In Process Quality Assurance (IPQA) Check Points

Standard Operating Procedure (SOP) for In – Process Quality Assurance (IPQA) check points and procedure during manufacturing of drug product in pharmaceuticals.

In process Quality Assurance (IPQA) Checks

1.0   Objective :

    • To lay down procedure for monitoring the In – Process Quality Assurance (IPQA) activities in stores and Production.

2.0   Scope :

    • The SOP is applicable in stores and production for In – Process Quality Assurance (IPQA) checks.   

3.0   Procedure – In – Process Quality Assurance (IPQA) :

    • The Office/Nominee QA shall take minimum one round in the production and stores, where activity is in progress.
  • Production – In – Process Quality Assurance (IPQA):

    • Verify the area label with the process going on in the area.
    • Verify the cleanliness of area and operation.
    • The status label verification of the equipment with process stage.
    • Verify whether the activities are carried out in accordance with relevant SOPs and instructions in BMR and BPR.
    • Verify timely completion of batch documents.
    • Personnel practices verification including gowning.
    • Verify pressure differential of areas and shall be within limits defined on the respective Magnehelic gauge.
    • The temperature and relative humidity of areas shall be in compliance with SOP No. QA-020.
    • Verify the calibration status and records of the balances.
  • RM Day Store – In – Process Quality Assurance (IPQA) checks

    • Check the entry & exit log of batch materials available in the area.
    • Temperature & relative humidity log for compliance.
    • Details of batches whose hold time exceeds 7 days and 21 Days for Oral Liquid and OSD respectively. Take comments of head of department.
  • Manufacturing (Granulation / Oral Liquid/ Lubrication) In – Process Quality Assurance (IPQA):

    • Batch documents are filled on-line and checked by production and QA wherever required.
    • Identity slips are properly enclosed in BMR.
    • Manufacturing is done following the instruction of BMR.
    • Rinse / swab reports are available in BMR.
    • Riser filters are cleaned during product change over & A type cleaning.
    • Check the temperature & humidity of the area. It should be within limit as specified.
    • The reading of Maghnelic Gauge, it should be within limit.
    • IPQC has been done and recorded wherever required.
    • Current version of SOP’s is available in the areas.
    • Equipment logs and area logs are filled on-line with sign & date.
    • Any deviation observed, has been properly reported.
    • Cleaning records are maintained.
    • Action has been taken if hold time exceeds.
    • Gowning system has been followed.
  • Compression – In Process Quality Assurance (IPQA):

    • Line clearance has been done.
    • Correct bin is placed in bin feeding area having approved status.
    • Bulk release COA is enclosed in BMR.
    • Batch documents are filled on-line and checked by production and QA wherever required.
    • Compression is done following the instruction of BMR.
    • Rinse / swab reports are available in BMR.
    • Riser filters are cleaned during product change over & A type cleaning.
    • In – Process Quality Assurance (IPQA) checks are done as per frequency defined in BMR.
    • Check the IPQC parameters and records the observations.
    • The reading of Maghnelic Gauge, it should be within limit.
    • Check the temperature & humidity of the area. It should be within limit as specified.
    • Current version of SOP’s is available in the areas.
    • Equipment logs and area logs are filled on-line with sign & date.
    • Any incident / deviation observed, has been properly reported.
    • Cleaning records are maintained.
    • Action has been taken if hold time exceeds.
    • Gowning system has been followed.
  • Capsule filling and Polishing – In Process Quality Assurance (IPQA):

    • Line clearance has been done.
    • Bulk Material, EHG capsule shells and filled capsules has proper status label.
    • Bulk release COA is enclosed in BMR if applicable.
    • Batch documents are filled on-line and checked by production and QA wherever required.
    • Capsule filling is done following the instruction of BMR.
    • Rinse / swab reports are available in BMR.
    • Riser filters are cleaned during product change over & A type cleaning.
    • In – Process Quality Assurance (IPQA) checks are done as per frequency defined in BMR.
    • The IPQC parameters and records the observations.
    • Verify the temperature & humidity of the area. It should be within limit as specified.
    • Check the reading of Maghnelic Gauge, it should be within limit.
    • Current version of SOP’s is available in the areas.
    • Equipment logs and area logs are filled on-line with sign & date.
    • Any incident / deviation observed, has been properly reported.
    • Cleaning records are maintained.
    • Gowning system has been followed.
  • Coating of tablets – In Process Quality Assurance (IPQA):

