IPQA Personnel comes under Quality assurance Department and they are responsible for monitoring shop floor activities and ensuring quality of the Products at every stage of manufacturing right from dispensing of starting materials to the dispatch of finished products
let us see various functions performed by IPQA Personnel. These include but not limited to
- line clearance activities
- In-Process checks
- Sampling
- Process validation
- Batch record review
- Maintenance of IPQA lab
- Batch release
- cleaning validation
- Process monitoring
- Environmental monitoring
- Deviation management
- Training on GMP & GDP
- SOP Revision and control
IPQA Personnel ensures quality of the Pharmaceutical Products at every stage of manufacturing by following the Standard operating procedures and good documentation practices
Line clearance : IPQA personnel shall be responsible for line clearance before commencement manufacturing activities like dispensing, granulation , blending, compression , coating, inspection and packing
During line clearance IPQA personnel shall ensure no remnants of previous products are present in the area , the environmental conditions are within the limits , all equipment’s are in cleaned state and area status is updated – this shall be done visually inspecting the area and checking the documents
In-Process checks : To ensure the quality of the tablets , capsules etc. the IPQA personnel shall perform in process checks like group weight , friability, disintegration , Physical appearance of compressed/coated tablets and packed blisters etc.
Sampling : Sampling activities shall be performed by IPQA person using samplers during granulation , compression and coating stages as well as control samples and samples for analysis are to be collected to ensure quality of products.
Training on GMP & GDP : IPQA personnel shall be responsible for providing training and guidance on good manufacturing practices and Good documentation practices.
Batch record review : The IPQA personnel shall be responsible for review of the batch manufacturing and packing records at every stage of manufacturing and before batch release.
Regulatory Compliance: IPQA personnel shall be responsible for ensuring all the production activities comply with regulatory requirements from agencies such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), etc.
Validation and Qualification Activities: IPQA personnel involves in validation and qualification activities . Examples like validation of equipment, processes etc . And reviewing validation protocols, executing validation studies, and ensuring that equipment and processes meet predetermined acceptance criteria.
Environmental Monitoring: Monitoring environmental conditions in Process areas and quarantine areas for temperature, humidity, to ensure they meet specified requirements for product quality and safety.
Deviation Management : Investigate any deviations or non-conformances, or out-of-specification results during production. This is done by finding the root cause analysis, initiating corrective and preventive action (CAPA) , and documentation of investigation outcomes.
These are some of the job roles and functional activities of formulation IPQA department.