SOPs

Rework Residue , Purpose:

Rework Residue , To lay down a procedure for Handling of Rework Residues from Batch Processed Material /Intermediate product.

Rework Residue , Scope:

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

Definition / Abbreviation:

[][]N/A

Responsibilities:

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

Operator

[][]To follow the laid down procedure.

Executive, Production

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

Manager, Production

[][]To implement this correctly.

Manager, Quality Assurance

[][]To approve the Document.

Procedure:

Precaution:

[][]Do not add any rework unless it is authorized beforehand by Head of Quality Assurance.
[][]Do not add the rework of a batch to other batch (es) until packing of the batch is completed.
[][]Ensure that rework of different products is not stored in the same container.
[][]Do not store any rework which is less than 0.25 % of the actual batch size.

Rework Residue :

[][]Following stated defects can be considered for storage and addition as rework in a batch leftover granules, chipping / capping defects, lamination, tablets with variations in physical parameters like weight, hardness, thickness, friability or edge broken tablets at the time of compression, coating and inspection. Residue after compression, encapsulation & PFS is also be considered as rework.
[][]Prepare a ‘Rework Residue Addition Note’ as per format (Annexure-I). The rework addition note shall be approved beforehand by Head of Production or his designate and authorized by Head of Quality Assurance.

[][]Process the rework as per Batch Manufacturing Record (BMR) of the specific product from the declared necessary step(s).
[][]Maximum allowable amount for addition of rework in a fresh batch is 5 % of actual batch size.
[][]Rework bulk shall be free from any foreign matter, objectionable color and / or odor.
[][]First batch of any product in which rework is added shall be kept for stability study.

Non-Rework :

[][]Any amount of tablets / capsule(s) which is collected as ‘Rework’ but is less than 0.25 % of the actual batch size shall be considered as ‘non-rework’.
[][]‘Non-rework’ shall be destroyed as per Quality Assurance SOP.

Storage of Rework :

[][]Store the rework in tightly closed double lined polybag with “REWORK’ Label in a container on a pallet in WIP Tablet/Capsule store.
[][]Rework of more than one batch of the same product can be stored in one container with proper status label.
[][]Record the rework generated from the batch(es) and their addition history in ‘Rework Residue
[][]Register’ as per (Annexure II). The register shall be kept in production Executive.
[][]Issue rework residues for use only in the presence of Production Executive.
[][]Rework generated from a batch shall be added to the batch(es) which are manufactured within the next three months. For example, rework generated from a batch manufactured in January shall be added to only the fresh batch manufactured within April, not to be added to the batch manufactured in May and so on. But in that case expiry of the fresh batch where rework is added shall be same as expiry of rework batch. In such cases rework shall not be stored for more than 90 days. If any rework amount is left after the said period, destroy the left over with prior approval of Quality Assurance (QA).

Annexure:

Annexure I – Rework Reside Addition Note.
Annexure II – Rework Residue Register.

Additional Materials Return procedure, Purpose:

Additional Materials Return procedure, To lay down the procedure for return of Additional Part of Raw (Excipient) and Primary Packaging materials to Ware-House.

Additional Materials Return procedure, Scope:

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

Definition / Abbreviation:

[][]N/A.

Responsibilities:

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

Operator

[][]To follow the laid down procedure.

Executive, Production

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

Manager, Production

[][]To implement this correctly.

Manager, Quality Assurance

[][]To approve the Document.

Procedure:

Precaution:

[][]Ensure weighing and counting of the materials is correct.
[][]Returning of Unused Raw Materials (Excipient)
[][]After dispensing unused Raw Material (Excipient) can return to store.
[][]Enter all the details like Product Name, Batch No., Batch size, Name of the material, Quantity to be returned, Material ID No., Lab. Control No. on the ‘Stock Return Note’ (Annexure – I).
[][]Operator shall mention all details in Stock Return Note (SRN) and Executive, Production 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 02 (Two) copies to the Packaging after duly signed. One copy shall attach with Batch Manufacturing Record and third copy shall retain in the book as reference copy.

