Purpose:
It is established for washing of equipments used in the store.
2. SCOPE:
It is applicable to Ware house.
3. RESPONSIBILITIES:
1. Manager Stores
2. Assistant Manager Stores
3. Supervisor
4. PROCEDURE:
1. Wash the scoop/bucket with warm water.
2. Put the soap / detergent on it and rub with a clean cloth.
3. Rinse thoroughly to remove the detergent completely.
4. Dry with a clean cloth.
5. Soak a clean cloth with IPA and rub it once on the scoop/bucket & let it dry.
6. Put the washed tools in polythene bags and keep in the specified place.
Wednesday, May 12, 2010
STANDARD OPERATING PROCEDURE Title: VIAL WASHING
1. Purpose
It is established to provide a standard procedure for “Vial Washing”.
1 Scope
It is applicable to injection section.
2 Responsibilities
1. Production Pharmacist
2. Supervisor
3. Worker
3 Procedure
Vial washing is done in two steps
1. Pre-washing
2. Final washing
1. Pre- Washing
a) Wear the mask and cover the hair properly with cap.
b) Stack the vial cartons received from store on the clean pallet in de-cartoning area.
c) Wash thoroughly the sinks of washing station and drain out any dirty water.
d) Fill the sinks of washing stations up to half with tap water.
e) In sink-1,add one bottle of liquid hands to make lather.
f) Pick up one carton of vial from de-cartoning area, remove its secondary packing, and dip the vials in the sink. Discard primary packing in the dust bin kept for this purpose in de-cartoning area.
g) Add to the 2-3 vials cartons similarly.
h) Brush each of the vial in sink with nylon material from in and outside.
i) Transfer each of the brushed vial in sink-2.
j) In sink-2 give the vial individually a rinse of tap water by filling the vials with water in the sink and emptying in the same sink.
k) Rinse each of the vial two times in this way and drop into the sink -3.
l) In sink-3, process of rinsing is repeated and the vials are arranged in the washed SS trays.
m) In the trays vials are placed with their neck downward These vials rare ready for final washing
n) Cycle of washing from Sink-1 to Sink-3 is repeated for whole of batch.
o) Water in each of the three sinks is changed with fresh one after it gets dirty.
2. Final washing
a) Give the pre-washed a final washing on the “ vial washing machine” following the Standard Operating Procedure for “Vial Washing Machine(GL/SOP/M/078)”
It is established to provide a standard procedure for “Vial Washing”.
1 Scope
It is applicable to injection section.
2 Responsibilities
1. Production Pharmacist
2. Supervisor
3. Worker
3 Procedure
Vial washing is done in two steps
1. Pre-washing
2. Final washing
1. Pre- Washing
a) Wear the mask and cover the hair properly with cap.
b) Stack the vial cartons received from store on the clean pallet in de-cartoning area.
c) Wash thoroughly the sinks of washing station and drain out any dirty water.
d) Fill the sinks of washing stations up to half with tap water.
e) In sink-1,add one bottle of liquid hands to make lather.
f) Pick up one carton of vial from de-cartoning area, remove its secondary packing, and dip the vials in the sink. Discard primary packing in the dust bin kept for this purpose in de-cartoning area.
g) Add to the 2-3 vials cartons similarly.
h) Brush each of the vial in sink with nylon material from in and outside.
i) Transfer each of the brushed vial in sink-2.
j) In sink-2 give the vial individually a rinse of tap water by filling the vials with water in the sink and emptying in the same sink.
k) Rinse each of the vial two times in this way and drop into the sink -3.
l) In sink-3, process of rinsing is repeated and the vials are arranged in the washed SS trays.
m) In the trays vials are placed with their neck downward These vials rare ready for final washing
n) Cycle of washing from Sink-1 to Sink-3 is repeated for whole of batch.
o) Water in each of the three sinks is changed with fresh one after it gets dirty.
2. Final washing
a) Give the pre-washed a final washing on the “ vial washing machine” following the Standard Operating Procedure for “Vial Washing Machine(GL/SOP/M/078)”
Standard Operating Procedure Title: VALIDATION OF STEAM STERILIZATION
Purpose:
• It is established for the proper validation of the sterilization process.