    • Line clearance has been done.
    • Coating materials as per status label and identity slips are attached in BMR.
    • Coating solution is prepared as per instruction given in BMR.
    • Uncoated tablets COA are enclosed in BMR if applicable.
    • Batch documents are filled on-line and checked by production and QA wherever required.
    • Coating process is done following the instruction of BMR.
    • Coating parameters are same as defined in BMR. Check the PLC parameters.
    • Rinse / swab reports are available in BMR.
    • Riser filters are cleaned during product change over & A type cleaning.
    • In – Process Quality Assurance (IPQA) checks are done as per frequency defined in BMR.
    • Verify the IPQC parameters and records the observations.
    • Verify the temperature & humidity of the area. It should be within limit as specified.
    • Monitor the reading of Maghnelic Gauge, it should be within limit.
    • Current version of SOP’s is available in the areas.
    • Equipment logs and area logs are filled on-line with sign & date.
    • Any incident / deviation observed, has been properly reported.
    • Cleaning records are maintained.
    • Gowning system has been followed.
  • Packing Process – In Process Quality Assurance (IPQA) :

    • Line clearance has been done.
    • Approved packing materials are placed in area and properly identified.
    • All the materials are placed on pellets.
    • QC release COA is available.
    • Rinse / swab reports are available in BMR.
    • Riser filters are cleaned during product change over & A type cleaning.
    • Process parameters are same as defined in BPR like sealing and forming temperature, machine speed etc.
    • In – Process Quality Assurance (IPQA) checks are done as per frequency defined in BMR.
    • Leak test has been performed as per frequency defined in BPR.
    • IPQC parameters and records the observations.
    • Check the stereo control register for proper entry.
    • Verify the temperature & humidity of the area. It should be within limit as specified.
    • The reading of Maghnelic Gauge, it should be within limit.
    • Approved specimen is available in BMR with sign. and dated.
    • Packing is done as per BPR.
    • Hold time of tablets / capsules is not exceed the time defined.
    • Bar coding is done, wherever required, as defined in BPR.
    • Reconciliation has been done.  
    • Check the coding details and item code on printed packing materials and will be same as per weighment sheet.
    • Current version of SOP’s is available in the areas.
    • Equipment logs and area logs are filled on-line with sign & date.
    • Cleaning records are maintained.
    • Gowning system has been followed.
  • Oral Liquid filling and sealing – In process Quality Assurance (IPQA) checks:

    • Line clearance has been done.
    • Bulk liquid, PP caps and bottles has proper status label.
    • Bulk release COA is enclosed in BMR if applicable.
    • Batch documents are filled on-line and checked by production and QA wherever required.
    • Filling and Sealing is done following the instruction of BPR.
    • Rinse / swab reports are available in BPR.
    • In – Process Quality Assurance (IPQA) checks are done as per frequency defined in BPR.
    • Monitor the temperature of the area.
    • It should be within limit as specified.
    • The reading of Maghnelic Gauge, it should be within limit.
    • Current version of SOP’s is available in the areas.
    • Equipment logs and area logs are filled on-line with sign & date.
    • Any incident / deviation observed, has been properly reported.
    • Cleaning records are maintained.
    • Gowning system has been followed.
  • Stores – In – Process Quality Assurance (IPQA) checks:

    • Quarantines – IPQA:

    •  Quarantine area properly cleaned.
    • Required current version of SOP’s are displayed.
    • Receipt materials in compliance of material receipt SOP.
    • Temperature and relative humidity maintained and records are available.
    • Proper gowning system followed in the area.
    • Ensure balances are properly placed and calibration records maintained.
    • The materials have proper quarantine label.
    • Approved vendor list available in store.
    • Any incident / deviation observed, properly reported.
    • Storage Areas– In process Quality Assurance (IPQA):

