Production

Induction Sealing Machine, Purpose :

Induction Sealing Machine, The purpose of this SOP is to describe the Set up, operation, and cleaning of Induction Sealing Machine (Model: IND-130HC ) in the Dialysis Fluid Unit  of XX Pharmaceuticals Limited.

Induction Sealing Machine, Scope :

This SOP is applicable for the Production and Primary Packaging of Dialysis Fluid Unit XX Pharmaceuticals Limited.

Definition / Abbreviation :

[][]SOP: Standard Operating Procedure.
[][]Induction Sealing: Non-contact method of eddy (electromagnetic current) heating to a metallic disk that accomplishes the hermetic sealing.

Responsibilities :

[][]The Roles and Responsibilities are as follows :

Operator

[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.

Executive, Production

[][]To monitor and check the laid down procedure.

Manager, Production

[][]To implement this correctly.

Head of Quality Assurance

[][]To approve the Document.

Annexure

Annexure-I: Operation Logbook of Induction Sealing Machine ( Model: IND-130HC )

Precautions :

[][]Never unscrew the Sealing Head valves of the handle.
[][]Have the meter serviced only by the Mettler Toledo service.
[][]Any spillage should be wiped off immediately some solvents might cause corrosion of the housing.
[][]Avoid the following environment influences:
[][]Powerful vibrations

Operation:

[][]Ensure that working area is clean.
[][]Switch on the power its main.
[][]Power on the Sealing Machine.

Set the Sealing Temperature and Time.

[][]Check the Time 0.8 sec and temperature 250° c.
[][]Placed the Aluminium Sealing Foil top of the Container (Filing Mouth).
[][]Sealed the Cap (HDPE) With Aluminium Sealing Foil.
[][]For Induction Sealing, Press wait until a stable endpoint (0.8 sec) has been reached.
[][]Hear the “beep” sound.
[][]See the sign (Blue Light) at the Front side of the display.
[][]Put Off the Induction Sealer and then Transfer the Sealed Container.
[][]Collect the Filled Container For Next Sealing.
[][]Press OFF if any Emergency Problem Arises.
[][]Record the Sealing data in the Operation Logbook of Sealing Machine (Model: IND-130HC) as per Annexure-I.
[][]Power off the Sealing Machine.
[][]Switch off the power from its main.

Cleaning and maintenance:

[][]Wipe the Induction Sealing Machine with dry cloth.
[][]The Body of the instrument may attack by KDF Solution.
[][]Wipe away any spillage immediately.

Domino, Purpose:

Domino, To lay down the procedure for operation of ink jet printer (Domino A-Series A-220 GP Printer) in order to comply with cGMP at the Packaging area.

Domino, Scope:

This SOP is applicable for the Packaging Area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows :

Operator

[][]To follow the laid down procedure

Executive, Packaging

[][]To monitor and check the procedure is followed

Manager, Production

[][]To implement this correctly

Head of Plant Operation

[][]To agreed this SOP

Head of Quality Assurance

[][]To approve the SOP

Procedure :

Precaution:

[][]The working person must follow the safety procedures of work.
[][]For any trouble put OFF the main switch first and protect Materials.
[][]Check electric connection and mechanical set up.

Machine Operation

[][]All Operations of machine are controlled by the following different keys/buttons. There are two types of buttons.
[][]Permanent buttons with fixed functions.
[][]Function buttons (soft keys) with functions that change.
[][]To Machine start –up from Power off, Press & hold the Power on/off button for 2 sec.
[][]The green indicator on the power button is lit.LED begins to flash
[][]The status bar at the top will display any faults if got.
[][]The Home screen will display. Icon will show at top right corner.
[][]Press & hold the Jet start/stop button for 2-3 sec.
[][]The green indicator on the start/stop button begins to flash.
[][]The status bar displays faults or jet starting.
[][]The start-up takes approximate 70 sec.
[][]The status indication shows “Start”
[][]The printer is now ready to print message. Icon will show up at top right corner.
[][]To Machine Shut-Down from ready to print or standby, Press the Power on/off button for 2 sec.
[][]The green indicators on the Jet start/stop button & power on/off button begins to flash
[][]A timer is shown on the bottom right screen & display

To write new message from the Home Screen:-

[][]Press the “Message” button.
[][]Press the “New” button.
[][]Enter a “Name” for the message & press “Enter”
[][]Ensure the “Message settings”.
[][]Press “Add field” button.
[][]Select “Text” by cursor button & press “Enter”.
[][]Press “Add field” for 2nd portion & select “User defined”.
[][]Write date or Numbers.
[][]Repeat same procedure for “New” & “Enter” lines.
[][]Once the message is complete, press “Enter”.
[][]Save this message & press “Enter” again to return to main screen.
[][]To print the messages press the “Start Print” button.