2. Scope:
• It is applicable to microbiological Lab.
3. Responsibilities:
• GM Production
• Quality Control Manager
• Microbiologist.
4. Procedure:
• Biological indicators to be used:
Strain of bacillus stearothermophillus ATCC 7953
• Take 3-4 ampoules of above mentioned biological indicator in container in which the other filled ampoules are placed which are to be sterilized in autoclave.these ampoules of biological indicators are placed at different places of autoclave so that to check the proper sterilization process.Close the access door and continue to operate the apparatus.
• After completion of the sterilization procedure, and at a noted time with in 2 hours, aseptically add each contents of ampoule in 30 ml of Soybean Casein Digest Medium.Incubate each media at a temperature of 55-60oC. Observe each inoculated medium at 24 hours and 48 hours,and every 1 or 2 days thereafter for a total of 7 days. If after 7 days of incubation there is no growth in the medium the test for sterilization is met.
Quality Record(s)/Form(s)
The following quality records shall be generated in accordance with the procedure for Control of Company Quality Records (4.12).
Required Record Form No.
Destruction Note QF/115/01
• It is established for the proper validation of the sterilization process.
2. Scope:
• It is applicable to microbiological Lab.
3. Responsibilities:
• GM Production
• Quality Control Manager
• Microbiologist.
4. Procedure:
• Biological indicators to be used:
Strain of bacillus stearothermophillus ATCC 7953
• Take 3-4 ampoules of above mentioned biological indicator in container in which the other filled ampoules are placed which are to be sterilized in autoclave.these ampoules of biological indicators are placed at different places of autoclave so that to check the proper sterilization process.Close the access door and continue to operate the apparatus.
• After completion of the sterilization procedure, and at a noted time with in 2 hours, aseptically add each contents of ampoule in 30 ml of Soybean Casein Digest Medium.Incubate each media at a temperature of 55-60oC. Observe each inoculated medium at 24 hours and 48 hours,and every 1 or 2 days thereafter for a total of 7 days. If after 7 days of incubation there is no growth in the medium the test for sterilization is met.
Quality Record(s)/Form(s)
The following quality records shall be generated in accordance with the procedure for Control of Company Quality Records (4.12).
Required Record Form No.
Destruction Note QF/115/01
Standard Operating Procedure Title: VALIDATION OF ANALYTICAL METHOD
1.0 Purpose
1.1 It is established to assure quality in all aspects, and to avoid any unintentional contravention of Drug Act, cGMP and company standards.
2.0 Scope
2.1 It is applicable to all types of incoming and out going materials and all type of activities / process, conditions, equipment, documents, material and any “thing” (i.e. conditions, process, activity, material, equipment and document) which can affect quality directly or indirectly.
3.0 Responsibilities
3.1 Manager Quality Assurances.
3.2 Assistant Manager Quality Assurance.
3.3 Quality Assurance Officer.
4.0 Procedure
4.1. During the routine in process checks if any thing found to be in contravention of any requirements, regulations, system (which are well defined in SOPs, SMPs, and Product Specification) matter will be discussed with relative incharge / Departmental Head to remove that short coming.
4.2. If the production department takes no action on verbal intimation that particular thing will be “HOLD” by affixing red specified label of “HOLD” which means to stop that “thing” (already defined).as and where it is.
7. Precision: Reference Standard deviation calculation by 5 injection / reading of the same dilution should not be greater than 1%.
8. Accuracy of the Method: Different concentrations of active ingredient are mixed with the auxiliaries. The results should not differ by + 2 %.
9. Results are recorded by the Analyst in ledger and data is reviewed by the QC Manager.
1.1 It is established to assure quality in all aspects, and to avoid any unintentional contravention of Drug Act, cGMP and company standards.
2.0 Scope
2.1 It is applicable to all types of incoming and out going materials and all type of activities / process, conditions, equipment, documents, material and any “thing” (i.e. conditions, process, activity, material, equipment and document) which can affect quality directly or indirectly.