[][]Returning of Unused Primary Packaging Materials
[][]After dispensing unused Primary Packaging Material can return to store.
[][]Individual rolls of Aluminum foil, PVDC and Alu bottom film which is return shall weigh and glass bottle, stopper and Alu cap shall count.
[][]Enter all the details like Product Name, Batch No., Batch size, Name of the material, Quantity to be returned, Material ID No., Lab. Control No. on the ‘Stock Return Note’ (Annexure – I).
[][]Operator shall mention all details in Stock Return Note (SRN) and Executive, Production 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 02 (Two) copies to the Packaging after duly signed. One copy shall attach with Batch Manufacturing Record and another copy shall retain in the book as reference copy.

Returning of Raw Materials (Excipient) / Primary Packaging Materials Rejecting Online

[][]When the raw materials (excipient) / primary packaging materials are observe to be defective on-line such as having lumps or foreign materials in case of raw materials (excipient) and sealing problem or pinholes in case of foils keep aside the material.
[][]On line rejected material shall return to warehouse as per handling of on line rejection guideline of QA.

Annexure:

Annexure I – Stock Return Note.

Machine Handling, Purpose :

Machine Handling, To lay down the procedure for handling of machine during breakdown.

Machine Handling, Scope :

This SOP is applicable for the Production 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, Production

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

Manager, Production

[][]To implement this correctly.

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Precaution :

[][]Ensure that proper safety instructions are followed.

Activities:

[][]Shut OFF the main switch of the electric connection.
[][]Inform working Exe. / Sr. Exe., Production about the break-down status of the machine and In-charge is needed to confirm the extent of break-down priority basis.
[][]After checking the nature of break-down, he will intimate Engineering department through ‘Maintenance Request Form’ ( Annexure – I ) Send it to the General Manager, Engineering or his nominee for immediate course of action.
[][]Put off others utility line immediately one by one, so that, the machine turns neutral.
[][]Collect all the processing materials / intermediates and also product into the air-tight container being available before break-down of the machine.
[][]Clean the machine surface and outside by the vacuum cleaner and also the lint free cloth.
[][]Display the label ‘Under Maintenance’ on the front side of the machine for declaring its status.
[][]Involve machine Operator(s) throughout the Maintenance Process for speed up the Engineering job.
[][]Record the total down time of the Machine in the ‘Equipment Log Book along with it’s cleaning for next processing.
[][]Inform Quality Compliance Personnel to verify the extent of machine cleaning for next processing.

Annexure:

Annexure I – Maintenance Request Form 

Material Requisition Procedure, Purpose:

Material Requisition Procedure, To lay down the procedure for raising Requisition of Material to the Ware-House.

Material Requisition Procedure, Scope:

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

Definitions / Abbreviation:

[][]N/A

Responsibilities:

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

Operator

[][]To follow the laid down procedure

Executive, Production

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

Manager, Production

[][]To Implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

[][]Material Requisition shall be raised in following cases.
[][]On line rejection: If approved raw material or packing material issued for the batch is rejected on line due to quality defects like black particles in raw material, hard lumps, smudged printing or no  printing on printed materials like foil, carton, insert, label and shipper and color variation beyond acceptable shade.
[][]Material consumed more than standard: In case dispensed raw material is compensated due to spillage, spray pipe leakage during coating, excess coating material and packaging materials required for recovery addition, excess foil consumption during blister pack machine setting, excess carton consumption during manual cartooning, printing problem of carton, catch cover, insert and shipper carton.
[][]Production Executive shall raise ‘Material Requisition’ (Annexure-I) by writing all details with reason in the ‘Remarks’ column and shall sign in ‘Requisitioned by’ row.
[][]Material Requisition (MR) shall have duplicate copy. First copy shall be mentioned as ‘Ware-House Copy’ at right top corner of Material Requisition form. Second copy shall be mentioned as ‘Batch Record Copy’ at right top corner of Material Requisition form.
[][]Head of Quality Assurance (QA) or his/her designate shall justify the reason for MR and will approve accordingly.
[][]Approved Material Requisition shall be sent to dispensing for Issuance.
[][]After Issuance of materials ‘Batch Record’ copy shall be attached with Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR) and ‘Ware-House Copy’ shall be sent to Ware-House for stock adjustment purpose.

Annexure:

Annexure I –Material Requisition.