To edit message saved in the message store:-

[][]Press “Edit” button .Message settings are highlighted.
[][]Use the keyboard to select the parameters wish to change.”W” for width.
[][]Press “Next Field” one of the message fields will be highlighted
[][]If required press “Next Field” again until the required field is highlighted.
[][]Change the Field settings.
[][]Press the “Edit Text” button. The message text can then be edited.
[][]Press the “Enter” button to “Save as”.

To print Message from the Home screen :-

[][]Press the “Message button”
[][]Use the cursor buttons to move up & down to high light the message to be printed.
[][]Press the “Start Print”.

To Print adjust any print parameters:-

[][]Press “Print adjusts”. When pressed you will see the screen.
[][]Press the relative character to adjust the options.

To insert LOGO from Home Screen:-

[][]Press the “Message” button.
[][]Press the “New” button.
[][]Enter a “Name” for the new message & then press “Enter”.
[][]Set the “message settings” before selecting to the “Add field”
[][]Select “logo” from the “Field select” screen using the cursor buttons & press “Enter”.
[][]From the selection screen select the logo by using the up/down cursor buttons. When the required logo is displayed on the screen press “Enter”.
[][]The logo will now be displayed in message screen. Field settings can be changed at this point. Ensure the correct font size is selected on the message settings. Screen.
[][]Press “Enter” to save the message & then press “Enter” again to return to the store screen. Press “Start Print” to print the highlighted message & return to the Home page.

Annexure:

Annexure-I : Equipment log book

Digital weighing balance , Purpose:

Digital weighing balance, To lay down the procedure for operation, accuracy check and cleaning of the weighing balances at the Packaging Area.

Digital weighing balance, Scope:

This SOP is applicable for 510 g weighing balance for weighing of materials at the Packaging Area of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

N/A

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]To follow the laid down procedure

Executive, Packaging

[][]To monitor and check the cleanliness of area

Manager, Production

[][]To implement this correctly

Head of Quality Assurance

[][]To approve the Document

Procedure:

Precaution:

[][]Do not pour liquids on the weighing platform.
[][]Do not use solvents to clean the platform.
[][]Ensure balance is clean before use, including its surrounding area.
[][]Check and ensure the due date of calibration before use.
[][]Check and ensure the level indicator of weighing balance is in the middle, if applicable.
[][]Use hand gloves to hold standard weights for function check and calibration.

Daily Performance Check :

[][]Plug in the power cord.
[][]Level the balance using leveling feet so that air bubble is centered within circle of level indicator.
[][]To turn the balance ON, short pressing the → O/T ← key.
[][]Wait a while so that the stability indicator [*] is displayed.
[][]Zero the balance by pressing the → O/T ← key.
[][]Press the 100 mg mass at the centre of the platform and record the value displayed in the daily balance check logbook.
[][]Press the 100 g mass at the centre of the platform and record the value displayed.
[][]Press the 200 g mass at the centre of the platform and record the value displayed.
[][]Print the results by pressing print ( ) button if necessary.
[][]Record the value of those weights in Log Book for Daily Accuracy Check (As per Form No.: SOP/ PRO/004/I).
[][]If any displayed value is out of acceptable limit, label the balance “DO Not Use” and inform the QA Executive for immediate calibration of the balance.
[][]Balance check must be performed every working day before starting operation.
[][]If the factory remains close for the day(s), put the comments in the remarks column against that day(s) at the day of factory resume.

Operation of 510 gm Balance of OHAUS :

[][]Empty container for Weighing:
[][]Press the zero button.
[][]Place an empty container on the scale platform.
[][]Press the Tare button.
[][]Fill the container with material to be weighed.
[][]The terminal will display the net weight and the NET cursor will light up. Allow the reading to be stable. Write down the reading.
[][]To clear a tare weight (with the scale in the net weight mode and a tare weight previously entered),press the Clear key (C)

Filled container for Weighing:

[][]Press the zero button.
[][]Place the material to be weighed on the scale platform.
[][]The terminal will display the net weight and the NET cursor will light up. Allow the reading to be stable. Write down the reading.
[][]Follow the Daily Accuracy Check

Acceptance Criteria:

[][]The observed weights should be within ± 0.1% of the certified standard weights.
[][]If the acceptance criteria are not satisfied, follow the procedure for Handling of out of calibration for instrument & equipment.