3.0 Responsibilities
3.1 Manager Quality Assurances.
3.2 Assistant Manager Quality Assurance.
3.3 Quality Assurance Officer.
4.0 Procedure
4.1. During the routine in process checks if any thing found to be in contravention of any requirements, regulations, system (which are well defined in SOPs, SMPs, and Product Specification) matter will be discussed with relative incharge / Departmental Head to remove that short coming.
4.2. If the production department takes no action on verbal intimation that particular thing will be “HOLD” by affixing red specified label of “HOLD” which means to stop that “thing” (already defined).as and where it is.
7. Precision: Reference Standard deviation calculation by 5 injection / reading of the same dilution should not be greater than 1%.
8. Accuracy of the Method: Different concentrations of active ingredient are mixed with the auxiliaries. The results should not differ by + 2 %.
9. Results are recorded by the Analyst in ledger and data is reviewed by the QC Manager.
STANDARD OPERATING PROCEDURE Title: WEIGHING BALANCE
PURPOSE:
It is established to provide guidelines for use of weighing balance.
2. SCOPE:
It is applicable to Ware house.
3. RESPONSIBILITIES:
1. Manager Stores
2. Assistant Manager Stores
3. Supervisor
4. PROCEDURE:
1. Switch on the balance.
2. Check that the reading is zero.
3. Put the empty bag container on the pan of the balance.
4. Press “Tare”.
5. Put the material in bag/container.
6. Carefully take the reading.
7. Remove the material from balance and press “zero” to adjust the balance reading at zero.
5. CAUTION:
1. Use only specified adapter.
2. Never put the material on balance with jerk.
It is established to provide guidelines for use of weighing balance.
2. SCOPE:
It is applicable to Ware house.
3. RESPONSIBILITIES:
1. Manager Stores
2. Assistant Manager Stores
3. Supervisor
4. PROCEDURE:
1. Switch on the balance.
2. Check that the reading is zero.
3. Put the empty bag container on the pan of the balance.
4. Press “Tare”.
5. Put the material in bag/container.
6. Carefully take the reading.
7. Remove the material from balance and press “zero” to adjust the balance reading at zero.
5. CAUTION:
1. Use only specified adapter.
2. Never put the material on balance with jerk.
STANDARD OPERATING PROCEDURE Title: Temperature/Humidity Daily/Weekly Record
1. PURPOSE
• It is established Humidity & Temperature.
2. SCOPE
• It is applicable to Q.A Department.
3. RESPONSIBILITY
Procedure:
• Readout the dry bulb reading of hygrometer.
• Also readout the wet bulb reading of hygrometer.
• Subtract the wet bulb temperature from dry bulb temperature and note the humidity by taking the difference in humidity chart in contrast with dry bulb reading.
LIMITS:
Section HUMIDITY TEMPERATURE
Dry Injection NMT 40% 30 oC
Controlled Room NMT 50% 25 oC
Capsules NMT 45% 30 oC
Dry Suspension NMT 45% 30 oC
Tablet
(In case of Ranitidien) NMT 50 %
NMT 40% 30 oC
30 oC
Powder NMT 36% 35 oC
4. QUALITY RECORD(s)/FORM(s)
The following Quality Records shall be generated and managed in accordance with the procedure for Control of Company Quality Records (4.12).
Required Record Form Reference No.
Temperature /Humidity
Daily /Weekly Record QF/005/01
• It is established Humidity & Temperature.
2. SCOPE
• It is applicable to Q.A Department.
3. RESPONSIBILITY
Procedure:
• Readout the dry bulb reading of hygrometer.
• Also readout the wet bulb reading of hygrometer.
• Subtract the wet bulb temperature from dry bulb temperature and note the humidity by taking the difference in humidity chart in contrast with dry bulb reading.
