SOP for Line Clearance (LC) of Area and Equipments

Standard Operating Procedure (SOP) for Line Clearance (LC) of the manufacturing area and equipment at the different stages of drug product manufacturing and packing in a pharmaceutical manufacturing plant.

Procedure for Line Clearance of Area and Equipment

1.0       PURPOSE :

    • The purpose of this SOP (Standard Operating Procedure) is to describe the procedure for clearance of line, area and equipment in production and warehouse department.

2.0      SCOPE:Line Clearance Checklist

    • This procedure is applicable to –
      • Batch to the batch changeover of area and equipment.
      • Product to product changeover of area and equipment.
    • Startup clearance for starting of new batch/product or continuation of the previous batch for the next day, at the pharmaceutical manufacturing plant.

3.0      REFERENCES:

    • In House
    • SOP for General Cleaning Procedure for Production Area.

4.0      RESPONSIBILITY:

    • Production operator and Warehouse Personnel shall be responsible for

    • Maintaining the area(s) and equipment(s) cleanliness in their respective area, as per the relevant type of cleaning as per the defined procedure,
    • So that no remnants of previous batch(s) / product(s), are left out in the area/equipment.
    • Ensure the use of proper gowning, hand gloves, nose mask and secondary gowning of the personnel working in the Primary area during line clearance (LC) and operations.
    • Production and warehouse personnel shall ensure the intactness of the connection of static charge dissipator and earthing.
    • Production and warehouse Personnel shall be responsible for taking line clearance (LC)of area and equipment for their respective area(s).
    • Maintain the activity in BMR/BPR/equipment Sequential log/Line Clearance Record and Line Clearance.
    • Intimating Quality Assurance officer for line clearance (LC) in advance for respective equipment(s) and area(s).
    • Production and warehouse Department head shall be responsible for –

    • Ensure proper implementation of the SOP. 
    • QA department / QA personnel shall be responsible for –

    • Ensure differential pressure of the respective area is within the limits and check entry of the same in the logbook.
    • QA shall ensure that temperature and relative humidity is complying as per the established limits or product requirement and check the entry of the same in the logbook and BMR/BPR/Line clearance checklist as applicable.
    • Visually ensure the cleanliness of the area/equipment (s) so that no remnants of previous batches/products, as per the type of cleaning are left out in the area/equipment (s).
    • Also, check the Qualification/Calibration and Preventive Maintenance tags for verifying the validity.

    • QA, Production and Warehouse Personnel shall follow the instructions described in the Line clearance (LC) checklist of BMR/BPR/ attached checklist sheet.
    • Ensure that calibration of the weighing balances are performed by using calibrated weight box and check the entry of the same in the logbook.
    • Ensure the gowning of the person described as per the SOP of “Entry and Exit procedure for primary area” for the intended area.
    • QA shall ensure the personnel working in the area shall wear the PPE (personal protective equipment) as per the SOP of “Entry and Exit procedure for primary area”-(BSPN/023) for the intended area.
    • Follow the additional instructions if any as per BMR/BPR during the line clearance (LC).
    • Ensure all the logbooks are filled and duly checked by warehouse / production officer / executive applicable to that particular area. QA may sign on the remark column or re-verify the entries made.

5.0      ABBREVIATIONS:

    • BMR: Batch manufacturing record
    • BOM: Bill of Material
    • BPR: Batch Packing Record
    • BQS : Blistering Quickly Through Servo
    • FBD : Fluidized Bed Dryer
    • IPQA: In-Process Quality Assurance
    • ITW : Illinouis Tool Works
    • M/C : Machine
    • DEFINITION:

    • Area Clearance: It is defined as the clearance certification for the area, to be used for the next batch/product, performed by the concerned officer and checked by QA officer before starting a new batch/product.
    • Equipment Clearance: It is defined as the clearance certification for the equipment, to be used for the next batch/product, performed by the concerned officer and checked by QA officer before starting a new batch/product.
    • Start-up Clearance: It is the checks performed by the concerned officer and checked by the QA officer before starting a new batch/product.

