Friday, May 29, 2009

Vibrating Sifter

PURPOSE

It is established to provide a proper procedure for sifting of material through vibration.

SCOPE

It is applicable in Granulation Section.

RESPONSIBILITY

Maintenance officer (Mechanical / Electrical)
Maintenance Supervisor (Mechanical / Electrical)

PROCEDURE

The Vibrating Sifter with instrument is handled in the following way.

MAINTENANCE

MONITORING OF MACHINE MAINTENANCE:

Time to time check each and every part of Vibrating Sifter according to the maintenance schedule. Check the following parts carefully.
vElectric motor
vElectric Contactor
vShaft & Bearings
vVibrating Rubber
vMesh
This activity is then documented in the form Machinery & Equipment Maintenance Log Check the Vibrating Sifter condition time to time to find any kind of problem during EMERGENCY / BREAKDOWN MONITORING:
Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.
Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register .
Maintenance Manager assigns the maintenance work to the concerned personal
After the completion of work the section incharge signs the completion of Work Order.
All the record is filed and kept by the Maintenance Supervisor.


PRECAUTION:

If find any problem in the alignment of the machine stop over the procedure.
If find any kind of abnormal noise, immediately stop the machine and maintain it.
operation. All the monitoring record is filed and kept by the Maintenance Supervisor.

Nitrogen Delivery Apparatus

PURPOSE

It is established to provide a proper procedure of nitrogen delivery procedure in the Ampoule/Vial filling department.

SCOPE

It is applicable in the Ampoule/Vial filling department.

RESPONSIBILITY

Maintenance officer (Mechanical)
Maintenance Supervisor (Mechanical)

PROCEDURE

The Nitrogen Delivery Apparatus with instrument is handled in the following way.

MAINTENANCE

MONITORING OF MACHINE MAINTENANCE:

Time to time check each and every part of Nitrogen Delivery Apparatus to according to the maintenance schedule. Check the following parts carefully.
vFilters
vS , S Bolts
vS , S Legs
This activity is then documented in the form Machinery & Equipment Maintenance Log Check the Nitrogen Delivery Apparatus condition time to time to find any kind of All the monitoring record is filed and kept by the Maintenance Supervisor.
EMERGENCY / BREAKDOWN MONITORING:

Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.
Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register.
Maintenance Manager assigns the maintenance work to the concerned personal
After the completion of work the section incharge signs the completion of Work Order.
All the record is filed and kept by the Maintenance Supervisor.


PRECAUTIONS:

Always handled by trained staff.
problem during operation.

Electric Left

PURPOSE

It is established to provide a proper procedure for transportation of different items.

SCOPE

It is applicable in production department.

RESPONSIBILITY

Maintenance officer (Mechanical / Electrical)
Maintenance Supervisor (Mechanical / Electrical)

PROCEDURE

The Electric Lift with instrument Code No. EL-274 is handled in the following way.

MAINTENANCE

MONITORING OF MACHINE MAINTENANCE:
Time to time check each and every part of Electric Lift according to the maintenance schedule. Check the following parts carefully.
vElectric Motor
vGear Box
vElectric Brake & required adjustment
vCarriage Wheel (if required alignment)
v Limit Switches
vElectric Switches
vMagnetic Contactor & relay
vElectric Control Circuit
vRope
This activity is then documented in the form Machinery & Equipment Maintenance Log Check the Electric Lift condition time to time to find any kind of problem during operation.
All the monitoring record is filed and kept by the Maintenance Supervisor.

EMERGENCY / BREAKDOWN MONITORING:

Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.
Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register .
Maintenance Manager assigns the maintenance work to the concerned personal
After the completion of work the section incharge signs the completion of Work Order.
All the record is filed and kept by the Maintenance Supervisor.

PRECAUTIONS:
During operation if feel any abnormal noise stop the machine.
When the door is open lift should not start.
Pullies & Bearings

Dust Collector

PRINCIPLE

Pharmaceutical products can be contaminated by dust. Dust not only pollutes the equipment and machinery used in the production area but also cause dangerous alarms to the pharmaceutical products as well.

PURPOSE

This Standard Operational Procedure is established to provide a proper procedure for the handling and working of dust collector.

SCOPE

It is applicable in the production area.

RESPONSIBILITY

Maintenance officer (Mechanical / Electrical)
Maintenance Supervisor (Mechanical / Electrical)

PROCEDURE

The Dust Collector with instrument is handled in the following way.


MAINTENANCE

MONITORING OF MACHINE MAINTENANCE:

Time to time check each and every part of Dust Collector according to the maintenance schedule. Check the following parts carefully.
vElectric Motor
vVibrating Sifter
vMagnetic Contactor
vTimer & relay
vvWash the filter thoroughly
This activity is then documented in the form Machinery & Equipment Maintenance Log
Check the Dust Collector condition time to time to find any kind of problem during operation.
All the monitoring record is filed and kept by the Maintenance Supervisor.

EMERGENCY / BREAKDOWN MONITORING:

Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.
Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register . Maintenance Manager assigns the maintenance work to the concerned personal
After the completion of work the section incharge signs the completion of Work Order.
All the record is filed and kept by the Maintenance Supervisor.

PRECAUTIONS:

Immediately stop the machine, whenever feel any kind of abnormality during operation.
The machine should be handled by the trained operator. Bearings & Blower

Dispensing Hood

PURPOSE

It is established to provide a proper procedure for dispensing of Raw Material.

SCOPE

It is applicable in Raw Material Store.

RESPONSIBILITY

Maintenance officer (Mechanical / Electrical)
Maintenance Supervisor (Mechanical / Electrical)


PROCEDURE

The dispensing hood with instrument is handled in the following way.

MAINTENANCE

MONITORING OF MACHINE MAINTENANCE:

Time to time check each and every part of Dispensing Hood according to the maintenance schedule.
Check the following parts carefully.
vBlower motor
vU.V. Light
vFilter
vHepa Filter
vBlower, Shaft , Bearing etc.
vElectric switches and panel
Check the Dispensing Hood condition time to time to find any kind of problem during operation.
All the monitoring record is filed and kept by the Maintenance Supervisor.

