Role of IPQA person in pharma industry
In this article we will know about role of IPQA person in Pharma industry.
List of role of IPQA person in Pharma company:
line clearance activities at all stage.
Sampling and inspects samples as required.
Performs in-process whenever required.
Performs challenge test whenever required.
Reviews, audits, and monitors the processes.
To check the on going Process as per BMR and BPR.
IPQA person to perform IPQA activities at shop floor in each and every stage.
The role of IPQA person in review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release.
IPQA person also play important role in pharma company as a IPQA.
IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities.
• Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records.
• Preparation & Review of process validation protocols and reports.
Executing the validation/revalidation activity in the absence of authorized person.
• Any job activity assigned by HOD
• Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA.
Following role of IPQA executive in pharma industry or company.
Execute IPQA Excellence by setting clear benchmarks.
• Smart Thinker and displays smart/ tactical moves & mental agility.
• Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past.
• Comes up with ideas which are different and can be used commercially, profitably and growth.
• Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas.
• Proposes solution which has elements of sustainability.
The IPQA person role in Dispensing in pharma industry.
The IPQA person giving line clearance in dispensing area and during line clearance of dispensing area that time IPQA person play important role in Pharma industry IPQA person check all previous material and documents are clear at the time of line clearance for next dispensing activity to avoid the mix-up and contamination one material with another so role of IPQA person in Pharma industry very important.
The IPQA person role decided by manager in Pharma industry.
IPQA manager assign the role of IPQA and prepare the list of role of IPQA person according that IPQA person perform there role in Pharma industry at shop floor.
Following below mentioned role perform by IPQA person:
IPQA person giving line clearance in dispensing,granulation, compression, coating, inspection aera,capsule filling aera,powder filling aera and in manufacturing and packaging aera.
In the granulation area IPQA check the check points during line clearance in granulation area as per mentioned in the line clearance check list IPQA person check one by one check points such as differential pressure, status board of the aera, cleaning of the area, calibration status of the area and preventive maintenance of equipments like rapid mixer granulator, blender, comill,shifter.
IPQA person also check and ensure the cleaning of granulation area such as floor, wall, doors,coawing etc.
IPQA person perform line clearance in compression area and role of IPQA person:
IPQA perform in-process, line clearance, collect sample such as finished sample, stratified sample,speed challenge sample, continues process verification sample.
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