6.0      PROCEDURE FOR LINE CLEARANCE (AREA & EQUIPMENT):

    • General Instruction for Line Clearance:
    • Cleaning of production area shall be done as per SOP of “General Cleaning Procedure for Production area”.
    • Proper status labeling of the area shall be ensured as per SOP of “Status Labelling”.
    • Line clearance (LC) shall be given for various areas as per the procedure mentioned below for the particular area.
    • Line clearance to be performed only in the dismantled condition of equipment’s part.
    • During product change over, Production and QA shall ensure the cleanliness of the area, each major part of the equipment, change part, gasket, lids, hoppers, cabinets, brush, etc.
    • If the area conditions, documents & the required cleanliness as per the type of cleaning are satisfactory then fill the ‘Line clearance checklist’ as per the relevant Annexure-2/3/4 or respective BMR/BPR and sign along with the date in the required column(s).
    • All line clearance given is valid for 48 hours.
    • In case the area is not used after taking the line clearance for more than 48 hours, again line clearance shall be taken as per the procedure defined.
    • If any discrepancies are observed by QA during line clearance, it shall be brought to the knowledge of the concern area in-charge.
    • The activity shall be started after necessary CAPA is implemented or the observed discrepancies are rectified.
    • However, during line clearance, if the discrepancies are repeated, then an event shall be raised for the same as per the respective SOP for Incident / Deviation.
    • Line Clearance During Dispensing :

    • Warehouse personnel shall intimate QA for line clearance after segregating all the approved materials to be dispensed for a batch as per MIO and BOM.
    • QA shall verify the correctness of raw material by checking the Material name, Material grade (if applicable), Item code, A.R. Number (QC Ref. No), Mother Label on containers/ bags.
    • QA shall ensure that there is no physical damage to the container/s and is /are during the time of dispensing.
    • In case loose container/s is/are used for dispensing; the same shall bear a status label as per SOP of “Dispensing of Raw Material”.
    • In case intact container/s is/are used for dispensing; the same shall also bear a status label as per SOP of “Dispensing of Raw Material”.
    • QA shall check the area around the dispensing room and ensure the cleanliness of the scoop, RLAF, Vacuum cleaner, spatula, liquid dispenser, etc. during line clearance.
    • Warehouse personnel shall perform the dispensing activity after getting line clearance from QA.
    • Warehouse personnel shall follow the sequence to dispense the raw material as per the SOP of “Dispensing of Raw Material”.
    • Some of the critical parts (but not limited to) to be checked are shown below :

 

Line Clearance in Dispensing

    • Line Clearance During Granulation :

    • Production officer /executive shall intimate to QA officer for line clearance after ensuring the proper cleaning of area & equipment(s).
    • QA shall check the area and equipment cleanliness.
    • All the equipment shall be labeled as “CLEANED “at the time of line clearance.
    • QA shall ensure the completeness of BMR up to the previous stage.
    • QA shall verify the weight of API(s) after the line clearance.
    • After satisfactory checking, QA shall provide the line clearance and sign the BMR.
    • The production officer/executive shall start the manufacturing activity after getting line clearance from QA.
    • Checkpoints: Some Photos of Difficult to Clean Parts (but not limited to) in Granulation are shown below :
    • Sifting/milling & dry milling stage:

Line Clearance - Granulation

      • Comminuting Mill: Feeding Augar & Hopper, Blade & Screen 
      • Paste Preparation Cattle:
      • Paste Cattle Stirrer:
    • Mixing & Granulation Stage:
      • RMG: Impeller,
      • The inner wall of the lid,
      • Feeding chute,
      • CO- Mill,
      • RMG Chopper,
      • Discharge Chute,
      • RMG Discharge Chute of CO-MILL,
      • Scrapper.
    • Drying Stage :
      • FBD Trolley & Sampling Port
      • FBD – Dutch mesh of Trolley
      • Bottom of Plenum
      • View glass in Retarding chamber
      • Outside view
      • Tray Dryer: Outside view, Inner View, Tray
    • Roll Compactor :
      • Compactor Screen
      • Feeding Augar
      • Compaction Roller
    • Line Clearance During Blending :

