Traning Report
Traning Report
Traning Report
PREFACE
This training report highlights the techniques and procedures studied and performed in
the QA/QC department of Lupin Ltd.Mandideep.the student of VNS Institute of
Pharmacy.(Affiliated to Rajiv Gandhi Prodyogiki Vishwavidhalaya) undergoes a one
month traing programme to enhance his skill and knowledge. Thus it helps to understand
the industrial application of various theoretical aspects of Pharmacy.
Lupin product reach more than 50 countries with significant presence in besides
India,Russia,US,Kazhakistan and China.
The lupin plant at Mandideep manufactures both APIs and finished dosages.
SOFTOVAC
FIBRIL
SOFTOVAC SF
FIBRIL SF
AKNOWLEDGEMENT
i wish to express my sincere thanks to those who helped me to develop this project report.
at first i extend my thanks to Mr.C.A.Nair (personel and administration manager) for giving me
this oppourtunity to complete my industrial training in LUPIN LTD.
i express my sincere indebtness and profound sense of gratitute to my project guide Mr.Johnson
MJ for their untiring labour and generous efforts which enabled me layout the work of this project.
i am also thankful to Mr.Ajit Jaiswal and Mr.Praveen Kumar Sahu for their valuable suggestion,
constant encouragement, overwhelming help and cooperation.
This project would never have taken this shape without the parenteral care watchful help of Mr.Jai
Devan and other staff members of LUPIN LTD.
with immerse pride and deep gratitute for which i am left with no word.
Finally, i have no reservation in admitting that it was nothing else but the grace of God that
enabled me to achieve this seemingly invisible task.
CONTENTS
1. INDUSTRIAL PROFILE
2. QUALITY POLICY OF LUPIN
3. QUALITY ASSURANCE
4. QUALITY CONTROL
5. ABOUT THE PRODUCTS
6. INSTRUMENTS USED IN QA/QC LAB
7. PRODUCTION DEPARTMENT
8. INTRUMENTS USED IN FORMULATION
9. GENERAL TESTS OF SOFTOVAC
10. LIMIT TESTS PROCEDURE FOR ANALYSIS OF SOFTOVAC
11. MANUFACTURING OF SOFTOVAC
12. CONCLUSION
INTRODUCTION
Lupin and its pharma and R$D facility,generic research of API,new chemical
entities,research facilities at Pune,Lupin Ltd. Mandideep has pharmaceutical formulation
and bulk plants located at 198-202,New Industrial Area no.2,
Mandideep,distt:Raisen(M.P.)
The company has about 3000 employees on its roll for all the sites put together. the total
area is allocated for the following functions-
-manufacturing
-quality assurance
-warehouse
-utilities
-administration and canteen
QUALITY ASSURANCE
The quality assurance department (QED) has the responsibility and authority to define
norms and regulations for various activities including personel training,sanitization and
cleaning of general areas. Quality assurance department rewiews the production records
to ensure that all manufacturing operations are carried out as per the laid down
instruction.
• All production facilities are provided to meet cGMP requirements and adequately
trained and quality person for carrying out the operation.
• All manufacturing operations are clearly designed and checked routinely to
confirm the quality of finished products.
After the completion of labelling and packing operation, finished goods are transferred to
inhouse quarantine area, on completion of testing and final inspection of finished
goods,the batch records are sent to quality assurance for rewiew. On satisfactory
compliance the quality assurance/ quality control department shall issue release note for
further distribution.
QUALITY CONTROL
the quality control department is part of quality assurance department.it is the department of
pharmaceutical industry which deals with the control of quality of raw materials are manufactured
product. the major activities of Quality control department are:-
It is responsible for approving or rejecting the raw materials,packing materials and finished
manufactured,process,packed or label by the company.
the company follows ths specifications and test methods as per IP/BP/USP for raw materials and
finished products.the company has also additional in-house laid down specifications for testing of
finished products and raw materials,which are stringent than the pharmacopoeial limits for better
control on quality of products.
• Intrumental analysis
• Microbiological section
• Documentation section
INSTRUMENTATION ANALYSIS
MICROBIOLOGICAL SECTION
It is second part of QC,it detects the biological load present in the drug.
DOCUMENTATION SECTION
it is the main department of QC where all records,files and reports are stored and maintained by a
responsible person.this department perforns following functions_
it deals with quality control of various packaging materials.it checks the following parameters_
-batch no
-printing quality
-thickness of aluminium foil
-width of material
-size of label
-adhesive quality
-colour scheme.
Testing in QC
Approved
Packaging department
PRODUCTS
1. SOFTOVAC
2. SOFTOVAC SF
3. FIBRIL
4. FIBRIL SF
PRODUCTION DEPARTMENT
INGREDIENTS
SOFTOVAC
liquorice (mulethi)
rose petals (gulab dal)
fennel seeds (saunf)
sugar (sharkara)
sodium benzoate
DOSAGE
adult : 5-10 gm
children : 2.5-5.0 gm
MECHANISM OF ACTION
ISABGULA
mechanism of action :- it contains natural colloidal mucilage which forms a gelatinus mass by
absorbing water, thus softening and facilitating colonic transit of stool.
dosage :- adults : 5-10 gm of husk mixed with water or milk at bed time.
children :not recommended
status in :-
pregnancy : contraindicated
lactation : use with caution
old age : use with caution
children : not recommended
Description/appearance
Procedure
1. Visually check the product liquid or solid dosage forms with unaided eyes.
2. Check the following whether the material is liquid or solid.
3. Colour of material.
4. Odour/Odourless
Loss on drying (LOD):- Loss on drying is the loss in weight in %w/w resulting from
water and volatile matter of any kind can bedriven of under specified conditions.
Apparatus:-
Procedure-
Apparatus:-
1. silica or platinum crucible.
2. muffle furnace.
3. calibrated balance.
4. desicators.
Procedure-
Residue on ignition;
(%w/w)=B/A*100
where,
A is wt. of the residue in gm.
B is wt. of the sample in gm.
TOTAL ASH
Apparatus-
1. Silica/Platinum crucible
2. A calibrated balance.
3. A dessicator.
Procedure-
1. Weigh 1g of the sample in a previously weighed crucible.
2. Place the crucible in a muffle furnace maintained at 600+ or -25c for at least 2hrs.
4. Cool the crucible to room temperature in a dessicator and weigh it.
5. Calculate the weight of residue left out in the crucible.
Acid insoluble ash determines the organic impurities present in the substance by
incinerating the substance at 600= or -25c.
Apparatus-
1. Silica/Platinum crucible.
2. A calibrated balance.
3. A dessicator.
Procedure-
1. Boil the ash obtained in the test for total ash with 25ml of 2 molar HCl for 5min
and filter on the filter paper.
2. Wash with hot water and ignite the filter paper in the crucible at 600+ or -25c till
all residues becomes white.
3. Cool the crucible and weigh it.
4. Caklculate the % of acid insoluble ash with help of weight of residue left out in
the crucible.
pH
The pH value conventionally represents the acidity or alkalinity of an aqueous solution.
It is also defined as the negative logarithm of the hydrogen ion conc.of solution.
pH= -log(H)
Procedure-
1. Use calibrated pH meter to measure the pH of aqueous solution.
2. Wash the electrode and temperature sensor with distilled water.
3. Remove the excess of water with the help of a filter paper.
4. Immense the pH electrode and temperature sensor in the test solution and read its
pH value at 25 + 2c.
5. After measurement wash the electrode 2-3 times with the distilled water.
Procedure-
1. Weigh 1gm of sample in a 100ml graduated measuring cylinder and add 10ml
distilled water.
2. Shake gently for 1min and make up the volume upto 90ml with water.
3. Make up the volume to 100ml with water again shake gently with glass rod
approximate for 1min.
4. Allow it to stand for 3hrs.
5. Measure the volume of mucilage.
6. Carry out the test in triplicate and the average of 3 samples determine the swell
power of isapgol mucilage.
Bulk density of a powder is the value if the density in gm/ml as per powered or as
passively filled into a measuring vessel. Bulk density may also be defined as the ratio
of the sample weight taken and the sample volume occupied before tapping. The
tapped density is a limiting attained after tapping down. Usually in a device that lifts
and drops a volumetric measuring cylinder containing the powder a fixed distance.
Apparatus-
1. A calibrated balance.
2. Bulk density apparatus.
3. Dry 50ml graduated cylinder with stopper.
Procedure-
1. Fill the stopper dry granulated cylinder with sample under examination upto 50ml
mark.
2. Note the wt. of the sample and calculate the bulk density by the formula.
This test describes the procedure of determining water soluble extracts in sample or
material.
Apparatus-
1. Calibrated balance.
2. Pteridish / flat bottomed shallow dish.
3. Desscaiir with silica gel.
4. Water bath.
5. Electric oven.
Procedure-
1. Weight 1gm of powder in a 250ml stopper flask.
2. Add 100ml distilled water and keep for 24hrs shaking frequently during the first
6hrs and allow to stand for next 18hrs.
3. Filter and pipette out 25ml of the filterate in a pteridish.
4. Evaporate the filterate on water bath and then dry the dish at 105c.
5. Cool the dish in a dessicator.
6. Calculate the % of water soluble extract with the help of the residue left in the
pteridish after evaporation of filterate.
ASSAY
(a) Tannins (sample prepration)-
1. Weigh accurately 0.4gm of softovac powder in a 100ml volumetric flask.
2. Make up the vol. with water and stir for 15min and decant the supernatant.
Procedure-
1. Pipette out 50ml of the above solution in a 1000ml beaker and add 700ml of
distilled water.
2. Add 25ml of indigo sulphuric acid solution, stir the content with the help of a
magnetic stirrer.
3. Titrate with 0.01N potassium permagnet sol. Till a golden yellow end point
appears.
4. Each ml of 0.01N potassium permagnet sol. Is equipment to 0.0004157g of
tannins.
5. Run a blank test by titrating 25ml of indigo sulphuric acid in 750ml of water in a
1000ml beaker.
Procedure-
1. Weight accurately 0.4gm of sample in a 100ml of volumetric flask.
2. Add 20ml of ferric chloride solution.
3. Add 0.1-0.5gm of sodium bicarbonate and 10ml of distilled water.
4. Shake gently and heat by dipping in a water bath for 20min.
5. Add 1.5ml of conc. HCl, shake well and heat again on water bath for further
20min till the precipitate or solution becomes clear.
6. Take out the the flask and cool.
7. Transfer the contents into a separating funnel and extract with 40ml of diethyl
ether.
8. Collect ether layer in the 100ml of volumetric flask and make up the volume with
ether.
9. Again extract twice with 25ml of diethyl ether.
10. Pipette out 25ml from it and transfer in the 100ml beaker and evaporate it on a
water bath at 50c to dryness.
11. Dissolve the residue in 25ml of magnesium acetate solution.
12. Pink colour is produced, shake well till the residue dissolves completely.
13. Filter and take the absorbance of the solution at 515nm.
RAW MATERIAL
SENT TO WAREHOSE
SIFTING
MILLING
MIXING
DRYING
FINAL BLENDING
TRANSFER TO IPC
PACK
CONCLUSION
I achieved a great deal of satisfaction and knowledge during my one month training at LUPIN
LTD. pharma industry.i gained a lot of insight into the industry by comparing the theoritical
aspects with practical aspects being followed. i got aquinted with industrial environment and with
industrial norms and practices being followed.
all my superiors and officers were very cooperative to lend the necessary support during my
traing period despite their hectic schedule.
i once again extend my heartfelt gratitute to each and every individual who directly or indirectly
helped me in completing my training successfully.