    • Materials stored as per recommended storage area.
    • The materials have proper quarantine, under test, sampled, approved or rejected labels.
    • Rejected materials placed in rejected area.
    • Daily and weekly cleaning of areas done as per defined frequency and records available.
    • Status labels are properly maintained.
    • Loose labels are correctly defined.
    • Required temperature and relative humidity is maintained.
    • Daily and weekly cleaning are done at defined frequencies. Check cleaning records.
    • Status labels affixed on containers legible.
    • Calibration of balances at done at frequency defined in SOP.
    • Bulk consignments properly identified.
    • Check the temperature monitoring record of deep freezer.
    • Dispensing area – In process Quality Assurance (IPQA):

    • Areas are clean and records maintained.
    • Gowning system followed.
    • Area smooth finished.
    • Areas, RLAF & other accessories cleanness.
    • Records of dispensing are available and maintained.
    • Check the dispensing record, cleaning records, SOP’s, gowning system etc.
    • Dispensing tools area clean.
    • RLAF, hygrometer, gauges and other monitoring devices calibrated and functional.
    • Records properly sign & dated.
    • Sampling area – In process Quality Assurance (IPQA):

    • Areas are clean and records maintained.
    • Gowning system followed.
    • Area smooth finished.
    • Ensure the cleanness of Areas, RLAF & other accessories.
    • Records of sampling available and maintained.
    • Check the dispensing record, cleaning records, SOP’s, gowning system etc.
    • Sampling tools area clean.
    • Ensure the calibration and functionality of RLAF, hygrometer, gauges and other monitoring devices.
    • Records are properly sign & dated.
    • Officer QA shall record the observation on annexure I.
    • Review the report and Inform to concern department head and QA head in case any discrepancy for corrective and preventive action.
    • Review the CAPA taken for effectiveness.  
  • The frequency of the in process quality assurance (IPQA) checks shall be done as below:

Sr.No Area In-process checks Frequency
Production In – Process Quality Assurance (IPQA)

1.

Compression

Average Weight Initially Initially
Weight of 20 Tablets Initially, After Every1/ 2 Hours &  After Every Break Initially & every 2 hours
Uniformity of Weight Initially, After Every  1 Hours and end of the process 2 hours
Hardness Initially, After Every 2 Hours and end of the process 2 hours
Thickness Initially, After Every 2 Hours and end of the process 2 hours
Friability Initially, After Every 2 Hours and end of the process 2 hours
Disintegration Initially, After Every 2 Hours and end of the process 2 hours

2.

Coating

Inlet Temp. Initially, After One Hour  and end of the process ——-
Bed Temp. Initially, After 1 Hour  and end of the process ——-
Outlet Temp. Initially, After 1 Hour and end of the process ——-
Atomizing Air Pressure Initially, After 1 Hour and end of the process ——-
Pan Negative Pressure Initially, After 1 Hour and end of the process ——-
Pan Speed( Rpm) Initially, After 1 Hour and end of the process ——-
Peristaltic Pump(Rpm) Initially, After1 Hour and end of the process ——-
Spray Rate (G/Min) Initially, After 1 Hour and end of the process ——-
Average Weight Initially, After 1 Hour and end of the process ——-
% Weight Build Up During Coating Initially, After 1 Hour and end of the process ——-

3

Capsule filling

Average fill Weight Initially, After Every1/ 2 Hours After Every Break and end of the process 2 hours
Uniformity of Weight Initially, After Every  2 Hours and end of the process 2 hours
Disintegration Initially, After Every 2 Hours and end of the process 2 hours

4

Packing

Leak Test Initially, Initial/after every roll changes of Ptd. Blister foil and PVC film/ after break hours and end of the process Every 4 hours
Coding Details Initial and after every 1 hour and end of the process 2 hours
Temperature Of Forming Roller Initial and after every 2 hour and end of the process 2 hours
Temperature Of Sealing roller Initial and after every 2 hour and end of the process 2 hours

5

Packing liquid

Volume Uniformity After every1 hour, and end of the process 2 hours
Foreign Particle After Every 1 Hour and end of the process 2 hours
Sealing After Every 1 Hour and end of the process 2 hours
Leak Test Initially And After Every 4 Hour, Major Break Down and end of the process. 4 hours

 

Janki Singh

Mrs. Janki Singh is the professional pharmaceuticals Blogger. She has already posted more than #1000 articles on varrious topics at different blogging plateforms. Contact : guideline.sop@gmail.com