LIMITS:
Section HUMIDITY TEMPERATURE
Dry Injection NMT 40% 30 oC
Controlled Room NMT 50% 25 oC
Capsules NMT 45% 30 oC
Dry Suspension NMT 45% 30 oC
Tablet
(In case of Ranitidien) NMT 50 %
NMT 40% 30 oC
30 oC
Powder NMT 36% 35 oC
4. QUALITY RECORD(s)/FORM(s)
The following Quality Records shall be generated and managed in accordance with the procedure for Control of Company Quality Records (4.12).
Required Record Form Reference No.
Temperature /Humidity
Daily /Weekly Record QF/005/01
STANDARD OPERATING PROCEDURE Title: Procedure for Sterility Testing
1. Purpose
It is established to provide a standard procedure for “Sterility testing”.
2. Scope
It is applicable sterile products and raw materials.
3. Responsibilities
QC Manager
Microbiologist
4. Procedure
The following procedures are applicable for determining whether test sample complies with the pharmacopoeial test for sterility or not.
1. Membrane filtration method
2. Direct transfer method
Membrane filtration method:
• A suitable membrane filtration unit consists of an assembly, which makes easy, the aseptic handling of the test sample and allows the transfer of processed membrane to the sterile media, for incubation.
• A membrane suitable for sterility has a rating of 0.45ยต and a diameter of 47mm approx.
• The membrane should wet prior to testing with D/water.
• The filtration unit and membrane must be sterilized and store to maintain the performance characteristic.
• Dissolve the material to be tested in the sterilized peptone buffer.
• Shake to dissolve.
• Pass through membrane filter unit.
• Divide the processed membrane into parts.
• One part is put into FTM and other into SDB media.
• Place the FTM in an incubator at temperature of 30o –35oC, while SDB media is incubated at 20o - 25oC for 14 days.
5. Interpretation of test results:
• When no microbial growth is observed the article passes the sterility test.
• When microbial growth is observed, and then repeats the process. If no growth is observed this time, the test sample passes the sterility test.
If the growth of the same physical appearance is observed, then repeat the test with double volume or weight of test sample.
• If the test sample is free from microbial growth this time, then material passes the test. But in case of growth of same physical appearance, the test sample is rejected.
6. Safety precautions:
1. For cleaning of sterile area before Sterility testing, follow SOP “Cleaning procedure for sterility room” GL/SOP/QC/030
2. For personnel safety measure, follow the instruction for entering in Sterility room, GL/SOP/QC/029
It is established to provide a standard procedure for “Sterility testing”.
2. Scope
It is applicable sterile products and raw materials.
3. Responsibilities
QC Manager
Microbiologist
4. Procedure
The following procedures are applicable for determining whether test sample complies with the pharmacopoeial test for sterility or not.
1. Membrane filtration method
2. Direct transfer method
Membrane filtration method:
• A suitable membrane filtration unit consists of an assembly, which makes easy, the aseptic handling of the test sample and allows the transfer of processed membrane to the sterile media, for incubation.
• A membrane suitable for sterility has a rating of 0.45ยต and a diameter of 47mm approx.
• The membrane should wet prior to testing with D/water.
• The filtration unit and membrane must be sterilized and store to maintain the performance characteristic.
• Dissolve the material to be tested in the sterilized peptone buffer.
• Shake to dissolve.
• Pass through membrane filter unit.
• Divide the processed membrane into parts.
• One part is put into FTM and other into SDB media.
• Place the FTM in an incubator at temperature of 30o –35oC, while SDB media is incubated at 20o - 25oC for 14 days.
5. Interpretation of test results:
• When no microbial growth is observed the article passes the sterility test.
• When microbial growth is observed, and then repeats the process. If no growth is observed this time, the test sample passes the sterility test.
If the growth of the same physical appearance is observed, then repeat the test with double volume or weight of test sample.
• If the test sample is free from microbial growth this time, then material passes the test. But in case of growth of same physical appearance, the test sample is rejected.
6. Safety precautions:
1. For cleaning of sterile area before Sterility testing, follow SOP “Cleaning procedure for sterility room” GL/SOP/QC/030
2. For personnel safety measure, follow the instruction for entering in Sterility room, GL/SOP/QC/029
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