SOPs

Container Washing and Handling System of Dialysis Fluid Unit

Purpose :

The purpose of this SOP is to describe the procedure of container Washing and Handling system of Dialysis Fluid Unit at XX Pharmaceuticals Ltd.

Scope :

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

Definition / Abbreviation :

[][]HDPE: High Density Polyethylene

Responsibilities :

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

Operator

[][]To ensure that this procedure is followed.

Executive, Production

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

Manager, Production

[][]To implement this correctly.

Head of Quality Assurance

[][]To approve the SOP.

Precautions :

[][]Ensure the Proper Safety Instruction Are Followed.
[][]Ensure that the Supply the Water (Potable, Hot & Purified).

Empty Container Washing Procedure :

[][]Send the ERP Requisition to the ware house, then they Provide QC passed Containers from General Warehouse.
[][]Places the containers (50pcs) at the Plastic Pallet and transfer to the container washing room.
[][]Ensure that all utility lines like compressed air, electric line, potable water (hot & normal) and purified water are in attendance.
[][]Put off the stopper plug.
[][]Placed the container perpendicularly (3Pcs at a time) at the washing machine then flow the potable water for 30 sec (inner & outer elevation).
[][]Supply the hot water (50 to 60o) into the containers for 30 sec (inner & outer elevation).
[][]Concluding Supply of Purified water into the containers for 30 sec (inner & outer elevation).
[][]After that washed container staging at the cage trolley, then transfer to the filling room.
[][]Ensure that area cleaning activity is recorded in Cleaning Log book
[][]Check and ensure that Containers Cleaning activity is recorded in respective ‘Equipment log book’
[][]Ensure that all Containers are labeled as CLEANED.

Annexure

Annexure-I: HDPE Container (10 L) Washing Record.

Container Washing and Handling System of Dialysis Fluid Unit Read More »

Product Changeover of Dialysis Fluid Unit

Production, SOPs

Product Changeover, Purpose :

Product Changeover, To lay down the Procedure of Product Change Over to the Production and Packaging Area during Product to Product changeover and Batch to Batch Changeover for Dialysis Fluid Unit(DFU)

(DFU).

Product Changeover, Scope :

This SOP is applicable for the Concern Personnel of Production and Packaging of DFU Unit at XX Pharmaceuticals Limited.

Definition / Abbreviation :

N/A

Responsibilities :

[][]The roles and responsibilities are as follows :

Operator

[][]To follow the laid down procedure.

Laundry Man

[][]To provide cleaned garments.

Executive, Production

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

Manager, Production

[][]To implement this correctly.

Head of Quality Assurance

[][]To approve the SOP.

Precautions :

[][]Ensure the proper safety instructions are followed.
[][]Ensure that no previous product is available in the area.

Product to Product Changeover :

[][]Ensure that, all utility lines like compressed air line, steam line, electrical fixtures, air inlet ducts, return air risers, potable water and purified water lines are cleaned and no visible traces of product are present.
[][]Ensure that Outer surface of machine, table, door, floor, walls and ceiling are cleaned.
[][]Ensure that Pre-mixing, Mixing, Storage, Filling Vessel to be clean with plenty of water (First time Potable Water Finally Purified water).
[][]Ensure that area cleaning activity is recorded in ‘Room Cleaning Log Book’
[][]Ensure that all equipments in the area are cleaned 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.
[][]Ensure that Balances in the production area are cleaned and accuracy check is done before use.
[][]Ensure that production utensils like scoops, spatula, sieve stand, punch trolley, pallets, BMR table and tool boxes are cleaned as per procedure.
[][]Ensure that all equipments are labeled as ‘CLEANED’.
[][]Ensure that fresh set of gowns are issued to concerned operators.
[][]Ensure that 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 Manufacturing Record / Batch Packaging Record.

Batch to Batch Changeover :

[][]Ensure that previous batch material is removed from the production area.
[][]Ensure that all the equipment and their spares are cleaned according to their respective SOPs.
[][]Ensure that equipment cleaning activity is recorded in respective ‘Equipment Log Book’.

