Monitoring Production Processes:
Continuously observing and verifying that manufacturing and packaging processes adhere to SOPs, GMP, and other regulatory requirements.
Line Clearance:
Ensuring the production line is free from any previous products, materials, or debris before starting a new batch.
In-Process Quality Checks:
Performing various checks during manufacturing and packaging, such as weight variation, tablet hardness, and other relevant parameters.
Documentation Review:
Verifying and reviewing batch manufacturing records (BMR) and batch packaging records (BPR) for accuracy and completeness.
Sampling:
Overseeing the sampling of raw materials, in-process products, and finished goods to assess their quality.
Deviation Management:
Identifying, reporting, and investigating deviations, non-conformances, and out-of-specification (OOS) results.
CAPA Support:
Assisting in the implementation of corrective and preventive actions (CAPA) to address identified issues.
Documentation and Reporting:
Maintaining accurate and up-to-date records of all IPQA activities and generating necessary reports.
Collaboration:
Working with quality control (QC) and production teams to resolve quality-related issues and improve processes.
Audits and Inspections:
Participating in internal and external audits and inspections related to quality assurance.