Calibration:

[][]Perform the calibration in every six months. Recalibration is required in the following cases :
[][]After any minor service has been done or replacement of parts.
[][]When the software or firmware has been upgraded or changed.
[][]If daily check fails.

Cleaning:

[][]Place the status label ‘TO BE CLEANED’ on the equipment.
[][]Switch off the balance and unplug from the socket.
[][]Remove all objects from the weighing platform of balance.
[][]Lift up and remove the weighing pan in such a way that there is no damage in weighing system.
[][]Clean the pan including underside using a piece of dry cloth. Use wet cloth and finally clean with disinfection solution
[][]Wipe the display, switch board and cables with dry cloth.
[][]Remove ‘TO BE CLEANED’ and affix ‘CLEANED’label on the equipment after approval from Quality Compliance.
[][]Record the cleaning parameters on the ‘Equipment Log Book’.

Annexure:

N/A

Excess Secondary Packaging materials, Purpose:

Excess Secondary Packaging materials, To lay down the procedure for transfer of Un-used Secondary Packaging Materials to Ware-House.

Excess Secondary Packaging materials, Scope:

This SOP is applicable for the Packaging Area of XX Pharmaceuticals Limited.

Definition / Abbreviation:

[][]Secondary Packaging Material: That Packaging Material which contains the primary packed product and has the Printed Information.

Responsibilities:

[][]The Roles and Responsibilities are as follows :

Operator

[][]To follow the laid down procedure.

Executive, Packaging

[][]To monitor and check the laid down procedure.

Manager, Production

[][]To implement this correctly.

Manager, Quality assurance

[][]To approve the Document.

Annexure:

N/A.

Procedure:

Precaution:

[][]Only the fresh and un-used parts of Secondary Packaging Materials are to be returned to the Ware-House without any Defective.
[][]Returning of Unused Secondary Packaging Materials
[][]Responsible Person / Supervisor shall take necessary measures to return the un-used part of received Secondary Packaging Materials and Packaging Person shall ensure the return of all the Un-used Secondary Packaging Materials after completion of each Batch Packaging.
[][]Secondary Packaging Materials such as Spoon, Measuring Cup, Plastic Dropper, Sticker Label, Inner Cartons, Inserts, Shipper Cartons which are to be returned shall be counted.
[][]Executive, Packaging shall visually check and ensure that no overprinted Packaging Materials like Sticker Label, Inner Cartons, Shipper Cartons are to be returned to the Ware-House.
[][]Enter all the details like Product Name, Batch No., Batch size, Name of the Material, Material ID, Lab. Control No., Quantity to be Returned on the ‘Stock Return Note’
[][]Operator shall mention all details in Stock Return Note (SRN) and Executive, Packaging shall check all of them accordingly.
[][]The SRN shall have triplicate copy. All the copies shall be moved along with the physical stock to the Ware-House and Executive / In-charge, Ware-House shall return the rest of 02 (Two) copies to the Packaging after duly signed. One copy shall attach with Batch Packaging Record and another copy shall retain in the book as reference copy.

Secondary Packaging materials receiving , Purpose:

Secondary Packaging materials receiving , To lay down the procedure for Receiving of Batch Required Secondary Packaging Materials from Ware-House.

Secondary Packaging materials receiving , Scope:

This SOP is applicable for the Packaging Area of XX  Pharmaceuticals Limited.