    • Production officer /executive shall intimate to QA officer for line clearance after ensuring the proper cleaning of area & equipment(s).
    • QA shall verify the cleanliness of the bunker to be used for blending purposes.
    • The bunker shall be labeled as “CLEANED” at the time of LC.
    • QA shall ensure the completeness of BMR up to the previous stage.
    • After satisfactory reviewing of documents, logbooks, and area, QA shall provide the LC and sign the BMR.
    • Production and QA shall verify the unique container no., cable tie no., gross weight, tare weight and net weight with respect to BMR.
    • Production officer/executive shall start blending activity after getting line clearance from QA.
    • Ensure that the weights of the containers/bins are recorded accurately in the respective BMR.
    • CheckPoints: Mentioned the difficult to clean parts (but not limited to) of Bunker :
      • Bunker: Lid Inner Surface
      • Bunker: Inner walls
      • MTS: Material Transfer System
      • MTS – Feeder:
    • Line clearance during compression :

    • Production officer /executive shall intimate to QA officer for line clearance after ensuring the proper cleaning of area & equipment(s).
    • QA shall verify the cleanliness of the area and equipment to be used for compression.
    • Ensure the completeness of BMR up to the previous stage.
    • QA shall ensure that the correct containers are being issued from the quarantine area for compression.
    • Production and QA shall verify the unique container no., cable tie no., gross weight, tare weight and net weight of containers with respect to BMR.
    • QA shall follow the additional instructions if any as per the BMR to provide the LC.
    • After ensuring all the checkpoints, QA shall sign the BMR for LC.
    • After getting LC, the production officer/ executive shall bring the containers to the compression area.
    • The production officer/executive shall ensure the correct set of punch is being issued for the batch and its issuance details and verified by QA.
    • The production officer/executive shall start compression activity after getting LC from QA.
    • CheckPoints: Mentioned below the difficult to clean parts (but not limited to) of Compression machine:
      • Compression M/C – Turret
      • Hopper
      • Feed Frame
      • Discharge chute 
      • Force Feeder
      • Turret with Punch
      • Inside M/C guard
      • De-Duster
      • Vibrator
      • Metal Detector
      • Scoop
      • SS Perforated Bowl
    • Line Clearance During Encapsulation :

    • Production officer /executive shall intimate to QA officer for line clearance after ensuring the proper cleaning of area & equipment(s).
    • QA shall verify the cleanliness of the area and equipment to be used for the activity.
    • Ensure the completeness of BMR up to the previous stage.
    • QA shall follow the additional instructions, if any, as per BMR to provide the line clearance.
    • QA shall sign the BMR for LC.
    • The technical staff of the Production department shall ensure that the correct set of change parts are being issued for the batch by verifying the respective change parts issuance record.
    • The production officer/executive shall ensure that the correct containers/bins are being issued from the quarantine area for encapsulation.
    • The production officer/executive shall start encapsulation activity after getting LC from QA.
    • CheckPoints: Mentioned below the difficult to clean parts (but not limited to) of Capsule machine:
      • Hopper
      • Empty Capsule Sorter Elevator
      • De Dusting & Polishing Unit
      • De-Dusting & Polishing Brush
      • Capsule: Mini Capsule shorter
      • Empty Capsule Shorter
      • Mini Capsule shorter
      • Air Displacement Unit
      • Capsule feeding magazine
    • Line Clearance During Coating :

    • Production officer /executive shall intimate to QA officer for LC after ensuring the proper cleaning of area & equipment(s).
    • Production officer/executive shall intimate QA person for LC.
    • QA shall verify the cleanliness of the area and equipment to be used for coating.
    • Ensure the completeness of BMR up to the previous stage.
    • QA shall follow the additional instructions, if any, as per BMR to provide the LC.
    • Sign the BMR for LC.
    • QA shall check that the core tablets and containers are correct with respect to the batch number and lot number before issuance from the quarantine area for coating.
    • The production officer/executive shall start a coating activity after getting LC from QA.
    • CheckPoints: Difficult to clean parts (but not limited to) are depicted below:
      • Coating Machine
      • Perforated Coating Pan
      • Coating Pan Baffles
      • Nozzle Spray Gun
      • Suspension Tank with Stirrer
      • Colloidal Mill
      • Colloidal Mill inner View
    • Line Clearance During Inspection of Tablets and Capsules :

