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

Packaging Area Cleaning, Purpose:

Packaging Area Cleaning, To lay down the procedure for effective cleaning at the Packaging Area.

Packaging Area Cleaning, 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 cleanliness of area

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Precaution:

[][]Do not clean/disinfect the area when the packing is running.
[][]Keep the cleaning agents at the designated place only with proper labels.
[][]Ensure that after usage the wet mops are washed and hanged in hanger in cleaner store & allowed to dry. Ensure other cleaning tools are also hanged in hanger after use.
[][]After use of cleaning agent wash hands, feet and fingers thoroughly with soap & plenty of water.
[][]Ensure that during cleaning all the product containers are closed.
[][]Check and ensure that disinfectant solution prepared is not stored for use for the next day and the residue is discarded by pouring into drain.
[][]At least two different disinfectants are to be used alternatively on weekly basis..
[][]Do not mop the floor after keeping Cleaned equipment in clean equipment storage room.

Cleaning Tools / Agents

[][]Portable vacuum cleaner
[][]Cloth & wiper
[][]Potable water
[][]Glass Cleaning agent: ‘Clear View’ (Brand Name).
[][]Disinfectant (Savlon/ Dettol/ Chlotec).
[][]Floor cleaning agent Perfect 7/Enviro Care
[][]Preparation of 2.5 % v/v Chlorhexidine Gluconate Solution
[][]To make 10 L disinfectant solution take 2.5 L Chlorhexidine Gluconate in freshly collected purified water to make up volume up to 10 L).
[][]Stir well to mix the solution properly.
[][]Prepare the disinfectant solution separately in separate bucket for use in different floor.
[][]Maintain the ‘Disinfectant Solution Preparation Record’.

Product to Product Cleaning Procedure (Type-A Cleaning) for Secondary Packaging Area

[][]Type – A cleaning is defined as cleaning procedure followed during product to product changeover.
[][]If the unit/equipment is used for same product it has to be cleaned after 72 hours.
[][]Place the status label ‘TO BE CLEANED’  in the Area.
[][]Clean the ceiling, walls, light fixtures, supply diffusers (SD) and return grills (RG) first with portable
[][]Vacuum cleaner to remove loose dust using a platform trolley, then with wet mop.
[][]Clean the machine/Equipment in packaging are As per SOP.
[][]Clean the doors, windows, compressed air lines and other service lines with dry cloth and then wet mop.
[][]Clean the glasses with ‘Clear View’ solution and wipe.
[][]Clean the control panels, electrical wires with dry cloth.
[][]Clean toolbox, table, log books, SOP folders, hygrometer, stool / chair with dry Cloth.
[][]Clean the floor first with dry mop, then with Perfect 7/Enviro Care and finally with potable water.
[][]Ensure after inspection for absence of any residue of previous product. If any residue of previous product or extraneous matter is found, re-clean the area using above procedure until the area is free of any residue/ extraneous matter.

[][]Remove ‘TO BE CLEANED’ and affix ‘CLEANED’ label in the cleaned area.
[][]Record the cleaning activity in ‘Room Cleaning Log Book’.

Frequency of Cleaning

[][]During product to product change over.
[][]If 72 hours time exceeds after cleaning and the equipment or area is not used, use the equipment or area after performing B-type cleaning.

Batch to Batch Cleaning (Type-B Cleaning) for Secondary Packaging area

[][]Type – B cleaning is defined as cleaning procedure followed during batch to batch changeover of a particular product.
[][]Place the equipment status label ‘PARTIALLY CLEANED’  in the area.
[][]First Clean the floor, ceiling, walls, light fixtures, supply diffusers (SD), return grills (RG) doors, windows and equipment with portable vacuum cleaner to remove the loose dust. Finally clean the floor with wet mop.
[][]Remove ‘PARTIALLY CLEANED’ label and affix ‘CLEANED’ label in the area.
[][]Record the cleaning activity in ‘Room Cleaning Log Book’.

Frequency of Cleaning

[][]During batch to batch change over.

Cleaning at the End of Day’s Operation

[][]Clean external parts of the machine, and operating panel with dry cloth.
[][]Clean the floor first with dry mop and finally with disinfectant solution.
[][]Frequency of Cleaning
[][]At the end of the day’s work.

Transfer of Finished Goods, Purpose:

Transfer of Finished Goods, To lay down the procedure for to the Finished Goods Storage Area.

Transfer of Finished Goods, 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 laid down procedure

Manager, Production

[][]To implement this correctly

Head of Quality Assurance

[][]To approve the Document

Annexure:

Annexure I – Finished Goods Transfer Note.
Annexure II – Weight Checking Record of Inner Carton
Annexure III – Weight Checking Record of Shipper Carton

Procedure:

Precautions:

[][]Do not transfer finished goods to the Finished Goods Storage area without Quality Compliance (QCOM) approval.
[][]Warehouse personnel should not receive finished goods from Production without any ‘Finished Goods Transfer Note’.
[][]Ensure that proper labels are on shipper carton & pallet.
[][]Check the weight of individual inner carton and keep record at 30 minutes interval in Annexure-II (Weight Checking Record of Inner Carton).
[][]Attach the Transparent Hologram Sticker on inner carton.
[][]Place the inner cartons in shipper carton and seal the shipper carton using gum tape.
[][]Check and ensure that ‘PRODUCT LABEL’  of shipper carton (Product name, Batch No., Mfg. Date, Exp. Date, Pack Quantity, Sr. No., Packed by, Storage Condition) is legible and clear.
[][]Check the weight of individual shipper carton and keep record of every shipper carton’s weight in Annexure-III (Weight Checking Record of Shipper Carton).
[][]Seal on every shipper carton as the following using rubber stamp (L-3.25 inch X W-2.0 inch) and record the relevant information which corresponds with Annexure-III.

SHIPPER CARTON NO.:………………….

WEIGHT:……………………………………….

NAME:…………………………………………..

SIGNATURE AND DATE:……………….

[][]Keep the shipper cartons on a clean pallet. Use more than one pallet if required to keep shipper cartons on it.
[][]In case of Loose shipper carton affix ‘LOOSE LABEL’  on two sides of shipper carton (Front & Back).
[][]Prepare a ‘Finished Goods Transfer Note’ after completion of packing of a batch as per format (Annexure – I).
[][]QCOM shall affix ‘QUARANTINED’ label on pallet.
[][]When the batch is approved by Quality Compliance (QCOM), hand over the batch along with Finished Goods Transfer Note to warehouse personnel.
[][]Maintain batch details in ‘Finished Goods Register’ Production personnel will sign as ‘Transferred by’ and warehouse personnel as ‘Received by’ in the Finished Goods Register.

Annexure:

Annexure I – Finished Goods Transfer Note.
Annexure II – Weight Checking Record of Inner Carton
Annexure III – Weight Checking Record of Shipper Carton