Annexure:

Annexure I Equipment Use Log Book

Product Changeover of Dialysis Fluid Unit Read More »

Material and Man Flow of Dialysis Fluid Production Area

Production, SOPs

Material and Man Flow, Purpose :

Material and Man Flow, To lay down the procedure of Material and Man Flow to the Production and Packaging Area for Dialysis Fluid .

Material and Man Flow, Scope :

This SOP is applicable for the Concern Personnel of Production and Packaging of Dialysis Fluid Unit(DFU) of the XX Pharmaceuticals Limited.

Definition / Abbreviation:

[][]BOM = Bill of Material
[][]QAD = Quality Assurance Department
[][]DFU= Dialysis Fluid Unit

Responsibilities:

[][]The roles and responsibilities are as follows:

Operator

[][]To follow the laid down procedure.

Laundry Man

[][]To provide cleaned garments.

Executive, Production

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

Manager, Production

[][]To implement this correctly.

Head of Quality Assurance

[][]To approve the SOP.

Annexure:

N/A

Precautions :

[][]Do not step on the floor with bare foot.
[][]Rub hands with Disinfectant Solution before entering into the Production Area.
[][]Jewelry, Wrist Watch, Finger Ring & Ear Ring is not allowed to Production Area.
[][]No food is allowed to Production Area.
[][]Shoe>Cover >Cap >Apron >Mask.
[][]After wearing company provided dress, stand in front of the mirror and confirm that, clothing is covering full arms and cap is covering all hairs according to the sample photos displayed.
[][]Proceed towards the DFU Unit.

MAN FLOW ( Starting from D Change ) :

[][]Before entering into the primary change room, Personnel should complete secondary change as per procedure.
[][]Enter into the Primary Change Room.
[][]Rub hands with Disinfectant Solution (70% Iso-Propyl Alcohol).
[][]Open the door of Corridor, turn left side and proceed to the Production as well as Container Washing Area of DFU.

MATERIALS FLOW ( Starting from Ware-House, Solid Block ) :

[][]Collect Materials from Cargo Lobby (less than 25 Kg) for dispensing at the Dispensing Booth (GPR009) of General Block.
[][]Ensure that, around 25 Kgs. in a single Bag / Pack transfers directly to the DF Unit Air-Lock.
[][]Ensure that, all the materials dispensed as per BOM are to be needed to transfer to the Manufacturing Area of the DFU.
[][]Liquid Material (Glacial Acidic Acid) is to be collected from the Flammable Storage Area.
[][]Filled Containers (10L) are to be transferred to the Secondary Packaging Area of General Block by using transfer trolley.
[][]The received Filled Containers (10L) are taken to the Packaging Conveyor for proper Wiping, Labeling and Packaging.
[][]Packed Products as a whole batch are to be taken to the Quarantine Area on Pallets for QA Release.
[][]After getting QA Release Slip, the Finished Goods (as a whole batch) are to be transferred to the Central Ware-House through the Warehouse of Solid Block.

Material and Man Flow of Dialysis Fluid Production Area Read More »

Filter Cleaning, Regeneration & Storage System

Production, SOPs

Filter Cleaning, Purpose :

Filter Cleaning, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Cartridge filter in order to comply with cGMP standard.

Filter Cleaning, Scope :

The scope of the procedure is applicable to the Cartridge filter of Dialysis Fluid of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]CIP : Clean In Place

Responsibilities:

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

Operator

[][]Operation and cleaning of the cartridge filter.
[][]Maintaining Equipment Log Book.

Executive, Production

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

Manager, Production

[][]To implement this correctly.

Head of Quality Assurance

[][]To approve the SOP.

Annexure:

N/A

Precautions :

[][]Hot purified water should be not more than 60oc.
[][]The wash-down valves are in closed position.
[][]Check for any leakage from discharge valve.

Filter Cleaning:

[][]Remove the Filter housing from the Vessel.
[][]Cleaning of filter Cartridge (1.2, 0.45 & 0.2 micron or 1.0, 0.6 & 0.2 micron).
[][]Clean the Cartridge filter (1.2, 0.45 & 0.2 micron or 1.0, 0.6 & 0.2 micron) with potable water.
[][]Soak the Cartridge filter in hot purified water and retain for 30 minutes.
[][]Wash the Cartridge filter 3 times with purified water.
[][]Allow the Cartridge filter to dry in wash bay.
[][]After drying take the Cartridge filter in a Clean poly bag and Stored in Closed ss Cabinet.
[][]After final cleaning affix the ‘CLEANED’ label.

