IPQA 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 start a product. So the role of IPQA becomes very important at this stage. so the common point shall be followed by the IPQA officer.
Major points during line clearance:
Some of the major roles of IPQA officers during line clearance are detailed below. Ensure all points are complied with or not. If not complies then inform to respective department and raise deviation or non-compliance reports.
- Ensure the cleaned label is attached to the equipment.
- Ensure RH and Temperature are within limits as per standard.
- Is area differential pressure is within limits.
- To ensure the area is free from previous products or residue.
- Stereo (metallic or rubber) is removed or destroyed (whichever is applicable).
- Check the equipment and its parts is cleaned.
- Ensure the issuance and retrieval records of machine change parts.
- Ensure cleaning of Ceiling, filter, grill, wall, door, working table, Pallets, and glass panels.
- Is the floor area is cleaned as per the given frequency?
- Ensure Rinse or swab water sample reports is attached within documents (if applicable in the area)
- Ensure all ID on assceries and preventive maintenance status on equipment.
- Calibration and verification of balance or analytical balance.
- Ensure the cleaning of waste been.
- Ensure the proper gowning procedure is followed.
- Ensure the status board of area and product details is going to manufacture.
- Check the integrity of sieves which is going to use and their issuance records.
- Ensure the cleanness of HDPE containers
- Quality person ensure the cleaning of punches and its issuance and retrieval records.
- Ensure the use of a metal detector.
- Is area log books or annexures are filled up to the last stage,
- Ensure the BMR/BPR are completion up to the last stage.