Equipment Logbook, Purpose:

Equipment Logbook, To lay down the procedure for Maintaining Record of Equipment Usage, break-down, cleaning and change over functions during all Manufacturing Activities.

Equipment Logbook, Scope:

This SOP is applicable for the Production Area of General Block of the XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]Equipment : The implement, which is used at an Operation or Activity.

Responsibilities:

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

Operator

[][]To follow the laid down procedure

Executive, Production

[][]To monitor and check laid down procedure

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Use of Equipment Log Book :

[][]Equipment Log Book is to record equipment usage maintenance and cleaning record. The records are maintained to trace back the previous history.
[][]Maintain individual ‘Equipment Log Book’ (Annexure-I) for each equipment.
[][]Equipment log book format is divided in 05 parts
[][]Product Information
[][]Equipment usage details
[][]Cleaning details
[][]Change Over details
[][]Inspection and Approval
[][]Product Information
[][]Product name, Batch no., Batch size shall be recorded in log book.
[][]Each book is dedicated for each equipment
[][]Equipment usage details
[][]Product start time and end time shall be recorded in log book.
[][]This is applicable for each batch activity.
[][]Record the activity / batch operations shift wise in log book.

[][]All break times like Lunch time, Tea time, machine stoppage due to breakdown, machine stoppage at the end of the shift or day and machine stoppage due to power failure, only if restart time is more than 5 minutes.

Equipment cleaning details

[][]The equipment cleaning is applicable in following events.
[][]Batch changeover of the same product and different product.
[][]After cleaning if cleaned equipment is kept idle for more than defined hold time which shall be studied and incorporated in respective equipment SOP.
[][]If equipment is relocated /shifted within the facility as well as for new equipment.
[][]In case of cleaning after maintenance activity.
[][]In case of cleaning after area fumigation.
[][]After usage of equipment, clean it as per the procedure defined in respective equipment SOP.
[][]The type of cleaning shall be mentioned in specified column in log book.
[][]After cleaning is completed, inform QA (Quality Assurance) to inspect and approve for next activity.

Change Over Details :

[][]Change Over is applicable in following events.
[][]Change over is done for product to product change.
[][]Start and end time shall be mentioned in specified column in log book.
[][]After change over is completed, Executive, Production check setting of machine & will take step for next activity.

Inspection and Approval before usage

[][]Before usage Equipment, it is to be checked for its suitability for next activity by Executive, Production and then inspected and approved by Executive, Quality Compliance.
If production is on campaign basis, after every 10th batch, cleaning activity is carried out and details are recorded.
[][]During campaign of same product, equipment shall be cleaned as per respective equipment SOP but prior to start next batch approval shall be taken by Executive, Quality Compliance.

Additional Information at the Remarks Column

[][]Throughout the working day operation, if the operating machine turns ‘Stop’ by either mechanical or electrical reasons, note the total down time for a day at the Remarks column.

Annexure:

Annexure I – Equipment Log Book.

Line Clearance , Purpose:

Line Clearance , To lay down the procedure for Line Clearance at Production Area during Product to Product changeover and Batch to Batch changeover.

Line Clearance , Scope:

This SOP is applicable for the Production 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, Production

[][]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

[][]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 door, floor, walls and ceiling are cleaned.
[][]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 once daily.
[][]Ensure that production utensils like scoops, spatula, pallets, BMR table, tool boxes etc. 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.

Line Clearance during 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’.
[][]Ensure that floor is cleaned using vacuum cleaner and no visible traces of the previous batch material on the floor.

Annexure:

[][]N/A

Digital Weighing Balance, Purpose:

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

Digital Weighing Balance, Scope:

This SOP is applicable for 320 g & 60 Kg weighing balance for weighing of materials at the Production Area of XX Pharmaceuticals Ltd.

Definition / Abbreviation:

N/A.

Responsibilities:

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

Operator

[][]To follow the laid down procedure

Executive, Production

[][]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 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’ (Annexure – 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 accuracy check must be performed at the starting of the day.