Filter Cleaning, Regeneration & Storage System Read More »

Dialysis Fluid Filling Machine set up, operation and cleaning

Production, SOPs

Dialysis Fluid Filling Machine, Purpose :

Dialysis Fluid Filling Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of filling machine in order to comply with cGMP standard.

Dialysis Fluid Filling Machine, Scope :

The scope of the procedure is applicable to the filling machine at the production area of dialysis Fluid unit of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]LAF = Laminar Air Flow.
[][]PVC = Polyvinyl Chloride.

Responsibilities :

[][]The roles and responsibilities are as follows:

Operator

[][]Operation and cleaning of the filling machine.
[][]Maintaining equipment log book.

Executive, Production

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

Manager, Production

[][]To implement this correctly.

Head of Plant Operation

[][]To agree the laid down procedure.

Head of Quality Assurance

[][]To approve the SOP

Procedure :

Precautions :

[][]Use face mask, rubber gloves and protective clothing during filling operation.
[][]Turn ON LAF before filling operation.
[][]Connect electric line properly.
[][]Filling vessel valves are in open position.
[][]Check any leakage from discharge valve, silicon pipe and filling piston.

Machine Assembling :

[][]Clean the machine well with lint free cloth.
[][]Assemble the machine change parts and all the connections that are necessary for certain types of Operation.
[][]Attach tightly the silicon pipe (2’’) to the storage vessel (2000L).
[][]Attach tightly the solution transfer pipe (1½’’) to the dosing unit.
[][]Covert the filling machine by the PVC curtain.

Machine Operation:

[][]Lock the chamber lid cover of 200L vessel properly.
[][]Turn the transfer pump ON/OFF key to ON.
[][]Transfer 2000 L solution from storage vessel (2000 L) by opening the gate valve of storage vessel.
[][]This system is done by product filling end times.
[][]Turn the filling machine ON/OFF key to ON.
[][]Placed two containers under the dosing nozzle pipe
[][]Wait for two dosing rotation per container (5Liters/Stroke) then push OFF button.
[][]Look the actual filling volume of the containers.
[][]Push the OFF button of filling machine if container supplies insufficient or any other problems.
[][]Check the solution during filling by looking at the vision area of lid cover.
[][]Transfer or sample the solutions by opening the sampling port valve manually.
[][]Push the OFF button to stop the machine and plug out the main electric line to its main.
[][]Record the machine start time, end time and other parameters in the ‘Equipment Log Book’

Machine Dismantling :

[][]Turn the machine ON/ OFF key to OFF the machine.
[][]Remove the solution transfer pipe and filling pipe manually.
[][]Remove the lid cover and turn OFF the stirring.
[][]Remove the electric industrial plug.

Machine Cleaning :

[][]Clean the machine with lint free cloth to remove dust.
[][]Clean the inner elevation of the filling machine by using potable water.
[][]Clean the inner elevation of the filling machine by using hot water.
[][]Clean the inner elevation of the filling machine by using purified water through pipe.
[][]Clean the outer elevation of the filling machine with potable water by rubbing with a lint free cloth.
[][]Soak with a clean dried lint free cloth to remove the water from the filling machine.
[][]Clean all of the machine parts with potable water, hot water then purified water.
[][]Soak with a clean dried lint free cloth to remove the water from the machine parts.
[][]Affix the clean label on the filling machine as ‘CLEANED’.

Annexure:

Annexure I Equipment Use Log Book

Dialysis Fluid Filling Machine set up, operation and cleaning Read More »

Induction Sealing Machine Set Up, Operation & Cleaning

Packaging, Production, SOPs

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.

Induction Sealing Machine Set Up, Operation & Cleaning Read More »

Pre-Mixing Vessel Set Up, Operation and Cleaning

Production, SOPs

Pre-Mixing Vessel, Purpose :

Pre-Mixing Vessel, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Pre-mixing Vessel in order to comply with cGMP standard.