EMERGENCY / BREAKDOWN MONITORING:

Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.
Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register
Maintenance Manager assigns the maintenance work to the concerned personal
After the completion of work the section incharge signs the completion of Work Order.
All the record is filed and kept by the Maintenance Supervisor.


PRECAUTION:

The trained operator should handle the machine. This activity is then documented in the form Machinery & Equipment Maintenance Log

Dehumidifier

PURPOSE

It is established to provide a proper procedure of controlling humidity in the manufacturing department.

SCOPE

It is applicable in the Capsule/Tablet manufacturing department.

RESPONSIBILITY

Maintenance officer (Mechanical / Electrical)
Maintenance Supervisor (Mechanical / Electrical)

PROCEDURE

The Dehumidifier machine with instrument is handled in the following way.

MAINTENANCE

MONITORING OF MACHINE MAINTENANCE:

Time to time check each and every part of Dehumidifier according to the maintenance schedule. Check the following parts carefully.
vProper Working of fan
vProper working of Compressor
vWash the condenser
vBearings
vElectric Panel
This activity is then documented in the form Machinery & Equipment Maintenance Log
Check the Dehumidifier condition time to time to find any kind of problem during All the monitoring record is filed and kept by the Maintenance Supervisor.

EMERGENCY / BREAKDOWN MONITORING:

Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.
Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register
Maintenance Manager assigns the maintenance work to the concerned personal
After the completion of work the section incharge signs the completion of Work Order.
All the record is filed and kept by the Maintenance Supervisor.


PRECAUTION:

Trained staff should handle dehumidifier.peration.

Calibration of Temperature Gauges and Temperature Controllers

PURPOSE

To established a procedure for the calibration of temperature gauge & temperature controller.

SCOPE

This procedure covers all temperature gauges & temperature controllers being calibrated by Siza personal.

EQUIPMENT USED

Calibrated Digital Temperature Indicator.
Oil Bath with Electric Heater.

PROCEDURE

The Temperature Gauge & Temperature Controllers is handled in the following way.


Not down all relevant information of instrument in the data sheet.
Now clean the gauge for any stain or rust.
Now increase the temperature of the oil bath system regarding to the gauge to be calibrated and fix the gauge in the oil bath and sensor of the digital temperature indicator, leave it for some time to maintain its temperature.
Now check the Temperature gauge reading & Digital Temperature Indicator Reading.
The gauge is to be calibrated on three times approximately or at the temperature ranged used normally in the system.
Note down the temperature reading of first set point in the column marked “READ VALUE”. In the data sheet.
Note down the reading on the standard instrument in the column marked “TRUE VALUE” in the data sheet.
Repeat steps for next set point and note the readings in the respective Calculate the deviation by subtracting the READ value from the TRUE value, and enter the deviation in the column marked “DEVIATION” in the data sheet.
Now analyze the deviation. If the deviation is out of the specified deviation of the temperature gauge is to be adjusted until the deviation comes within required deviation. If after adjustment deviation does not come within specified deviation stop calibration and replace the instrument with new one and calibrate it again and fill the final inspection sheet accordingly.
If the deviation within specified deviation affix the calibration sticker on the temperature gauge or temperature controller and submit the data sheet to Maintenance Manager.
Calibration engineer prepare the calibration sheet and submit to Maintenance Manager.
The record sheet is sign by concern calibration Engineer.lumns in the data sheet.

Thursday, May 28, 2009

Battery Operated Lefter

PURPOSE

It is established to provide a proper procedure for loading & unloading.

SCOPE

It is applicable in Infusion Autoclave Department.

RESPONSIBILITY

Maintenance officer (Mechanical / Electrical)
Maintenance Supervisor (Mechanical / Electrical)

PROCEDURE

The Battery Operated Lifter with instrument Code is handled in the following way.


MAINTENANCE

MONITORING OF MACHINE MAINTENANCE:

Time to time check each and every part of Battery Operated Lifter according to the maintenance schedule. Check the following parts carefully.
vBattery
vBattery water level
vBattery Charger
vBearings
vJack Motor
vSeals
Check the Battery Operated Lifter condition time to time to find any kind of problem during operation.
All the monitoring record is filed and kept by the Maintenance Supervisor.

EMERGENCY / BREAKDOWN MONITORING:

Maintenance Manager receives Maintenance Work Order (duly signed by the section incharge of the concerned machinery or equipment.
Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register
Maintenance Manager assigns the maintenance work to the concerned personal
After the completion of work the section incharge signs the completion of Work Order.
All the record is filed and kept by the Maintenance Supervisor.

PRECAUTIONS:

Always handled by the trained operator.vChain & Shaft

Balance

PURPOSE

It is established for the proper measurement of weight of raw material & pharmaceutical products.

SCOPE

This is applicable to the Quality Control & Warehouse Department.
RESPONSIBILITY

Maintenance officer (Mechanical / Electrical)
Maintenance Supervisor (Mechanical / Electrical)

PROCEDURE

The Balance is handled in the following way.

CLEANING:

Clean the pan of the weighing balance with dry and clean duster.

OPERATION:

Put the power plug in the socket and switch it “ON”.
Switch “ON” the apparatus and confirm its “ON” position by observing 0.00g on displaying screen. Press on if “Tare” required.
Place the sample on the weighing pan.
Note the weight from the displaying screen and remove the sample form the pan.
After weighing again clean with dry and clean duster.
PRECAUTIONS:

Install the balance on a vibration free place.
Check all the circuits before use.Handle the apparatus with care.

Thursday, May 21, 2009

Storage and handling of finished product

1. PURPOSE

1.1 It is established to ensure the proper storage and handling to prevent finished product from damage and deterioration.