    • Production officer/executive shall intimate QA person for line clearance.
    • QA shall verify the cleanliness of the area and equipment to be used for inspection.
    • QA shall ensure the completeness of BMR up to the previous stage.
    • Follow the additional instructions if any as per BMR to provide the line clearance.
    • QA shall ensure that the correct containers are being issued for inspection.
    • QA shall sign the BMR for line clearance.
    • The production officer/executive shall start inspection activity after getting line clearance from QA.
    • Line clearance during primary packing :

    • Production officer /executive shall intimate to QA officer for line clearance after ensuring the proper cleaning of area & equipment(s).
    • QA shall verify the cleanliness of the equipment and area.
    • Ensure the completeness of BMR up to the previous stage.
    • QA shall follow the additional instruction, if any, as per BPR to provide the line clearance.
    • Production and QA shall ensure that all the packing materials are correct and approved by QC before the start of the operation.
    • QA shall sign the Annexure-2 or BPR for line clearance.
    • Production and QA shall verify that the correct batch number and product are being issued from the manufacturing quarantine area to the primary parking area.
    • The production officer/executive shall start the packing activity after getting LC from QA in the BPR.
    • CheckPoints: Difficult to clean parts (but not limited to) during Primary packing is depicted below:
      • Blister M/C: Hopper
      • Linear Vibrating Plate & Channel
      • Channel & Guide Track
      • Rotary Vibrating plate
      • Feeding Box
      • Blister Feeding Brush with the Guide track
      • Defoiler Machine
      • BQS : Cavity Forming Plate
      • Sealing Plate
      • Indexing Station
      • BQS Machine
      • Strip Machine: Feeding Channel
      • Strip Defoiling Machine
      • Tablets / Capsules Inspection Tray
      • Strip Machine: Collator – 01
      • Strip Machine: Collator-02
    • Line clearance during Secondary packing :

    • Production officer/executive must ensure that the area and equipment are ready for Line Clearance (For secondary area) as per Annexure-4 or as per BPR.
    • Production officer/executive shall intimate QA person for line clearance.
    • QA shall verify the cleanliness of the equipment and area.
    • Ensure the completeness of BPR up to the previous stage.
    • QA shall follow the additional instruction if any as per BPR to provide the line clearance.
    • QA shall verify & ensure the correct recipe of show box coding machine.
    • Production and QA shall ensure that all the packing materials are correct and approved by QC before the start of the operation.
    • QA shall sign the Annexure-4 or BPR for line clearance.
    • The production officer/executive shall start the packing activity after getting line clearance from QA.
    • CheckPoints: (but not limited to) during secondary packing is depicted below:
      • Conveyor Belt
      • Check Weigher
      • Parle Machine: For Mono carton Packing
      • Auto Cartonator Machine
      • Check weigher with the lid open
      • Shipper Sealing Machine
    • Line clearance during Offline-Secondary packing :

    • Production officer/executive must ensure that the area and equipment are ready for Line Clearance (For secondary area) as per Annexure-4 or as per BPR.
    • Production officer/executive shall intimate QA person for line clearance.
    • QA shall verify the cleanliness of the equipment and area.
    • Ensure the completeness of BPR up to the previous stage
    • QA shall follow the additional instructions, if any, as per BPR to provide the line clearance.
    • Production and QA shall ensure that all the packing materials are correct and approved by QC before the start of the operation.
    • QA shall verify & ensure the correct recipe of show box coding machine.
    • Sign the Annexure-4 or BPR for line clearance.
    • QA shall verify that the correct batch number and product are being issued from the manufacturing quarantine area to the primary packaging area.
    • The production officer/executive shall start the packing activity after getting line clearance from QA in the BPR.
    • Line Clearance During Off-Line Coding, Labelling :