[][]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 320 g Balances of Mettler Toledo :

To start up:

[][]Level and adjust at each time it is moved to a new location. The balance is exactly horizontal when the air bubble is in the middle of the level glass. Adjust the two front leveling feet appropriately until the air bubble comes to rest exactly in the middle of the glass.
[][]Plug the AC adapter and connect the power supply. Connect the printer to the balance (if available).
[][]Switch on the printer using I/O switch.
[][]Press On/Off ( ) button to on the Electric Analytical Balance. Display will show 0.000g.
[][]Convert the weighing unit from g into mg, press scroll down ( ) button if necessary.
[][]Allow the balance to warm up to enable it to adapt itself to the ambient condition.
[][]Long press for menu ( ) button and select ‘BASIC’ by single press Enter button ( ).
[][]Set date, time and unit using – /+ keys and Enter button ( ) and save the settings using ( ) button.
[][]Press cancel (C) button to return come out of that ‘BASIC’ option and return to its main menu.

[][]Perform the ‘Daily Accuracy Check’ (Annexure – I) at the starting of the day.

Weighing:

[][]Check the machine is clean and calibrated. Then remove all loads from weighing pan.
[][]When zero (0.000 g) reading is displayed, the balance is ready for operation. If the display shows greater than or less than zero, press tare ( O/T ) button to tare the balance.
[][]If the balance is not in the weighing mode, press and hold the ( ) key down until ‘WEIGHING’ in the display.

[][]Use handle/coupling element for the operation of the draft shield door of the both side of the instrument.
[][]Open right/left/upper sliding window of the instrument.
[][]Place empty container/weighing paper on the pan of the balance. Close the sliding window.
[][]The weight is displayed. Allow the reading to stabilize and wait until the instability detector (O) disappears from the left side of the display and the stability beep sounds.
[][]Press tare ( O/T ) button to tare the balance. When zero (0.000 g) reading is displayed, the balance is ready for weighing.
[][]The weighing-in aid is a dynamic graphic indicator which shows the used amount of the total weighing range. It can be recognized at a glance when the load on the balance approaches the maximum load.
[][]Add weighing sample (Maximum 320g) on the container/weighing paper using weighing spoon. Close the sliding window. The net weight is now displayed.
[][]Allow the reading to stabilize and wait until the instability detector (O) disappears for the display and the stability beep sounds.
[][]To get printout of the weight, press print ( ) button.

[][]For performing another weighing press tare ( O/T ) button to tare the balance and follow steps from previous steps To increase or decrease digit, press display resolution ( ) button.
[][]Finally, press and hold On/Off button ( ) button until ‘SHUT OFF’ shows on the display.

Calibration:

Internal Calibration:

[][]Manual Adjustment with Internal weight:
[][]Long press menu ( ) button and press scroll down ( ) button to go to ‘ADVANCED’ option.
[][]Select ‘ADVANCED’ by pressing Enter ( ) button.
[][]Press scroll down ( ) button once to select ‘CAL’ option by pressing Enter ( ) button.
[][]Then select ‘ADJ. INT’ using scroll down ( ) button and then press Enter ( ) button.
[][]Press cancel (C) twice and save the settings if required by scrolling down ( ) button and press Enter ( ) button and then return to its main menu.
[][]Unload weighing pan Press and hold calibration ( ) button to execute ‘Internal Adjustment’.
[][]The balance adjusts itself automatically. The adjusting is finished when the message “ADJ.DONE” appears briefly on the display. The balance returns to the last active application and is ready for operation.

[][]After adjustment, the result of the calibration will be printed out automatically or press print ( ) button for print copy.

External Calibration:

[][]Manual Adjustment with External weight:
[][]Follow the instruction from previous steps
[][]Select ‘ADJ. EXT’ by using scroll down ( ) and then press Enter ( ) button.
[][]Set the adjustment weight (100g) by using -/+ key for External Calibration and press Enter ( ) button.

[][]Then press cancel (C) button twice and save the settings if required by using -/+ key and press Enter ( ) button and then return to its main menu.
[][]Unload weighing pan Press and hold calibration ( ) button to execute ‘External Adjustment’.
[][]The required predefined adjustment weight value flashes on the display.
[][]Place adjustment certified weight on the center of pan. The balance adjusts itself automatically.
[][]When ‘0.00 g’ flashes, remove the adjustment weight.
[][]The adjustment is finished when the message ‘ADJ DONE’ appears briefly on the display. The balance returns to the last active application and is ready for operation.
[][]After adjustment, the result of the calibration will be printed out automatically or press print ( ) button for print copy.