Pre-Mixing Vessel, Scope :

The scope of the procedure is applicable to the Vessels at the Production area of Kidney Dialysis Fluid (KDF) of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]CIP : Clean In Place

Responsibilities:

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

Operator

[][]Operation and cleaning of the Pre-mixing Vessel.
[][]Maintaining Equipment Log Book.

Executive, Production

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

Manager, Production

[][]To implement this correctly.

Head of Quality Assurance

[][]To approve the SOP.

Procedure

Precautions :

[][]Chamber cover is properly locked.
[][]The wash-down valves are in closed position.
[][]Check for any leakage from discharge valve.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.

Machine Assembling

[][]Clean the machine well.
[][]Assemble the machine change parts and all the connections that are necessary for certain types of operation.
[][]Attach the vacuum material transfer unit to the lid cover to transfer Liquid material automatically.
[][]Attach the solution transfer unit to the lid cover to transfer solution automatically by pressure.
[][]Attach the vision unit with clamp to the cover of chamber.

Machine Operation:

[][]Lock the chamber cover with chamber cover locking. Check for proper locking.
[][]Turn the machine ON/OFF key to ON. the machine is ON.
[][]Set the impeller Rotation Per Minute (RPM) and process time to desired value at the regulator at SETUP button (user can change the Impeller speed)
[][]Look the actual speed of the impeller.
[][]To off the impeller off button.
[][]To add solution or water open the chamber covers and then transfers the solution or water pneumatically.
[][]To stop the machine immediately, push the EMERGENCY button backward, machine will be stopped immediately.
[][]To check the solution during process OFF the impeller. Lift the lid cover manually and check.
[][]To Transfer or sample the solutions open the discharge valve manually.
[][]Transfer the solution through the Filter Housing control button (manual option is available).
[][]When discharge is complete push the CLOSED button to close the discharge valve.
[][]Transfer the Solution in product to Mixing Vessel (2000L).
[][]Push the OFF button to stop the Machine.

Machine Dismantling

[][]Turn the machine ON/ OFF key to off the machine.
[][]Remove the solution transfer unit.
[][]Remove the Lid Cover and Vision unit.
[][]Remove the Sample Collection unit.
[][]Remove the Filter housing from the Vessel.

Machine Cleaning

Cleaning of Vessel

[][]Fill the Vessel with Potable Water, the inner surface of the vessel well enough to washout the processing materials .Clean the outer surface of the vessel with rubbing & plenty of potable and purified water.
[][]Stir for 5-10 min after sufficient amount of potable water 500L being aggregated at the bottom.
[][]Rub with brush on the top and side walls of the vessel.
[][]Transfer the total wash water to the Manufacturing Vessel 2000L.
[][]Clean the wall and top with the hot potable water.
[][]Rub with brush on the top and side walls of the vessel again.
[][]Fill the Vessel with Purified Water and stir 15 min and then transfer to mixing vessel.
[][]Transfer the total wash water from 500L to the Vessel 2000L, 2000L drainage via filling machine.
[][]Rinse the wall and top of the vessel with hot potable water again.
[][]Clean the top and wall of the vessel with dry lint free cloth.
[][]Rinse the outer and inner wall of the vessel with IPA.
[][]Remove all water from the vessel and pipe line with Compressed air flow.
[][]After final cleaning affix the ‘CLEANED’ label.

Annexure:

N/A

Pre-Mixing Vessel Set Up, Operation and Cleaning Read More »

Domino A-Series A-220 GP Ink Jet Printer Operation

Packaging, Production, SOPs

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

Domino A-Series A-220 GP Ink Jet Printer Operation Read More »

Digital weighing balance operation, accuracy check & cleaning at packaging Area

Packaging, Production, SOPs

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

Digital weighing balance operation, accuracy check & cleaning at packaging Area Read More »

Excess Secondary Packaging materials transfer to Warehouse

Packaging, Production, SOPs

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.

Excess Secondary Packaging materials transfer to Warehouse Read More »