IPQA Full Form in Pharmaceutical Industry | SOP For IPQA

IPQA full form:- In-Process Quality Assurance / Institutional Planning and Quality Assurance. In-process Quality Assurance  (IPQA) and In-process quality control responsibilities.

1.0 OBJECTIVE

1.1 To provide a Written procedure for the Chemist about the job to be performed in IPQA.

2.0 SCOPE

2.1 This procedure is applicable to Quality Assurance Deptt. of XZY

3.0 RESPONSIBILITIES

3.1 QC Chemists Lab analyst follows the SOP.

3.2 Head- QA & QC for implementation of SOP.

4.0 PROCEDURE

IPQA Activities for Toilet Soap Plant :

 4.1 Online physical appearance inspection of soaps of all finishing lines as per the current defect classification.

4.2 Cavity-wise weight checking of all finishing lines.

4.3 Check the moisture content of all finishing lines.

4.4 Perform the Grit test & Dry Crack test of all the running lines.

4.5 Check the integrity of to be used & used sieve in Duplex plodder & record the condition of the sieve on sieve change format. Perform sieve change activity as per Specification.

4.6 Check the Performance of Metal Detector with prescribed Standard Reference sample and Record on  Metal Detector Check format. To check the performance of Metal Detector as per Specification.

4.6 Check the Performance of air and check all Machines' temperatures as per Required Specification.

4.7 Check the soap wrapping ok, not ok, and Check, to Assure Batch Coding ok in the Wrapping Stage. Batch Coding approved with IPQA Chemist, Production In-charge & QC In charge.

4.7 Check that all Activities in the soap plant are to be carried out at a Frequency of 2hours.

4.8 Relevant Documents are to be maintained for all the Activities.

 5.0 Weighing & Recording of filled Shipper Weight.

5.1 Production Soap plant will do the online Weighing of the filled shipper and Record the weight of the shipper on a Weight Record sheet.

5.2 Production Operator will review the data after 50 Boxes.

5.3 Production supervisor & IPQA Chemist will also verify the Weight Record data After 2 hours each line.

5.4 Production Operator/supervisor/IPQA Chemist found any shipper weight out of trend then production will check the 100% in the shipper presence of IPQA Chemist for its weight correctness.

5.5 Check the Batch coding in Outer Box & Batch Coding approved with IPQA Chemist, Production In-charge & QC In charge.

5.6 Maintain the Record on Weight Record Sheet with correction done along with IPQA & Production signature.

6.0 FG Control Sample & Testing

6.1 Collect one Soap Sample per 1Hours Production total of 8 Samples per shift for FG Testing & 2 samples kept as retained Samples.

6.2 All retain Sample Preserved for Date of Expire.

7.1 Defect shell be defined as non-fulfillment of an intended usage Requirement.

7.2 Defects may be classified broadly into three categories:-

Definition of critical, major, and minor defects.

Critical: 

Any non-compliances with Legal or Statutory Requirements or Customer Safety, Readily. Recognized by consumer/Trend if any Observed in the Soap, would Probably Involve Refused to Purchase.

Major: 

Three are 50:50 Chances of the Product being Purchased by the Costumer or hesitate to Purchase, if immediately Recognized or Discovered Later.

Minor: 

Not Recognized by the Customer as a defect but the Presence of a Large Number could give rise to a less Favorable Impression. 

8.0 ABBREVIATION

SOP:     Standard Operating Procedure

QA:     Quality Assurance

QC:     Quality Control

CM:    Centimeter

9.0 REFERENCE:

IN-HOUSE

Fitter job description 

BANTI SINGH

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