    • Production officer/executive must ensure that the area and equipment are ready for Line Clearance (for the secondary area) as per Annexure-4 or as per BPR.
    • Production officer/executive shall intimate QA person for line clearance.
    • QA shall verify the cleanliness of the equipment and area.
    • Ensure the completeness of BPR up to the previous stage.
    • QA shall follow the additional instruction, if any, as per BPR to provide the line clearance.
    • Ensure that all the packing materials are correct and approved by QC before the start of the operation.
    • QA shall sign the Annexure-4 or BPR for line clearance.
    • QA shall verify that the correct batch number and product are being issued from the manufacturing quarantine area to the primary packaging area.
    • The production officer/executive shall start the packing activity after getting line clearance from QA in the BPR.
    • Line Clearance during Bottle Filling (Primary Area) :

    • Production officer/executive must ensure that the area and equipment are ready for Line Clearance (For bottle filling) as per Annexure-2 or as per BPR.
    • Production officer/executive shall intimate QA person for LC.
    • QA shall ensure the completeness of BMR up to the previous stage.
    • Then check the cleanliness of the area and various equipment/components like unscrambling chamber, air-jet cleaning apparatus, turntable, Header 1 & Header 2, PIB (material transfer system), hose pipe, capping machine, torque machine, etc.
    • QA shall follow the additional instruction, if any, as per BPR to provide the LC.
    • Ensure that all the packing materials are correct and approved by QC before the start of the operation.
    • QA shall sign the Annexure-2 or BPR for LC.
    • Once the line clearance is taken, the setting of the machine can be done.
    • QA shall verify that the correct batch number and product are being issued from the manufacturing quarantine area to the primary packaging area.
    • The production officer/executive shall start the packing activity after getting line clearance from QA in the BPR.
    • CheckPoints: Difficult to clean parts (but not limited to) during Primary Bottle packing is depicted below:

      • Bottle : Air Jet Bottle Cleaning
      • Dry Filling M/C
      • Dosing Hopper
      • Hopper inner view
      • Dosing Hopper
      • Cap Feeder
      • Cap Feeder inner view
      • Re-torquer
      • Hosepipe
      • Bottle: Conveyor Belt
    • Line Clearance during Bottle Filling (Secondary Area) :

    • Production officer/executive must ensure that the area and equipment are ready for Line Clearance (For secondary area) as per Annexure-4 or as per BPR.
    • Production officer/executive shall intimate QA person for LC.
    • QA shall verify the cleanliness of the area and various equipment/components like induction sealing machine, re-torquer, turntable, check-weigher, ITW, etc.
    • Follow the additional instructions, if any, as per BPR to provide the LC.
    • QA shall sign the Annexure-4 or BPR for line clearance.
    • Production and QA shall ensure that all the packing materials to be used in the secondary area are correct and approved by QC before the start of the operation.
    • The production officer/executive shall start the packing activity after getting line clearance from QA in the BPR.
      • Bottle-11: Cap liner sensor
      • Induction Sealing M/C
      • Round table
      • Bottle re-torquer
      • Check Weigher
    • Line Clearance during Sachet Filling (Primary Area) :

    • Production officer/executive must ensure that the area and equipment are ready for Line Clearance (For sachet filling) as per Annexure-2 or as per BPR.
    • Production officer/executive shall intimate QA person for LC.
    • QA shall ensure the completeness of BMR up to the previous stage.
    • Then check the cleanliness of the area and various equipment/components like a hopper, lid, collar assembly, powder tube, etc.
    • QA shall follow the additional instruction, if any, as per BPR to provide the LC.
    • Ensure the correctness of all the packing materials and approved by QC before the start of the operation.
    • QA shall sign the Annexure-2 or BPR for LC.
    • Once the line clearance is taken, Do the setting of the machine.
    • Production and QA shall verify that the correct batch number and product issued from the manufacturing quarantine area to the primary parking area.
    • The production officer/executive shall start the packing activity after getting line clearance from QA.
      • Sachet-01: Hopper
      • Sachet Machine
      • Conveyor Belt
    • Line Clearance during Sachet Filling (Secondary Area) :