Definition / Abbreviation:

[][]Secondary Packaging Material: Secondary packaging is outside the primary packaging, perhaps used to group primary packages together & giving the best possible protection for products on the way to retail.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]To follow the laid down procedure

Executive, Packaging

[][]To monitor and check the laid down procedure

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Precaution:

[][]Check the Requisition carefully before sending to Ware-House.
[][]Prepared the Secondary Packaging Materials Requisition and sending it to the respective person of the Ware-House after taking approval from the Head of Production.
[][]After receiving the formal requisition from Packaging, In-Charge, Ware-House will check the latest stock position of the required items one by one.
[][]When present stock complies, then go for checking QA Passed stock one by one.
[][]As the Reel Type Packaging Items (e.g. Sticker Label) have the reasonable pack intact, and to be used pack-wise.
[][]When other Packaging Materials (Inner carton, Insert, Label, Cup, Dropper, Shipper carton, Cellulose tape) are available that time In-Charge, Ware-House will issue them and supply them on the basis of the materials requisition by the Ware-House Personnel to the Packaging Area.
[][]After complete delivery from the Ware-House, respective Packaging In-Charge / Supervisor will confirm their receipt of correct item(s) with quantity by signature. Update the ‘Material Issue Record’ register (Annexure-I).
[][]When the schedule batch(s) will consumption, then un-used and fresh part will be kept in their outer pack and send to the respective Ware-House.
[][]Ware-House Personnel keep the Secondary Packaging Materials at the designated Place(s) with sequential order.

Annexure:

Annexure I – Material Issue Record.

Sticker labeling machine, Purpose:

Sticker labeling machine, The purpose of this SOP is to describe the Set up, Operation and Cleaning of Sticker labeling machine in order to comply with cGMP standard.

Sticker labeling machine, Scope:

This SOP is applicable for the Packaging Area of XX  Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]Operation and cleaning of the Sticker labeling machine
[][]Maintaining Equipment Log Book.

Executive, Packaging

[][]To monitor and check the laid down procedure.

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Annexure:

N/A.

Procedure:
Precaution :

[][]Always turn OFF the machine before threading the label web through the machine.
[][]Keep hands away from moving machine parts while machine is in operation.

Machine Assembling

[][]Before operation assemble the machine accessories that are necessary for operation.
[][]Set the Batch no. Mfg date and Exp date on the hot stamp Printer.
[][]Set Label and carbon roll.

Machine Operation

[][]Connect the electrical cable and compressed air line.
[][]ON main power switch.
[][]Press ENTER on the PLC.
[][]Select mode form PLC as specified.
[][]Switch ON the turn table.
[][]Press Label ON from PLC.
[][]Press Print ON from PLC.
[][]Press counter ON from PLC.
[][]Adjust label on the label roll of the machine.
[][]Press RUN button on the PLC.
[][]Record the machine operation start time & end time and other parameters on the ‘Equipment Log Book’.

[][]Machine Dismantling

After operation disassemble the machine accessories.
Remove the hot stamp printer for changing Batch no. Mfg date and Exp date.

Machine Cleaning

[][]Remove dusts from the machine with a vacuum cleaner.
[][]Clean all the machine parts with dry lint free cloth then with wet mop.
[][]Swab the machine body and change parts with lint free cloth.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the Equipment Log Book.

Digital Weighing Balance operation, Purpose:

Digital Weighing Balance operation, To lay down the procedure for operation, accuracy check and cleaning of the weighing balances at the Packaging Area.

Digital Weighing Balance operation, Scope:

This SOP is applicable for 820 gm weighing balance for weighing of materials at the Packaging Area of XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:\

Operator

[][]To follow the laid down procedure

Executive, Packaging

[][]To monitor and check the cleanliness of area

Manager, Production

[][]To implement this correctly

Head of Quality Assurance

[][]To approve the Document

Annexure:

N/A

Procedure:
Precaution:

[][]Do not pour liquids on the weighing platform.
[][]Do not use solvents to clean the platform.
[][]Ensure balance is clean before use, including its surrounding area.
[][]Check and ensure the due date of calibration before use.
[][]Check and ensure the level indicator of weighing balance is in the middle, if applicable.
[][]Use hand gloves to hold standard weights for function check and calibration.

Daily Performance Check :

[][]Plug in the power cord.
[][]Level the balance using leveling feet so that air bubble is centered within circle of level indicator.
[][]To turn the balance ON, short pressing the → O/T ← key.
[][]Wait a while so that the stability indicator [*] is displayed.
[][]Zero the balance by pressing the → O/T ← key.
[][]Press the 100 mg mass at the centre of the platform and record the value displayed in the daily balance check logbook.
[][]Press the 100 g mass at the centre of the platform and record the value displayed.
[][]Press the 200 g mass at the centre of the platform and record the value displayed.
[][]Print the results by pressing print ( ) button if necessary.
[][]Record the value of those weights in Log Book for Daily Accuracy Check (As per Form No.: SOP/ PRO/004/I).
[][]If any displayed value is out of acceptable limit, label the balance “DO Not Use” and inform the QA Executive for immediate calibration of the balance.
[][]Balance check must be performed every working day before starting operation.
[][]If the factory remains close for the day(s), put the comments in the remarks column against that day(s) at the day of factory resume.

