Role of IPQA during Line Clearance

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.

Role of IPQA during Line Clearance

The line clearance stage is the very crucial stage before starting a product. So the role of the IPQA Officer becomes very important at this stage. Below is some common point that 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 that all points below are complied with or not. If not comply, 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 within limits?
  • 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 are 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 cleaned as per the given frequency?
  • Ensure Rinse or swab water sample reports comply and are attached to documents (if applicable in the area).
  • Ensure all ID on accessories and preventive maintenance status on equipment.
  • Calibration and verification of balance or analytical balance.
  • Ensure the cleaning of the waste Bin.
  • Ensure the proper gowning procedure/ PPE is followed.
  • Ensure the status board of area and product details are going to manufacture.
  • Check the integrity of the sieves which is going to use and their issuance records.
  • Ensure the cleanness of HDPE containers
  • Quality persons ensure the cleaning of punches and their issuance and retrieval records.
  • Ensure the use of a metal detector.
  • Is area log books or annexures filled up to the last stage?
  • Ensure the BMR/BPR is completed up to the last stage.

Related: Line Clearance Checklist point production/packing

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