    • Production officer/executive must ensure that the area and equipment are ready for Line Clearance (For secondary area) as per Annexure-4 or as per BPR.
    • Production officer/executive shall intimate QA person for LC.
    • QA shall verify the cleanliness of the area and equipment.
    • QA shall follow the additional instructions, if any, as per BPR to provide the LC.
    • Sign the Annexure-4 or BPR for line clearance.
    • QA shall ensure that all the packing materials to be used in secondary area are correct and approved by QC before start of the operation.
    • The production officer/executive shall start the packing activity after getting LC from QA in the BPR.

Note: Difficult to clean equipment part “Template” shall be displayed at each room with photos of items.

    • Issuance and Filling Procedure of Logbook:

    • User Dept. Shall request for new area and equipment usage logbook in advance and before completion of previous logbook.
    • User Dept. shall fill the details in request form and handover to QA for issuance of the logbook.
    • QA shall issue the new logbook after receiving the request form.
    • Once a new logbook is issued, the User Dept. shall use the newly issued logbook from the same date onwards.
    • User shall put NA in the blank pages/spaces, (if any), in the previous logbook and return the same to QA.
    • User Dept. shall use appropriate activity code in the activity column. Activity Code :

      •                  Type A cleaning                                         – A
      •                  Type B cleaning                                         – B
      •                  Routine Cleaning                                       – R
      •                  Process                                                       – P
      •                  Maintenance                                               – M
      •                  Preventive Maintenance                             – PM
      •                  Fumigation                                                 – F
      •                  Break down                                                – BD
      •                  Qualification                                              – Q
      •                  Continued                                                  – CNTD
    • User Dept. shall put activity code ‘A’ in the activity code column of logbook if area and equipment cleaning to be done for the batch to batch.
    • User Dept. shall put activity code ‘B’ in the activity code column of logbook if area and equipment cleaning to be done for product to product.
    • Put activity code ‘R’ in the activity code column of logbook if area and equipment cleaning to be done for routine cleaning before starting the continued activity.
    • User Dept. shall put activity code  ‘M’ in the activity code column of logbook if area and/or equipment are under maintenance.
    • User Dept. shall put activity code ‘PM’ in the activity code column of logbook if the equipment is under preventive maintenance.
    • Put activity code ‘Q’ in the activity code column of logbook if area and/or equipment are under qualification.
    • User Dept. shall put activity code ‘BD’ in the activity code column of logbook if the equipment is under break down.
    • User Dept. shall put activity code ‘F’ in the activity code column of logbook if the area is under fumigation.
    • Put NA if any column is not applicable for that activity in the logbook.
    • User Dept. shall put an appropriate remark in remark column like Batch over, Batch Continue, Routine Cleaning in the logbook (Annexure 5).
    • Conditional Line Clearance:

    • Provide the conditional LC at the packing stage at the activities like capsule filling, coating or compression completed up to the required stages.
    • Take the temporary change / planned deviation procedure for the same.
    • If any discrepancy is observed at capsule filling, coating or compression stage. Do not allow the conditional LC at the packing stage.
    • The transferring department shall raise the temporary change / planned deviation.
    • Transfering department shall fill the details and forward the filled deviation IPQA for verification of required information as per Annexure 3 of SOP Incidents / Deviations.
    • After satisfactory review of deviation for conditional LC by IPQA, IPQA shall forward the deviation for final approval to Head QA/ Quality Head/Designee.
    • During conditional LC at the packing stage, BMR shall remain with the manufacturing department.
    • LC shall be given at the packing stage after ensuring the approval of the planned deviation.