Operation of 820 g Balance of Mettler Toledo :

Empty container for Weighing:

[][]Press the zero button.
[][]Place an empty container on the scale platform.
[][]Press the Tare button.
[][]Fill the container with material to be weighed.
[][]The terminal will display the net weight and the NET cursor will light up. Allow the reading to be stable. Write down the reading.
[][]To clear a tare weight (with the scale in the net weight mode and a tare weight previously entered),press the Clear key (C)

Filled container for Weighing:

[][]Press the zero button.
[][]Place the material to be weighed on the scale platform.
[][]The terminal will display the net weight and the NET cursor will light up. Allow the reading to be stable. Write down the reading.
[][]Follow the Daily Accuracy Check.

Acceptance Criteria:

[][]The observed weights should be within ± 0.1% of the certified standard weights.
[][]If the acceptance criteria are not satisfied, follow the procedure for Handling of out of calibration for instrument & equipment.

Calibration:

[][]Perform the calibration in every six months. Recalibration is required in the following cases :
[][]After any minor service has been done or replacement of parts.
[][]When the software or firmware has been upgraded or changed.
[][]If daily check fails.

Cleaning:

[][]Place the status label ‘TO BE CLEANED’ on the equipment.
[][]Switch off the balance and unplug from the socket.
[][]Remove all objects from the weighing platform of balance.
[][]Lift up and remove the weighing pan in such a way that there is no damage in weighing system.
[][]Clean the pan including underside using a piece of dry cloth. Use wet cloth and finally clean with disinfection solution
[][]Wipe the display, switch board and cables with dry cloth.
[][]Remove ‘TO BE CLEANED’ and affix ‘CLEANED’  label on the equipment after approval from Quality Compliance.
[][]Record the cleaning parameters on the ‘Equipment Log Book’ .

Annexure:

Annexure I Equipment Use Log Book

Line Clearance , Purpose:

Line Clearance , To lay down the Procedure for Line Clearance at the Packaging Area.

Line Clearance , Scope:

This SOP is applicable for the Packaging Area of XX Pharmaceuticals Limited.

Definition / Abbreviation:

Line Clearance : Line Clearance is a method of assuring components, labels, and documents have been removed and accounted from the previous work order for before starting a new work order and to make certain the line is properly prepared for the next work order.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]To follow the laid down procedure

Executive, Packaging

[][]To monitor and check the laid down procedure

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Precautions:

[][]Ensure the proper safety instructions are followed.
[][]Ensure that no previous product is available in the area.
[][]Line Clearance during Product to Product Changeover
[][]Clean all utility lines like compressed air line, air inlet ducts and return air risers with dry mop to remove loose dust from the floor.
[][]Clean the door, floor, walls and ceiling with dry cloth & finally wet mop.
[][]Area cleaning activity is recorded in ‘Room Cleaning Log book’
[][]Clean all equipment in the area according to their respective SOPs and no traces of previous product are visible within the equipment.
[][]Check and ensure that equipment cleaning activity is recorded in respective ‘Equipment Log Book’
[][]Ensure that Span between equipment usage and cleaning is not more than seventy two hours.
[][]Balances, if available in the packaging area, are cleaned and accuracy check is done before use.
[][]Fresh set of gowns are issued to concerned operators.
[][]Proper environmental condition is maintained in the area and the records of the same are maintained in the specified formats.
[][]Ensure the correctness of Batch Packaging Record.

Line Clearance during Batch to Batch Changeover

[][]Ensure that previous batch material is removed from the packaging area.
[][]Ensure that all equipment and their spares are cleaned according to their respective SOPs.
[][]Ensure that equipment cleaning activity is recorded in respective ‘Equipment Log Book’.
[][]Ensure that floor is cleaned using vacuum cleaner and no visible traces of the previous batch materials on the floor.
[][]Proper environmental condition is maintained in the area and the records of the same are maintained in the specified formats.
[][]Ensure the correctness of Batch Packaging Record.

Annexure:

Annexure I Equipment Use Log Book