Operation of 60 kg Balances of Mettler Toledo:

[][]Using an 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).

Without using an Empty 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.
[][]Perform the ‘Daily Accuracy Check’ (Annexure – I) at the starting of the day.

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 routine calibration half year. 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: Digital Weighing Balance

Annexure I – Daily Accuracy Check.

Monitoring of Room Condition, Purpose:

Monitoring of Room Condition, To lay down the procedure for monitoring of Temperature, Relative Humidity (%) and Pressure Gradient at the Production Area.

Monitoring of Room Condition, Scope:

This SOP is applicable for the Production Area of General Block of the XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

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

Operator

[][]To follow the laid down procedure

Executive, Production

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

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure :

Precaution :

[][]Do not use a new hygrometer unless it is calibrated.
[][]When any hygrometer is shifted from one location to another, allow to stabilize the device prior to record the temperature / Relative Humidity (%).
[][]Check the due date of calibration of the hygrometer and magnehelic gauge before taking reading.
[][]Ensure that temperature and Relative Humidity (%) readings are taken before going to operation.

[][]Temperature and Relative Humidity (%) (using Digital Hygrometer)
[][]Ensure that no dust is accumulated over the sensor.
[][]Read the temperature and relative humidity (%) values displayed on the screen of digital/analog hygrometer and record in ‘Temperature, Relative Humidity (%) & Pressure Gradient Records’ (Annexure-I).
[][]Acceptance Criteria:

Area	Temperature	Relative Humidity (%)
Dispensing, Material Staging, Dispensed Material Staging, D Corridor, Wash Bay, Clean Equipment, Broken Bulk, FBD Bag Store, Solution Preparation, Clean Equipment, Encapsulation, WIP Granules, WIP Tablet & Capsules, Coating, Tools Storage, Office Room, Coating Solution Preparation, D Dress Washing & Drying, Foil/Film Staging, Blister Packaging and Dry Syrup Filling & Sealing.	Not more than (NMT) 25°C	Not more than (NMT) 60 %
Granulation, Blending, Tablet Compression.	Not more than (NMT) 25°C	Not more than (NMT) 45%

Pressure Gradient

[][]Read the pressure differential from magnehelic gauge provided and record.
[][]If the reading is not within limit, check whether all the doors are closed.
[][]Observe the second reading.
[][]Even if the second reading is not within the limit, inform the Engineering department for corrective action.

Area	Pressure Differential
Processing Units Negative with respect to corridor (i.e. Air Flow is from corridor to processing unit)	10 – 20 Pascal
Wash Bay Positive with respect to Corridor (i.e. Air Flow is from Wash Bay to Corridor)	10 – 20 Pascal

Frequency

[][]Twice in a shift, first before starting the operation and second after four hours.
[][]If the reading is not within limit at any time of operation, inform the Engineering department immediately and take following steps in different areas.
[][]At Dispensing area stop weighing process, close the bags / high density polyethylene (HDPE) drums of raw materials.
[][]At Granulation area, stop transfer process of materials if running and close the SS / HDPE container with lid.
[][]Do not discharge if temperature and relative humidity (%) or pressure gradient are not within limit.
[][]At Blending area, continue blending process if already running.
[][]At Compression area, stop operation and close the tablet SS/HDPE container lid. Do not keep the granules in the hopper during overnight.
[][]Empty the hopper and close the lid of SS / HDPE container.
[][]At Encapsulation area, stop operation and close the capsule SS/HDPE container lid. Do not keep the granules / pellets in the hopper during overnight. Empty the hopper and close the lid of SS/ HDPE container.

[][]At Coating area, continue operation if already running, otherwise stop operation. Do not unload if temperature and relative humidity (%) or pressure gradient are not within limit.
[][]At Powder filling area, stop the operation. Do not keep the granules in the hopper during overnight.
[][]Empty the hopper and close the lid of SS / HDPE container.
[][]At Blister Packing area, close the lid of tablet / capsule container, close the hopper with lid and stop further operation.

Annexure:

Annexure I – Room Condition Monitoring Logbook