    • Approved planned deviation shall be attached with respective BPR.
    • One photocopy of approved planned deviation for conditional LC shall also attache with BMR.
    • During conditional LC at the packing stage, IPQA shall ensure details like Batch number, Lot number, number of containers, and quantity transferred for packing against approved planned deviation.
    • Record the number of shipper packed against the approved planned deviation sin BMR/BPR history sheet or the footer part of the BPR of corresponding pages to capture such type of details with a remark.
    • After completion of all processes at the manufacturing stage, Transfer the remaining quantity/lots to packing department for the completion of the batch packing activity.
    • Take the second-time LC at the packing stage only in the Primary area to ensure the correctness of the product and remaining transferred quantity from the manufacturing department.
    • Document the re-line clearance shall be documented as per LC checklist (Annexure2).
    • Inline clearance check, put NA for the column which is not relevant with respect to second-time line clearance against conditional line clearance.

                 e.g. Put “NA” against the checkpoints like previous product.

Note 1:  Second time LC shall be ensured with respect to product and the remaining quantity of the same batch shall be packed.

    • During Re-line clearance, QA shall verify Product Name, Batch Number, Lot Number and Number of containers for packing of the remaining quantity of the batch.

Note: If the line is to be for any other product, a complete changeover and follow the line clearance procedure.

 

7.0       ANNEXURES / CHECKLIST  – SOP FOR LINE CLEARANCE :

Annexure 1: Area and Equipment Usage Log.

Department:   Area:

 

Tabulate the following table contents to make the logbook with the above header…

    • Date
    • Equipment Name
    • Equipment ID
    • Product Name
    • Batch No.
    • Shift
    • Activity Code
    • Activity
    • Done By
    • Checked By
    • Remark


Annexure 2: Line Clearance Checklist.

Previous Product: Next Product:
Previous Batch No Next Batch No.:
 

Area :              _____Stage:                                      Date :  ___________

Sr. No Check Points Checked By
Prod. QA
1 Area Clearance :
1.1 Ensure that the area should be cleaned.  
1.2 Ensure cleaning of the area underneath the equipment, (if applicable)    
1.3 Ensure that the previous product is removed from the area.    
1.4 Ensure that the waste bin has been cleaned and the fresh polybag has been put into the bin.    
1.5 Ensure the floor is mopped with a sanitizing agent.    
1.6 Ensure proper status labels on the area and absence of BOPP tape on equipment and area.    
1.7 Ensure the cleanliness of the drain point in the area. (If applicable)    
1.8 Ensure cleaning and proper status labeling of pallets / Containers, rejection bin and their availability with lid.    
1.9 Ensure cleaning of riser filters/return riser, grills.    
1.10 Ensure cleaning of walls, light fixtures, balance, and its cable, Electrical panel, SOP stand, Magnehelic gauge, Thermo hygrometer.    
1.11 Ensure that the area is within the cleaning validity period.    
1.12 Ensure cleaning of utility pendant/dust collector.    
1.13 Ensure proper gowning procedure/PPE.    

 

2

Equipment’s / Accessory Clearance :

2.1 Ensure cleaning of the equipment with the proper status label.    
2.2 Ensure traces analysis results are within the limits & record are attached with the BMR (If applicable)    
2.3 Ensure that the equipment is within the cleaning validity period.    
2.4 Ensure the equipment qualification tag is updated.    
2.5 The equipment preventive maintenance tag is updated.    
2.6 Ensure cleaning of balances used in the area (If applicable).    
2.7 Ensure that dismantle parts (i.e. Gasket, lids, hopper, flooding brush, etc.) of the machine, safety guards and earthing points are adequately acceptable and cleaned.    
2.8 Ensure that accessories to be used are cleaned and the presence of screw, bolts, and nuts on each equipment, HEPA grills and return riser.    
2.9 Ensure cleanliness of hopper and their lid.    

 

3

Environmental Conditions:

3.1 Ensure that the temperature & relative humidity of the area are with in the limit.    
3.2 Ensure that the pressure differential across the area is within limits.    

 

4

Document Review :

4.1 Ensure that the document of the previous product/label is removed from the area.    
4.2 Ensure the area & equipment log are available.    
4.3 Ensure the punch issuance record is updated.(If applicable)    
4.4 Ensure balance calibration / daily performance/calibration label is updated & check record for the same. (If applicable)    
4.5 Ensure all relevant SOP are placed in the area.    
4.6 Ensure that relevant entries are recorded in the BMR/BPR.    

 

5 Material / Product Verification of Proposed Run:
5.1 Line clearance has been given for bulk manufactured of the proposed run    
5.2 The correctness of material/product name & A.R. No./ batch number.    
5.3 The product is stored as per the established hold time conditions & limits.    
Production Officer Name: Sign: Date:
IPQA Officer Name: Sign: Date:
Note : Put (√ ) for complies / ( X ) for not complies/ ( NA ) for not applicable in column given

 

Annexure 3: Line Clearance Checklist for Dispensing.

Area : Date :
Previous Product : Next Product :
Batch Number : Batch Number :
Sr. No. Description of Activity *Observation

Warehouse

*Observation

QA

1 Ensure the cleanliness of the dispensing area.
2 Ensure the proper status label on the RLAF.
3 Ensure the removal of all materials of previously dispensed product/ batch from the area.
4 Ensure the removal of all the documents and containers of the previous product.
5 Ensure the clean and calibrated weighing balance as per respective SOP.
6 Visually check the RLAF for its Cleanliness.
7 Ensure that environmental conditions are maintained and recorded as per BMR/BPR.
8 Ensure that the pressure differential of area and RLAF within the limit and recorded.
9 Ensure that the RLAF started before 20 minutes from starting the dispensing.
10 Ensure the cleanliness of return air riser filters in the area.
11 Ensure the equipment qualification tag updated.
12 Ensure that the SOP of cleaning and operation of equipment in place.
13 Visually check the waste bin for its cleanliness.
14 Ensure that the bar code scanner presence in the area.
15 A list of light-sensitive material, nitrogen flushing, and psychotropic material are present in the area.
16 Ensure the proper gowning procedure followed by persons
17 Verify the details on material issue coupons with unconfirmed MRO.
Checked By Store

Sign/Date

QA

Sign/Date

*Put (√ ) for complies/ ( X ) for not complies/ ( NA ) for not applicable in observation column.

 

Annexure 4: Line Clearance Checklist for Secondary Packing.

Previous Product: Next Product:
Previous Batch No.: Next Batch No.:
Line No.:                                                             Date :
Sr. No Check Points Checked By
Prod. QA
1 Area Clearance :
1.1 Ensure the area cleanliness.  
1.2 Ensure the floor is mopping with a sanitizing agent    
1.3 Check the top and below of the conveyor and ensure the absence of remnants of the previous product.    
1.4 Ensure the cleanliness of the waste bin and fresh polybag placed into the bin.    
1.5 Check that the line status board for updated information.    
1.6 Check the non-recovery of the previous batch destroyed.    
1.7 Ensure cleaning of Pallets, Containers/Rejection bin.    
1.8 Ensure proper gowning procedure.    

 

2

Equipment / Accessory Clearance :

2.1 Ensure that the cleaned balances used in the area.    
2.2 Ensure that the cleaned accessories used in the area.    
2.3 Check that mini touch over the coding machine (Condot / HSA Jet / Concept). It should clear from the data/recipe of the previous product and remove the stereos.    
2.4 Ensure that the cartridge of the carton coding machine of the previous batch. Removed and replaced with the new cartridge.    

 

3 Environmental Conditions:
3.1 Ensure that the pressure differential across the area is within limits    

 

4 Document Review :
4.1 Ensure that the area & equipment log is available and filled properly.    
4.2 Ensure that the balance calibration / daily performance/calibration label is updated & check record for the same. (If applicable)    
4.3 Check that the reconciliation of the previously completed batch.    
4.4 Ensure that all relevant SOP placed in the area.    
4.5 Ensure those relevant entries recorded in the BPR.    

 

5

Material / Product Verification of Proposed Run:

5.1 The correctness of material/product name & A.R. No./ batch number.    
Production

Officer

Name: Sign: Date:
IPQA Officer Name: Sign: Date:
Note : Put (√ ) for complies / ( X ) for not complies/ ( NA ) for not applicable in column given

 

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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