2. SCOPE

2.1 It is applicable for storage and handling of all kinds of finished product in FINISHED GOODS STORE.

3. RESPONSIBILTY
3.1 INCHARGE (Finished Goods Store)
3.2 Supervisor finished goods store
3.3 Helper

4. PROCEDURE

Process of Storage and Handling

4.1.1 The finished products must be stored in the specified area under controlled conditions that is humidity, not more than 70% and temperature not more then 30 °C. Protect from direct sun light.
4.1.2 The outer carton containing finished products must be stacked in the following manner so that carton/product is not damaged.

Outer Carton No.
Total No. of Outer Carton Stacked





4.1.3 The product must bear its Name, Batch No., Batch Size and quantity on the outer carton.

4.1.4 During transportation of the finished product, it should be handled with care to avoid breakage, damage, and leakage.

4.1.5 Stock rotation of all the batches must be maintained in the finished good store according to the first in first out formula.

4.1.6 All the storage and handling must be carryout through authorized persons under the supervision of finished good storekeeper.

4.1.7 Entry of unauthorized persons must be prohibited by the finished good storekeeper.

4.1.8 The finished goods store should be neat and clean.

recieving of finished goods

1.0 PURPOSE

1.1 The purpose of this standard procedure is to establish an effective system of finished goods receiving.
2.0 SCOPE

2.1 It is applicable in Finished Goods Store.

3.0 RESPONSIBILITY

3.1 F.G. Store Incharge
3.2 F.G supervisor
3.3 Helper
4.0 GENERAL PROCEDURE

4.1 F.G. Store Incharge receives finished gods along with transfer description sheet (QR/PN/029/01)from the production department.
4.2 F.G. Store Incharge enters the finished goods in RECEIVING REGISTER.
4.3 F.G. Store Incharge puts up the entry of the finished goods in the relevant RECEIVING REGISTER i.e com,p/s or institutional.
4.4 F.G. Store Incharge Checks the product,Batch no.,Mo no.,pack size and quantity etc carefully.
4.5 F.G. Store supervisor rechecks the product,Batch no.,Mo no.,pack size and quantity etc carefully.
4.6 Then the finished product is arranged in the assigned rack cleanly.
5.0 PRECAUTIONS

5.1 Every finshed drug recievining should be documented.
5.2 Every finished drug should be placed in a separate identified area.
5.3 Every activity performed with the finished drug should be documented according to the sop strictly.

recieving of finished goods

1.0 PURPOSE

1.1 The purpose of this standard procedure is to establish an effective system of finished goods receiving.
2.0 SCOPE

2.1 It is applicable in Finished Goods Store.

3.0 RESPONSIBILITY

3.1 F.G. Store Incharge
3.2 F.G supervisor
3.3 Helper
4.0 GENERAL PROCEDURE

4.1 F.G. Store Incharge receives finished gods along with transfer description sheet (QR/PN/029/01)from the production department.
4.2 F.G. Store Incharge enters the finished goods in RECEIVING REGISTER.
4.3 F.G. Store Incharge puts up the entry of the finished goods in the relevant RECEIVING REGISTER i.e com,p/s or institutional.
4.4 F.G. Store Incharge Checks the product,Batch no.,Mo no.,pack size and quantity etc carefully.
4.5 F.G. Store supervisor rechecks the product,Batch no.,Mo no.,pack size and quantity etc carefully.
4.6 Then the finished product is arranged in the assigned rack cleanly.
5.0 PRECAUTIONS

5.1 Every finshed drug recievining should be documented.
5.2 Every finished drug should be placed in a separate identified area.
5.3 Every activity performed with the finished drug should be documented according to the sop strictly.

FGl Store cleaning

1.0 PRINCIPLE

In the process of receiving, issuing and dispensing lot of dust is created which settles and contaminates the whole area . This dust may be harmful if inhaled by the person sitting or working around the dispensing table. Also in all probability the dust settles in the neighboring containers / materials that may cause cross contamination. Therefore it is necessary that utmost care be taken in cleaning the whole area around the storage place. Following are the guidelines for cleaning.

2.0 PURPOSE

2.1 This standard operating procedure outlines the proper procedure to clean the FINISHED GOODS STORE.
3.0 SCOPE
3.1It is applicable in the FINISHED GOODS STORE.

4.0 RESPONSIBILITY

4.1 Finished goods Incharge
4.2 Finished foods supervisor
4.3 Housekeeping Staff

5.0 PROCEDURE

A. PACKING, RAW MATERIAL STORES

v Collect the dust settled over tables, floors, containers, etc. by using vacuum cleaner.
v Vacate the empty pallets / containers from the areas or from the racks and wipe the dust with a cotton cloth or duster.
v Sweep the floor thoroughly.
v Use the wet mop for through cleaning of the floor. Use 1% Teepol or liquied soap (about 100 l in 10 litres of tap water) for wet mopping followed by swabbing by fresh tap water.
v To maintain suitable record to alert and update the activities.

B. DAILY CLEANING PROCEDURE

v Daily clean the floors, walls and racks etc. according to the sop of sanitation.
v Maintain the daily sanitation record ,concluding three times cleaning.



C. WEEKLY CLEANING PROCEDURE

v Collect the dust settled over the office equipments furniture, fixtures and walls by using blower cum vacuum cleaner.
v Wipe the dust with a dry duster.
v Sweep the floor thoroughly.
v Use a wet mop for cleaning the floor.

D. CLEANING ONCE IN THREE MONTHS

v Vacate palletized materials from the stores. Collect the dust by using vacuum.
v Clean the ceiling of the whole area of stores including racks, shelves, walls and ceiling.
v Wipe the racks / walls with dry cloth duster.
v Sweep the floor.
v Add 100 g Caustic Soda to 10 litres of tap water for cleaning the floor. Mop the floor with this solution.
v Wipe the floor with 1% Teepol solution
v Apply pest control insecticides around the stores.
v Replace material in their designed location.

