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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 status label where relevant.

• • 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.

• • Check the balance calibration records for compliance.

• • 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):

• • Line clearance has been done.

• • 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.

• • Any incident / deviation observed, has been properly reported.

• • 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: