TRAINING REPORT BY

MISS. POOJA PANDURANG PAWAR

MISS. KOMAL VIJAY PINJARI

MRS. DINKAR RAJARAM CHAVAN

Student of D.Y PATIL AGRICULTURAL AND TECHNICAL

UNVERSITY , TALSANDE , KOLHAPUR

Dissertation Submitted to the

NAPROD LIFE SCIENCES

NAPROD LIFE SCIENCES PVT.LTD.
MIDC Tarapur, Boisar,
Dist.Palghar, Pin-401506

MR. PRAFUL BHOIR

(Sr. Manager, HR and Admin)

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ACKNOWLEDGEMENT
The internship opportunity I had with NAPROD LIFE SCIENCE Pvt.Ltd. was a
great chance for learning and professional development. Therefore I consider
ourselves as a very lucky as I was provided with an opportunity to be a part of it.
I also grateful for having a chance to meet so many wonderful people and
professionals who led us through this internship period.

By understanding during my internship period, I use this opportunity to express

my deepest gratitude and special thanks to MD of NAPROD LIFE SCIENCES,
Hon. Mr.Mohan B. Jain to carry out their esteemed Organization in Pharma
World.

We honestly express our gratitude to Hon.Dr. Vinayak Gaokar (AVP-Operations)

allowing us for industrial Training at “NAPROD LIFE SCIENCES”

We express my deepest thanks to Mr. Praful Bhoir (Sr. Mgr. HR and Admin),
Mr.Niteen Jadhav (Asst .Mgr. HR) for directing me towards every department
and their necessary advice and guidance.

We are thankful to Ms.Aruna Patil, training coordinator for guiding me while

preparing this report.

We express our extend my thanks to Mr. Kishor Patil (Sr.Mgr.Production) ,

Mr. Mahesh Saini (GM.Quality), Mr. Atul Rane (Mgr.WHD), Mr.
Sampatrao Patil (Mgr.QCD), Miss.Yotsna Mishra (sr.officer HR) , Mr.
Sambha Naik (Sr.Mgr.QCD), Mr. Balaji Ghuge (Mgr.QCM) Mrs. Rupal
Patil (Mgr.Packing), Mr. Samirali Sayyad (Sr.Mgr.Eng.HOD) NAPROD
LIFE SCIENCES.

By –
MISS. POOJA PANDURANG PAWAR

MISS. KOMAL VIJAY PINJARI

MRS. DINKAR RAJARAM CHAVAN

Student of D.Y PATIL AGRICULTURAL AND TECHNICAL

UNVERSITY , TALSANDE , DIST- KOLHAPUR

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CONTENT
INTRODUCTION:-
❖ QUALITY ASSURANCE

❖ QUALITY CONTROL

❖ MICROBIOLOGICAL DEPARTMENT

❖ ADL (ANALYTICAL DEVLOPMENT LABORATORY)

❖ F&D (FORMULATION AND DEVELOPMENT)

❖ PRODUCTION DEPARTMENT

❖ PACKAGING OF GENERAL AND ANTI-CANCER

PRODUCT

❖ CONTROL SAMPLE ROOM

❖ DISPENSING MATERIAL STORAGE DEPARTMENT

❖ WAREHOUSE

❖ DOCUMENT CELL

❖ ENVIRONMENT HEALTH AND SAFETY

❖ CONCLUSION

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INTRODUCTION
Neon Antibiotic Pvt.Ltd. was started by CEO, Shri Babulal K. Jain in 1990 and
later it was renamed as Naprod Life Science Pvt. Ltd. In 2006.

Naprod Life Science Pvt. Ltd. has a major market share in Anti-Cancer & General
Injection products (Propofol as anaesthetic & Antacids Injection). It is a
multinational company involved in production and distribution of General
Formulations (such as Antiviral, Antibacterial, Antifungal, etc), Anti-Cancer
Formulations (such as Anastrozole, Carboplatin, Docetaxel, Gemcitabine and
many other drugs), Anesthetic Formulations (such as Rocuronium
bromide,Vecuronium bromide, Atracurium, etc). Company has also started
manufacturing a wide range of new products like Colistimethate, methotrexate
and Topotecan.

It is specialized in the production of Lyophilized products and is one of the

pioneers in India in lyophilization. The Manufacturing unit is located in Tarapur,
Boisar in Maharashtra state and it is supported with four well equipped modern
offices in Andheri, Mumbai.

MILESTONES:

1965-Trading operation commenced

1985-Manufacturing plant went operational

1994-WHO Certification of Oncology Plant

2010- ISO Certification obtained

Since 2012 – INVIMA Facility Approved

2016- PICS Facility approved

2016- Dr.Reddy’s Business Partner Excellence Award

2017- CRISIL Rating: MSE*2 (Financial Strength High and Operating

Performance High

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2017- Best Employee Engagement Program of the Year 2017 for “Ummeed”
by ACEF

2019- Following and Implementing best Safety Practices at Factory,

Competition arranged by DISH Department.

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QUALITY ASSURANCE
1. IPQA (In-Process Quality Assurance):
▪ Manufacturing in-Process control checking.
▪ Sample (quality control).
▪ Line clearance.
▪ Control sample release.
▪ In-Process checks.
2. DOCUMENTATION:
▪ BMR (Batch manufacturing release), BPR (Batch preparation
release).
▪ MPI
▪ MS
▪ MFR
3. QMF (Quality Management System):
▪ Change control
▪ Deviations
▪ Incident
▪ CAPA (corrective action & Preventive action).
4. VALIDATION:
▪ Cleaning validation.
▪ Analytical method validates.
▪ Process validation.
5. AQA (ANALYTICAL QUALITY ASSURANCE) :
▪ Examination & documentation of all aspects of laboratory
management.
6. TRAINING DEPARTMENT:
▪ SOP-standard operating procedure.
▪ GMP-Good manufacturing practice.
▪ Data integrity.
▪ GDP-good department practice.

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7. STABILITY (Product Temperature/RH):
▪ Long term – approx. 25°c/60%Rh.
▪ Accelerate - approx. 40°c/75%Rh.
▪ Intermediate – approx. 30°c/65%Rh
8. AUDIT AND COMPLIANCE:

• INTERIAL-
- Self Inspection.

• EXTERNAL-
-Customer audit.
- Regulatory audit.
- Non-regulatory audit.
9. VENDER MANAGEMENT:
MATERIALS -

• Packaging materials-
- Vials
- Cartons

• Raw materials-
- API’S
- Excipient

• Miscellaneous-
- Hand gloves
- Garments

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QUALITY CONTROL DEPARTMENT
• Define: Quality Control is one or more organizational unit with defined
responsibilities for controlling, through checking or testing of the
products.

• Functions of QC Department:
➢ Raw material testing
➢ Finished product testing
➢ Packaging material testing
➢ Stability studies

A. Weighing Balance: To weigh the required quantity of substance.

B. HPLC (High Performance Liquid Chromatography):Used for
separation, identification and quantification of given solid sample.
C. GC (Gas Chromatography): Used for separation, identification and
quantification of given liquid sample.
D. FTIR (Infrared Spectrometer): Used for identification of functional
groups.
E. Karl Fischer Titrator: Used for determination of water content of
sample.
F. PH Meter: Used to determine pH of the sample.
G. Disintegration Apparatus: Determination of disintegration time of
tablets.
H. Dissolution Test Apparatus: Determination of dissolution time of tablets
and capsules.
I. Melting Point Apparatus: Determination of physical constant.
J. Friability Apparatus: Used to determine the likelihood of the tablet to
get break while handling.
K. Hardness Tester: Determination of hardness of tablets.
L. Tapped Density Apparatus: determination of flow property.
M. UV Spectrometer: Identification of concentration of unknown sample.
N. Polarimeter: To determine the optical activity of the drug.
O. Refractometer: To determine refractive index of the drug.
P. TOC: Used for determining the total organic carbon of water sample.

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STABILITY ZONE:
In stability zone drug products are kept under specified temperature and relative
humidity throughout its shelf life to check any undesirable reaction of the
product.

1) Stability Parameter 1 : 2°c-8°c (long term)

2) Stability Parameter 2 : 30°c/65%RH (long term)
3) Stability Parameter 3 : 40°c/75%RH (accelerated studies)
4) Stability Parameter 4 : 25°c/60%RH (accelerated or long term)

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MICRO-BIOLOGY DEPARTMENT
Microbiology department found very clean and free from micro-organism.
Microbial test are performed in sterile area and microbial growth is detected.
Practices in the department were so real and amazing to see & learn about the
equipment’s.

• Areas In Microbiology:
a) ONCO
b) General
c) Incubation area
d) Aseptic and sterile area
• Instruments Used In Micro-Biology Lab:
a) LAF (laminar air flow)
b) Incubator
c) Colony counter
d) Autoclave And Hot- air oven
e) Cold storage freezer

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• Media :
Media is important in microbiological tests for culture growth,
following type of media are used-
1. Buffered sodium chloride peptone solution(PH-7.0)
2. Soya bean casein medium (SCDM)
3. Sabouraud dextrose broth(SOB)
4. Mac-Conkey broth(MCB)
5. Entero-bacteria enrichment broth mussel ( EBM)
6. Rapp port vassiliadis salmonella enrichment broth (RVSB)
7. Soya bean casein digest agar (SCDA)
8. Sabouraud dextrose agar(SDA)
9. Mac-Conkey agar (MCA)
10. Cetrimide agar
11. Mannitol salt agar (MSA)
12. Violet red bile glucose agar (VBGA)
13. Triple sugar iron agar (TSLA)
14. Urea broth

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ANALYTICAL DEVELOPMENT
LABORATORY (ADL) :
• Operation performed in ADL:
- Determination of physical properties of drug
- Determination of chemical property of drug
- Stability testing
- Method development
- Method validation

Some fig. are as follows:-

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F & D (FORMULATION AND
DEVELOPMENT) :
The development of the new drugs and production of that drug has done in this
department. Product development may involve modification of the existing
product or its presentation.

• Machinery used in F&D :

a) Tablet compression machine (small scale)
b) Weighing machine
c) Raw material storage
d) Packing machine
e) Software formulation development
• Features:
a) Department flow/working process flow
b) Special product development capability
c) New product initiation

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PRODUCTION DEPARTMENT
Production department has-

1. GENERAL DEPARTMENT
2. ONEX DEPARTMENT

1] GENERAL DEPARTMENT:
Fig. Manufacturing area Fig. Component preparation area

• Process of Production of Injection:

Material procurement from approved area

Material receipt by warehouse

MRN preparation

QC sampling

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 QC approved

Dispensing

API- Excipient

Sterile bulk solution transfer to dose proportionate batch

fill Aseptic filling under grade-A operation

wt.
(Vertical enclosed laminar flow) with grade B background
check

Automatic half stoppering and transfer through conveyer blender LAF for
loading into lyophilizer under grade-A condition with grade-B

Lyophilization

Automatic vial stoppering in lyophilizer

Stoppard vial transfer for sealing through conveyer belt in grade-A condition
with grade-B background

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 Sealing of vials in vials sealing machine

- sealing
defect
Filled and seal vial visual inspection
- moulding
defect
Packing operation and commercial dispatch
-less cake,
shrink Test matter of carton,
label.

Overprinting details
on labels & carton

Good vials labelling, carton

Secondary packing

Lyophilizer:

• Machines Used In Process:

Fig: Filing machine Fig. vial loading area

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Fig. vial sealing Fig. External vial washing

2] ONEX DEPARTMENT
The Onex department has three types of dosage forms:

a) Injection
b) Tablet
c) Capsule

a) INJECTION :
• Production Process of Injection:

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 Dispensing of raw material
Line &clearance
activity for
manufacturing
equipment
Solution preparation with suitable size of

Manufacturing Vessel (under LAF)

Sampling of bulk solution by QA representative

Analysis of sample by QC

Bulk release from QC

Aseptic filtration solution through 0.2µ nylon 66 Pre & post filter integrity
membrane filter under grade-A check by Sartocheck
bubble point check

Common bulk solution transfer to dose proportionate batch (under LAF)

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 fill wt. Aseptic filling under grade- A operation
check
(Vertical enclosed laminar flow) with grade B background

Automatic half stoppering and transfer through conveyer blender LAF for
loading into lyophilizer under grade-A condition with grade

Sealing of vials in vials sealing machine

- sealing defect

-moulding defect
Filled and seal vial visual inspection
-less cake, shrink

Packing operation and commercial

Test matter of carton,
dispatch
label.

Overprinting details
Good vials labelling, carton on labels & carton

Secondary packaging

Fig. Pass box Fig. Manufacturing tank

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Fig. Compound isolator Fig. Changing room

Fig: Vial Inspection board Fig. Stabilizing zone

b) TABLETS:
Dispensing of API’s and excipient

Sifting (with sifter)

Dry mixing

Wet granulation (RMG, Granulating time impeller & chopper Speed)

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 Drying (With FBD, inlet, outlet temp)

Sizing of dry granules (with multimillion)

Cage Binder Blending Time

Blending and lubrication

Compression

Uncoated Tablet Coated Tablet

In process check

In process check Sampling Coating Coating

Sampling

AQL
Inspection / Sorting
Sample collect as
per BMR AQL &
check for defect

AQL
pass

Blister packing / strip packing / bottle packing

Secondary packing & coding

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 Transfer to Bound Storage Room

Fig. Blister packaging machine Fig. 27 station compression machine

c) CAPSULES :
Granules for capsules:

Dispensing of API’s and excipient

Sifting (with sifter)

Dry mixing

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 Wet granulation (RMG, Granulating time impeller & chopper speed)

Drying (With FBD, inlet, outlet temp.)

Sizing of dry granules (with multimillion)

Cage Binder Blending Time

Blending and lubrication

In process check
& sampling

Capsule filling and polishing

• Machines used:
Fig. Granulation Fig. Coating machine

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Fig. Inline homogenizer Fig. capsule machine

Fig. Sorting area

PACKAGING OF ONEX AND GENERAL

PRODUCTS
✓ Arrangements
✓ Labelling
✓ Information
✓ Secondary packing
✓ Sealing / closing

• Machines used:
➢ Striker labelling

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 ➢ Auto car toner machine
➢ 2D barcode machine
➢ Shrink tunnel machine

▪ After closing of product, checking is done by using 3 or 4 laser

system which separated the product which does not stand
quality.
▪ Packing of 10 packs is done and further pack into plastic cover
sealed by heating.
▪ Any weight variation in the pack will result in the buzzer of
alarm system, indicating the weight alteration.
▪ Further any pack of 10 is packed in the cardboard box which is
sealed and covered in the plastics.

Fig. Secondary packing Fig: Labelling machine

CONTROL SAMPLE ROOM

- In control sample room, sample of raw materials and final
products are stored.
- Before production, QA person stores the sample in control
sample room. QC person take the sample for QC testing.
- Samples are stored one year over expiry in control sample
room, thereafter these samples are destroyed.
- Samples are stored at 20°c-25°c temperature.
- Detector is placed to monitor temperature.

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- It keeps the sample record and with QA,QC and
Production department.
- Each container is marked with the lot number, name, and
status (released, quarantined and rejected).

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DISPENSING MATERIAL STORAGE
AREA :
• Final pack product ready for dispensing are stored in this room.
• Products are dispensed by order.
• Final product box is labeled by yellow label and dispensing
product box is labelled by green label.
• Products are dispensed throughout the market from this area.
• Final products are stored at certain temperature, normal
temperature range is 15°c to 25°c and the specific products are
stored at temperature 2°c to 8°c.

Fig. Storage area

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WAREHOUSE :
➢ In warehouse many types of materials are stored as following:
- Raw material
- Packaging material
- Lab chemical and general items
- Maintenance related items
➢ Store the material as per the status in area designated as
Quarantine, Re-test, approved, Rejected.
➢ Approved material are to be stored in designated approved store
as per the standard storage condition at temperature 15c°-25°c
and RH 40%-65%.
➢ Quarantine Raw Materials to be stored in designated quarantined
store as per the standard storage condition at temperature 15c°-
25°c and RH 40%-65%.
➢ Dispensed Raw Materials to be stored in designated dispensed
RM staging room as per the standard storage condition at
temperature 15c°-25°c.
➢ Solvent Raw Materials to be stored in designated solvent
material store as per the standard storage condition at
temperature 15c°-25°c.
➢ In case of materials having -20°c storage condition, it is stored to
the deep freezer (-10°c-20°c) of approved area.
➢ Sections clearly identified ( Quarantine, released, rejected)
▪ Quarantine ― yellow label
▪ Released ― green label
▪ Rejected ― red label
➢ QC generates pink colour “Restricted use only” label, and affix
the label on the container. Restricted use materials shall be
stored in quarantine area rack.

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• PROCESS OF STORAGE OF RAW MATERIAL
Receipt of raw material from the vendor
Materials stored in raw material staging area
De-dusting of material
Physical inspection for the contamination and damage of raw material
& container
Transfer the material to the quarantine area
Quarantine labelling

Inform to QC for sampling

QC sample (sample label)
Sample container return to the quarantine
If material rejected by QC
Transfer to rejected storage area
Materials approved by QC
Affix the approved label on each container
Transfer the material to approved material storage

Fig. : Approved raw material area Fig: Rejected material storage

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DOCUMENT CELL :

Document team shall take the final print. Document cell person shall
verify the document, make the stamp as ‘Originated from document
cell’ on the front page left side at the bottom below footer &then send
the document for approval signing.
Document cell stores the all documents and maintain the record of all
departments.
➢ All documents are stored department-wise, so that easy finding or
access to the document can be made easy.
Following records are maintained in document cell:
➢ Batch Manufacturing Record (BMR)
➢ Batch Packaging Record (BPR)
➢ Change Control Record
➢ Testing
➢ Investigations
➢ Training
➢ Maintenance
➢ Cleaning
➢ All documents of every department are maintained.

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ENVIRONMENT HEALTH AND
SAFETY
✓ Personal protective equipment’s required – Face shield / Safety
Goggle / Welding shield/ Safety Shoes / Apron / Hand-gloves /
Dust mask / Safety helmet / PAPR / Safety Belt / Lanyard
✓ Equipment’s& Tools required – Gas Cutter / Welding machine /
Drilling machine / Hack saw / Chisel & Hammer / Hand tools /
Safety torch / Portable lamp / Ladder / Scaffolding / Fire
extinguisher
✓ Occupational disease (approx. 29 diseases are identified in the
world)
✓ Effluent treatment (Neutralisation-ppt formation-slugging,
further solid is transferred to Bombay clearing plant), water is
transferred to oxidised machine known as oxidiser and further
go for radiation processes.
✓ Fire and sand filtration at the end of water collection
✓ Buzzers are established and heat metres also found to detect heat
change.
✓ Safety committee is established for further development.
✓ Various kinds of fire extinguishers are placed.

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CONCLUSION
Naprod Life Sciences Private Limited is a fully integrated, global healthcare
provider, with strengths all along the pharmaceuticals value chain.

The staff of all the departments are very helpful and provide lot of information
about instrumental working and they are supportive as well.

As Naprod Life Sciences Private Limited mainly deals with anticancer products
and General Injection Products, I have learnt about all the extra precautions which
are required for the Production, packaging, analysis etc. of the Anti-cancer drugs.

I am grateful and feeling satisfied after the training and the training helped me
with getting exposure about the industry which will be helpful in the future.

*****

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