F. ADDITIONAL PRECAUTIONS

v Ensure that all the received goods are in clean condition. If not, arrange to get them cleaned before placing them in their designated locations. If goods are received in an unclean container, isolate and transfer into clean containers, ensuring appropriate labeling.

Drug Returns and proper management of returned drugs.

1.0 PURPOSE

1.1 The purpose of this standard procedure is to establish an effective system of Drug Returns and proper management of returned drugs.
2.0 SCOPE

2.1 It is applicable in Finished Goods Store.

3.0 RESPONSIBILITY

3.1 Q.C. Manager
3.2 F.G. Store Incharge
3.3 Account Department
4.0 GENERAL PROCEDURE

4.1 F.G. Store Incharge receives returned drugs along with covering letter from the marketing office.
4.2 F.G. Store Incharge enters the returned drugs on the stores return voucher QR/028/01.
4.3 F.G. Store Incharge puts up the entry of returned drugs along with return voucher No. in the return Bin Cards.
4.4 F.G. Store Incharge Checks the reason of return stated on covering letter and takes the corrective measure as follows.
4.4.1 If the returned drug is expired, it is requested to destroy and following the procedure, it is destroyed properly.
4.4.2 If the returned drug is claimed for potency, F.G. Store Incharge requests Q.C. for analytical report.
4.4.3 After the arrival of Q.C. Analytical Report F.G. Store Incharge handles the drugs accordingly.
4.4.4 F.G. Store Incharge reports the finance department which makes the credit note against the return voucher in the name of customer if needed.
4.4.5 The replacement of drug is done according to the company policy.

5.0 PRECAUTIONS

5.1 Every drug to be returned should be documented.
5.2 Every drug to be returned should be placed in a separate identified area.
5.3 Every drug to be destroyed should be kept under lock and key with proper documentation.
5.4 Every activity performed with the returned drug should be documented according to the sop strictly.

system of dispatch.

1.0 PURPOSE

1.1 The purpose of this standard operating procedure is to establish an effective system of dispatch.
2.0 SCOPE

2.1 It is applicable in Finished Goods Store.

3.0 RESPONSIBILITY

3.1 F.G. Store Incharge
3.2 F.G supervisor
3.3 Helper
4.0 GENERAL PROCEDURE

4.1 F.G. Store Incharge receives GS ORDER INFORMATION from marketing office.
4.2 F.G. Store Incharge allocates the batch numbers of the products to be dispatched against the GS ORDER INFORMATION.
4.3 F.G. Store Incharge prepares THE PACKING LIST(QR/FGS/005/01)against the order.
4.4 F.G.StoreIncharge allocate the serialno.to the THE PACKING LIST(QR/FGS/005/01)against the order.
4.5 F.G. Store supervisor rechecks the PACKING LIST(QR/FGS/005/01) carefully.
4.6 Then the finished product is arranged for dispatch cleanly.
4.7 A POSTED NO.is assigned to every dispatch.
4.8 A copy of PACKING LIST Iis filed and the other is send to the party.
4.9 Account branch is then intimated through GI NO.
4.10 In case of shortage of any product THE REPEAT ORDER is followed.
5.0 PRECAUTIONS
5.1 Every finshed drug dispatch should be documented
5.2 Every activity performed with the finished drug should be documented according to the sop strictly.

system of dispatch.

1.0 PURPOSE

1.1 The purpose of this standard operating procedure is to establish an effective system of dispatch.
2.0 SCOPE

2.1 It is applicable in Finished Goods Store.

3.0 RESPONSIBILITY

3.1 F.G. Store Incharge
3.2 F.G supervisor
3.3 Helper
4.0 GENERAL PROCEDURE

4.1 F.G. Store Incharge receives GS ORDER INFORMATION from marketing office.
4.2 F.G. Store Incharge allocates the batch numbers of the products to be dispatched against the GS ORDER INFORMATION.
4.3 F.G. Store Incharge prepares THE PACKING LIST(QR/FGS/005/01)against the order.
4.4 F.G.StoreIncharge allocate the serialno.to the THE PACKING LIST(QR/FGS/005/01)against the order.
4.5 F.G. Store supervisor rechecks the PACKING LIST(QR/FGS/005/01) carefully.
4.6 Then the finished product is arranged for dispatch cleanly.
4.7 A POSTED NO.is assigned to every dispatch.
4.8 A copy of PACKING LIST Iis filed and the other is send to the party.
4.9 Account branch is then intimated through GI NO.
4.10 In case of shortage of any product THE REPEAT ORDER is followed.
5.0 PRECAUTIONS
5.1 Every finshed drug dispatch should be documented
5.2 Every activity performed with the finished drug should be documented according to the sop strictly.

DESTRUCTION OF EXPIRED DRUGS

1.0 PURPOSE

1.1 The purpose of this standard procedure is to establish an effective system for proper management and destruction of expired drugs.
2.0 SCOPE

2.1 It is applicable in Finished Goods Store.
3.0 RESPONSIBILITY

3.1 Director
3.2 Q.C. Manager
3.3 Production Manager
3.4 F.G. Store Incharge
3.5 Account Department
4.0 GENERAL PROCEDURE

4.1.1 The expired returned drug received from marketing office is entered to the store return voucher (QR/028/01).
4.1.2 Then the returned expired drug is entered in Bin Card (QR/007/01).
4.1.3 F.G. Store Incharge prepare the destruction sheet (QR/FG/015/01).
4.1.4 The destruction sheet (QR/FG/015/01) is then approved by Q.C. Manager, Production Manager and Director.
4.1.5 The expired returned drugs are then destroyed in the presence of F.G. Store Incharge, Q.C. Manager, Production Manager as follows:
Sr.#
Dosage Form
Method of Destruction
01
Solid Dosage Form
De-blistering, crushing, drain with the sufficient quantity of water
02
Liquid Dosage Form
Glass destruction, solution drainage with sufficient quantity of water.

5.0 PRECAUTIONS

5.1 Every expired returned drug should be documented.
5.2 Every drug to be destroyed should be placed in a separate identified area.
5.3 Every drug to be destroyed should be kept under lock and key with proper documentation.
5.4 Every activity performed with the expired returned drug should be documented according to the sop strictly.The record of destruction should be maintained properly

Supplier Approval

1.0 PURPOSE

1.1 It is established to provide a proper procedure for the approval of new suppliers, evaluation and re-evaluation of existing suppliers who are directly involved in providing raw and packaging materials.
2.0 SCOPE

It is applicable in purchase department.
3.0 RESPONSIBILITY

3.1 Director Operations Manufacturing
Management Representative
Quality Control Manager

4.0 PROCEDURE

Approval Of A New Supplier:

4.1 Evaluate a new supplier on the basis of following mentioned tips:
1 Make sure they can provide material(s) according to the specifications.
2 They are bound to reference of some other company or group of companies where they are already doing business.
3 Check the market stability of the party as well as the source from where they are taking material(s).
4 Punctuality in delivering material(s).
5 Ask them how long they can maintain a proper flow of material(s) with consistent quality and quantity.
6 Financial Stability
7 Market Repute
4.2 After fulfilling the above mentioned criteria ask the party to send samples of the required material(s).
4.3 Analyze the samples according to the Siza’s specifications.
4.4 First three consignments must be taken as trial of a supplier, if Quality Control passes the three consignments simultaneously then the supplier will be able to continue the supply of desired material(s) as a permanent supplier.

Evaluation and Re-Evaluation:

4.5 Once the company approves a supplier then it is very important to re-evaluate the performance of that supplier after every year to get the best possible results.
4.6 Approved suppliers can be re-evaluated by using the supplier evaluation and re-evaluation form.
4.7 All the required parameters for the re-evaluation have been defined in the form.
4.8 In case of poor performance company will intimate the supplier to improve the quality of the supplied materials otherwise company has the right to discontinue the contract without prior notice.

dispensing and issuance of approved raw material

1.0 PURPOSE

1.1 This standard operating procedure outlines the method for the dispensing and issuance of approved raw material requested for processing by the production department on relevant manufacturing orders.

2.0 SCOPE

2.1 It is applicable in Warehouse Department.

3.0 RESPONSIBILITY

3.1 Warehouse Incharge
3.2 Warehouse Officer
3.3 Production Officer
3.4 Quality Control Officer

4.0 PROCEDURE

Ø Before commencing the dispensing, check that:

1 Dispensing area is clean.
v Dispensing table is clean.
v No raw materials of the previous weighing are lying in the dispensing area.
v The weighing balance is clean and calibrated. (The calibration should be properly recorded on the weighing balance calibration sheet attached to the balance).
v The weighing accessories i.e. scoops spatulas are properly cleaned.
v The protective garments i.e. gloves and face masks are available and the personnel engaged in dispensing and checking is wearing them.
v The rubber gloves are provided for the dispensing of potent drugs.
v The required relative humidity is present and a daily record is being maintained.
v Only one raw material is brought at one time for dispensing.
v The spillages are removed at once and the exhaust system is properly working.

Ø The Bin cards should be properly maintained for all raw materials and FIFO policy should not be disturbed at any time.
Ø The dispensing should be done by the warehouse officer or his designate for proper and accurate dispensing a cross check system of the weighed / dispensed materials is made and recorded.
Ø The dispensing should only be done after thorough checking of the manufacturing order for the Product’s name, Code No. M.O. No. Batch No., Batch Size and Date.
Ø The dispensing of any raw material should not be made prior to checking the condition of the container; the Q.C. released label and revalidation date as well as the properly maintained warehouse label or tag. Every container must be resealed like original after dispensing.
Ø The raw materials must be weighed very carefully on a balance of appropriate accuracy in appropriate containers after checking their tare weights.
Ø Each raw material must be checked for its physical appearance order and presence of any foreign substance or particles. If the appearance is doubtful or it contains extraneous material or particles it should not be issued for processing but should be immediately quarantined and referred to the Quality Control Department for re-checking.
Ø The raw material must be issued against the Lot No. or A. No. any material of two different lots should be weighted separately and issued in separate should area be recorded on the manufacturing order.
Ø After completing the dispensing of every individual item the issued Qty. a Lot No., weighed by and checked by columns of the manufactured order must be properly initialed.
Ø All raw materials issued against any manufacturing order must be kept separately in an area un-accessible to the unauthorized personnel or under lock and key.

purchase raw and packing material

1.0 PURPOSE

1.1 This standard operating procedure outlines the method for the purchasing.
2.0 SCOPE

2.1 It is applicable in Purchase Department.
3.0 RESPONSIBILITY

3.1 Warehouse Officer
3.2 Purchase Officer
4.0 PROCEDURE

Ø For some types of materials (like excipients, shippers etc.) purchase order is raised by the department and approved from director and sent to the supplier directly.
Ø For purchase of machinery purchased order is raised against already approved quotations and sent to the supplier.
Ø For printed packing materials like cartons, labels and leaflets etc; demand is sent to Executive Director in the form of printing order through general admin. Executive Director decides which printer will print the packing material.
Ø Sectional Incharge raises the purchase demand on triplicate purchase demand book (QR / CW / 003 / 01) for miscellaneous item.
Ø Head of the department verifies the demand.
Ø Director approves the demand.
Ø Purchaser goes to the market and purchases the materials and goods from already approved suppliers.
Ø Raw Material ware house officer receives the materials & goods and sends request to Q.C. for testing of raw materials & packing materials and prepares GRR(QR / RMS / 004 / 01).
Ø Miscellaneous items are physically checked by the warehouse officer.
Ø Warehouse Officer issues the materials to relevant departments on indent book (QR / CW / 012 / 01) and packing material requisition book(QR / PN / 017 / 01) and raw material requisition book (QR / PN / 022 / 01).

Dispensing equipment cleaning

1.0 PRINCIPLE

Pharmaceutical products can be contaminated by other pharmaceutical products, by cleaning agents, by micro-organisms or by other materials (e.g. dust, lubricants, raw materials, intermediates etc.) In many cases, the same equipment may be used for processing different products. To avoid contamination, adequate cleaning procedures are essential.

2.0 PURPOSE

1.1 This standard operating procedure outlines the proper procedure to clean the dispensing equipments e.g. scoops, spatulas and utensils etc.
3.0 SCOPE

3.1 It is applicable in the Raw Material Store.

4.0 RESPONSIBILITY

4.1 Warehouse Incharge
4.2 Warehouse Officer
4.3 Dispensing Supervisor

5.0 PROCEDURE

1 For every drug substance dedicated equipment (Scoop, spatulas, etc.) are used.
2 Dispensing equipment used for excepients is not dedicated; however, cleaning procedure for all the equipment is same.
3 Immediately after completing the dispensing operation, the dispensing equipment is carefully wrapped in a polythene bag and placed in a plastic box that has been labeled, used scoops / spatulas for cleaning.
4 After completing the dispensing operation, the dispensing equipment contained in the box is removed from dispensing area for cleaning. The operator should wear rubber gloves before commencing cleaning.
5 Equipment is scrubbed with 2% teepol solution and rinsed under running tap. To remove sticky substances, the equipment are rinsed with hot water and scrubbed with 2% teepol solution. After rinsing under running tap water, the equipment is rinsed with distilled water and allowed to drain. Then the equipment is sprayed with 70% Isopropyl Alcohol and dried.
6 The cleaned and dried equipment is wrapped in aluminum foil and covered with Kraft paper. A label “I AM CLEAN” is affixed.
7 The ready to use equipment is stored in a closed box for future use.

cross contamunation raw material

1.0 OBJECTIVE

One of the most critical aspects of dosage from manufacture is the vigilance and care required ensuring the complete absence of any form of cross contamination. Detailed hereunder are the different controls at the various stages:

2.0 PURPOSE

v This standard operating procedure outlines the proper procedure to check the cross contamination in the best possible way.
3.0 SCOPE

v It is applicable in the Raw Material Store, Finished goods store, Production departments.

4.0 RESPONSIBILITY

v Warehouse Incharge
v Production Manger
v Section Incharge

5.0 PROCECUREMENT

1 The purchase and quality control personnel conduct a systematic vendor evaluation.This includes a detailed inspection of the suppliers factory, the main purpose of which is to identify any potential source of cross contamination of substances supplied.
2 If the manufacturing location is manufacturing more than one item, periodically the QC department will attempt to identify the presence of the contaminant in the item purchased.
3 The procedure followed in the production of packing components, particularly the intimate packaging items ( tubes , vials, laminate ) is carefully studied by the QC team, essentially with a view to track any residual contaminant e.g. mould lubricant, metal filling etc.

6.0 RECEIVING AND STORAGE

4 The staff responsible for clearing and forwarding are “educated “on the importance of inspecting the cargo to identify if there is any evidence of contamination.
5 There is a very strong possibility of improper storage , whereby, material purchased is accidentally contaminated by the contents of other customs hold area.
6 A similar vigilance is required to exercised by all personnel responsible in the company for storage at different stages/locations. Periodically the statutory agencies, particularly the import control department requires samples to drawn.
7 Unless these samples are drawn carefully in QC personnel for such sampling.
8 The stores personnel will verify with QC suitability of containers if the contents from the original
7.0 DISPENCING
v The SOP for dispensing of materials needs to be religiously followed to prevent any cross contamination.
8.0 COMPOUNDING
v Apart from the prescribed SOP,s supervisors concerned will pay attention to the condition of garments worn by the operators and cleanliness of the various accessories, including scoops, spatulas etc.
v Particular attention will be required to ensure that the crevices, gaskets etc. are free from any contaminant.
v Dust control equipment must invariably be validated to confirm its capability to pick up errant material.
v Periodic chemical testing of the rinse from cleaned equipment will further increase confidence of cross contamination control.
9.0 WORK IN PROCESS
v These areas should be secured and accessible to the authorized personnel.
v Standard good manufacturing practices (GMP) and routine sanitary control and inspection will eliminate potential hazards.
v Prolonged hold needs to be discouraged/eliminated.
10.0 PACKAGING
v Strict observation of the SOP during the intimate packing will not permit any cross contamination.
11.0 PRECAUTION
v The above is only illustrative and is only through understanding and committed observance of prescribed procedures that we can produce without contamination.

Wednesday, May 20, 2009

Hazardos Material Handling & Storage Precautionary Measures

Sampling of hazardous materials should be done in the quarantine area incoming with the safely standards, using masks, gloves and respirators by Q.C. personal. The samples should be properly secured in containers and labeled to indicate the relevant details.
Testing of these chemicals must be performed by trained analyst who is aware of GLP and safety aspects. The status labels e.g. approved / rejected should be pasted as soon as the testing is completed and the material is then removed from the quarantine to the proper storage area.
The solvents should be handled / used very carefully during production operations. The operators must be trained for handling the material and must wear all necessary protective gadgets during processing. The departmental head would be responsible for their proper handling and use.
Transportation of hazardous material / solvents should only be made in closed containers which if palletized must be security placed to avoid spillage and accident.
The solvent store should have a quarantine area, a rejected material area and a dispensing area. The drums / containers should be properly arranged and container to container bonding should be made to avoid static charge to develop.The general handling procedure of hazardous material depends upon the following and the production, warehouse and Q.C.D. personal should be aware of it

Hazardos Material Handling & Storage Procedure

Sampling of hazardous materials should be done in the quarantine area incoming with the safely standards, using masks, gloves and respirators by Q.C. personal. The samples should be properly secured in containers and labeled to indicate the relevant details.
Testing of these chemicals must be performed by trained analyst who is aware of GLP and safety aspects. The status labels e.g. approved / rejected should be pasted as soon as the testing is completed and the material is then removed from the quarantine to the proper storage area.
The solvents should be handled / used very carefully during production operations. The operators must be trained for handling the material and must wear all necessary protective gadgets during processing. The departmental head would be responsible for their proper handling and use.
Transportation of hazardous material / solvents should only be made in closed containers which if palletized must be security placed to avoid spillage and accident.
The solvent store should have a quarantine area, a rejected material area and a dispensing area. The drums / containers should be properly arranged and container to container bonding should be made to avoid static charge to develop.
The general handling procedure of hazardous material depends upon the following and the production, warehouse and Q.C.D. personal should be aware of it.
Nature of hazard which can be chemical resulting into toxic, irritant, corrosive flammable or non flammable effects.
Severity of effect can either be high, low or mild.
Effect on human body – ingestion, inhalation or the contact with skin and eyes affects badly to human beings. There could be two risks such as fire and health while handling the hazardous material.
Fire / explosion of outcome of fire due to spark, flame or heat. To control the fire risk removal of flame or ignition source e.g. electronic spark, electrostatic charge or short circuiting must be looked into.
Provision of fire fighting equipment as the emergency response system.
If a substance is declared hazardous it is important to find out what health risk is expected from it, the usual risks are:
Eye – avoid making contact with eyes, wear goggles and in case of contact wash with plenty of water and seek medical help.
Skin – wear in previous clothing / glove. In case of contact wash thoroughly and change contaminated clothing for washing.
Inhalation – use proper masks during handling, if inhaled remove the victim from the site to fresh air and ask for medical help.
Ingestion – for safety purpose it is advised not to eat / drink near the chemicals while handling.
There should be NO SMOKING around the area and NO SMOKING signs should be appropriately displayed.
Keep the area cool and ventilated and store the material away from direct sunlight and heat.
Keep the containers tightly closed.
While handling the material it has to be taken into account whether the material is on laboratory or production scale in their case it must be handled by:
Wearing proper impervious clothing.
Wearing gloves suitable for chemical resistance and antistatic.
Wearing goggles and face masks where necessary.
Removing all source of ignition so that there is no danger of fire.
Using masks with filters is dust of fume generation. If the dust or fumes are harmful use breathing apparatus and avoid breathing and avoid breathing directly.
Eating chewing and drinking should be avoid.
If there is any spillage during handling it should be immediately cleaned and wiped off. It is advisable to wash the area with plenty of water, mopped to dry and ventilated for fresh air.
Some solvents have chemical affinity with other substances and when combined produce hazardous situation. In such cases the chemical compatibility with other chemical should be known and these must be stored separately.
Proper labeling of the solvents is extremely necessary to indicate their properties, health and fire hazards and important for recognized and evaluating the hazards, the label must contain the following.
Product Name
Chemical Name
Chemical Formula
Manufacturer’s Name
Supplier’s Name
Physical Properties
Boiling point _________ Flash point __________ Fire point_________
Explosion limit
Susceptibility to heating
Product formed in case of fire
Suitable fire extinguisher
Handling Precaution
Transport Precaution
Storage Precaution
Chemical Properties
First Aid recommendations in case of
Eye’s Contact
Skin Contact
Inhalation
Ingestion
Recommended safely wears
The general methods of controlling environmental factors which may cause sickness or significant discomfort to the staff include the following.
Change or alteration of a process or work operation to reduce the number of persons exposed.
Adoption of methods to reduce fumes or dust generations during production operation material handling.
Isolation or enclosure of a process to reduce the number of persons exposed.
Local exhaust facility to be provided at the dispensing stage or dust generation point.
Efficient ventilation system to be provided for safe atmosphere.
Use of protective devices / clothing to be emphasized.
Adequate waste disposal and good house keeping to be exercised.
Substitution of less harmful chemical for processing to be looked.
Control into methods and their follow up to be exercised.
Training and education of personnel involved in handling of the hazardous material plays an important part in controlling the environment factors and to avoid the health and fire risks.
A periodic medical checkup of the staff is also important who are involved in handling the hazardous material.

Hazardos Material Handling & Storage

1 – Purpose
§ The purpose of issuing this procedure is to ensure that hazardous solvents and chemicals are stored in accordance with the acceptable rules and regulations. As well as to maintain a safe working environment, so that there are no hazards to employees and building / property. This depends on understanding the properties / behavior of chemicals and they are properly handled.
The ordering, storage, issuance and use of all hazardous materials should be in accordance with the corporate safety standards and as per government regulations.
2 - It is applicable in production departments, Raw Material Store.
3 – Responsibility
Q.C. Manager
Production Manager
Store Incharge

Sunday, May 10, 2009

Cleaning of Dispensing Equipment

Principle
Pharmaceutical products can be contaminated by other pharmaceutical products, by cleaning agents, by micro-organisms or by other materials (e.g. dust, lubricants, raw materials, intermediates etc.) in many cases the same equipment may be used for processing different products. To avoid contamination, adequate cleaning procedures are essential.
Procedure
For every drug substance dedicated equipment (scoop, spatulas etc.) are used.
Dispensing equipment used for excepients is not dedicated; however, cleaning procedure for all the equipment is same.
Immediately after completing the dispensing operation, the dispensing equipment is carefully wrapped in a polythene bag and placed in a plastic box that has been labeled, used scoops / spatulas for cleaning.
After completing the dispensing operation, the dispensing equipment contained in the box is removed from dispensing area for cleaning. The operator should wear rubber gloves before commencing cleaning.
Equipment is scrubbed with 2% teepol solution and rinsed under running tap. To remove sticky substances, the equipment are rinsed with hot water and scrubbed with 2% teepol solution. After rinsing under running tap water, the equipment is rinsed with distilled water and allowed to drain. Then the equipment is sprayed with 70% Isopropyl Alcohol and dried.
The cleaned and dried equipment is wrapped in aluminum foil and covered with Kraft paper. A label “I AM CLEAN” is affixed.
The ready to use equipment is stored in a closed box for future use.

Friday, May 8, 2009

Raw Material Issuance

1.Purpose
This standard operating procedure outlines the method for the dispensing and issuance of approved raw material requested for processing by the production department on relevant manufacturing orders.

2.Responsibility
Store Incharge
Store Officer
Production Officer
Quality Control Officer
3.Procedure
Before commencing the dispensing, check that:
Dispensing area is clean.
Dispensing table is clean.
No raw materials of the previous weighing are lying in the dispensing area.
The weighing balance is clean and calibrated. (The calibration should be properly recorded on the weighing balance calibration sheet attached to the balance).
The weighing accessories i.e. scoops spatulas are properly cleaned.
The protective garments i.e. gloves and face masks are available and the personnel engaged in dispensing and checking is wearing them.
The rubber gloves are provided for the dispensing of potent drugs.
The required relative humidity is present and a daily record is being maintained.
Only one raw material is brought at one time for dispensing.
The spillages are removed at once and the exhaust system is properly working.

The bin cards should be properly maintained for all raw materials and FIFO policy should not be disturbed at any time.
The dispensing should be done by the warehouse officer or his designate for proper and accurate a cross check system of the weighing / dispensed materials is made and recorded.
The dispensing should only be done after thorough checking of the manufacturing order for the Product’s name, Code No., M.O. No., Batch Size and Date.
The dispensing of any raw material should not be made prior to checking the condition of container; the Q.C. released label and revalidation date as well as the properly maintained ware house label or tag. Every container must be released like original after dispensing.
The raw materials must be weighing very carefully on a balance of appropriate accuracy in appropriate containers after checking their tare weights.
Each raw material must be checked for its physical appearance order and presence of any foreign substance or particles. If the appearance is doubtful or it contains extraneous material or particles it should not be issued for processing but should be immediately quarantined and referred to the Quality Control Department for re-checking.
The raw material must be issued against the Lot No. or A. No. any material of two different lots should be weighing separately and issued in separate should area be recorded on the manufacturing order.
After completing the dispensing of every individual item the issued Qty. a Lot No., weighing by and checked by columns of the manufactured order must be properly initialed.
All raw materials issued against any manufacturing order must be kept separately in an area un-accessible to the unauthorized personal or under lock and key.

Raw Material Issuance

Thursday, May 7, 2009

Storage and Handling of Packing Material

1 – Scope
This procedure is applicable for storage and handling of all kind of Raw / Packing Materials in Warehouse.


2 – Procedure

Suitable Machinery / Equipments
Lifter
Loaders

Storage of Packing Materials

Q.C. Inspector will check that Packing Material is placed on the neat and clean iron pallets or in wracks.
No container, drum, bag containing the Packing Material(s) is stored directly on the floor or in contact with the walls and ceiling.
Inflammable raw materials are kept separately in controlled area.
Separate area has been developed and maintained for moisture and temperature sensitive material equipped with hydrometers and dehumidifiers and maintain the moisture level below 65% and temperature below 30°C in the area for moisture and temperature sensitive materials.
All the bags, drums, containers having materials had identification slips issued by the Quality Control Department.
Glass materials, Aluminum foil, PVC / PVDC silica bags, caps closures etc. are stored separately from unit cartons and labels.
Outer cartons will be stored separately.
Glass Bottles in outer cartons are stacked on pallets in storage area at the maximum height of 13 feet.
The material(s) kept in the relevant areas i.e.
Released Materials in bulk store.
Quarantined / Sampled Materials in Quarantine Area.
Quarantined Area must have yellow boundaries while non-conforming area red boundaries.
Remove the quarantined slip while in released, non-conforming and rejected status.
Do not store the material on the floor or in contact with walls or ceilings.

Tuesday, May 5, 2009

Storage & Handling of Raw Material

1 – Scope
This procedure is applicable for storage and handling of all kind of Raw Materials in Warehouse.
2 – Responsibility
Store Incharge
Production Manager
Store Supervisor
Store Helpers
3 – Procedure
Suitable Machinery / Equipments

Lifter
S.S. Scoop
Dehumidifier
Loaders
Thermometer
Metallic Spatula

Storage of Raw Materials

Q.C. Inspector will check that Raw Material is placed on the neat and clean iron pallets or in wracks.
No container, drum, bag containing the Raw Material(s) is stored directly on the floor or in contact with the walls and ceiling.
Inflammable raw materials are kept separately in controlled area.
Separate area has been developed and maintained for moisture and temperature sensitive material equipped with hydrometers and dehumidifiers and maintain the moisture level below 65% and temperature below 30°C in the area for moisture and temperature sensitive materials.
All the bags, drums, containers having materials had identification slips issued by the Quality Control Department.
The material(s) kept in the relevant areas i.e.
Non-Conforming Materials in separate area.
Quarantined / Sampled Materials in Quarantine Area.
Quarantined Area must have yellow boundaries while non-conforming area red boundaries.
Do not store leaked, torn or dirty container, bag, drum etc. until it is cleaned.

Handling of Raw Materials

Neat and clean coat, cap, gloves and mask are being used where necessary.
Separate cleaned and dried metallic scoop being used for handling of solid in bulk quantities.
Metallic spatula, spoon are used to handle small quantities of solids.
Bulk quantities of liquids are being handled through the buckets, small container etc.
Small quantities of liquids are handled with pipettes, beakers, measuring cylinder etc.
Glass / Plastic cylinders will be used to take out liquids.
In case of any loss of material due to mishandling or accident, inform Senior Warehouse Officer for necessary action.
Drum, containers, bags etc. containing materials are handled using loaders and lifters and trolleys.
Scoop pipettes, beakers, measuring cylinders etc. shall never be kept on the floor.