specifications before their … Read more

IPQA Person plays a very important role in the quality of drugs or products during manufacturing. She/ He is responsible for carrying out all the processes as per standard operating procedures during manufacturing to ensure quality. The line clearance stage is the very crucial stage before starting a product. So the role of the IPQA … Read more