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REPORT
UMAIR JAVED
NUTRIFACTOR LABORTORIES
PVT.LTD
All praises to ALMIGHTY ALLAH who is the supreme Authority Knowing the ultimate
relations underlying all sorts of phenomenon going on in this universe and whose
blessings and exaltation flourished my thoughts and thrived my ambitious to have the
cherished fruit of my humblest thanks to the Holy Prophet Hazrat Muhammad (Peace
be upon him) who is forever a torch of guidance and knowledge and knowledge of
humanity as a whole.
I deem it my utmost pleasure to avail this opportunity to express gratitude and deep
sense of obligation to my reverend teachers, for their valuable and dexterous guidance
scholarly criticism , untiring help, compassionate attitude , kind behavior, moral support
and enlightened supervision during the whole study. Being Muslims No
Acknowledgement Goes without Praising to ALLAH ALMIGHTY .Knowledge has no
boundaries and there is no end to it. This is what I have come to know while preparing
this report. It has been a good experience by taking training in NUTRIFACTOR
LABORATORIES PVT.LTD. The whole staff of organization was cooperative and helpful.
I sincerely express my thanks & gratitude to the honorable and respected Production
Manager Sir Zeeshan who provided me with an opportunity of internship and to write on
such a unique organization
Introduction.
Industry Overview.
Moto of Nutrifactor laboratories
Aim &Objective.
Products
Departments of Industry.
Toll Manufacturing.
Observation.
Discussion.
Conclusion & Recommendation.
INTRODUCTION
NUTRACEUTICAL INDUSTRY: INDUSTRY OVERVIEW
Nutraceutical product is a food or fortified food product that not only supplements the
diet but also assists in treating or preventing disease (apart from anemia), so provides
medical benefits. Nutraceuticals are not tested and regulated to the extent of
pharmaceutical drugs. Because of their strong dedication to high quality products and
services they have developed a great portfolio of International Clients, Toll Partners,
Institutional Buyers and Marketing.
This industry has all the essential Sections of Medicine. They have a layout according to
the international standard. Itis centrally air conditioned and have latest machinery.
Nutrifactor labortories is equipped with the modern equipment for production, quality
control and quality assurance. Envoy manufacture all forms of drug delivery systems
like, solid orals (tablets, dry suspensions), liquid orals.
MOTO OF NUTRIFACTOR LABORTORIES:
• To offer effective solutions for various healthcare challenges, with products and
services that are well-focused, within customers reach and contribute to improved
healthcare of the people of Pakistan.
Jointin-D
Ginkgo Focus
Vitamax Women
Magnesium 500mg
Glutathione
Lectamor
Magnesium 500mg
B-50 B-Complex
Nucal-Z
Lipozin
Glucofactor 30 Tablets
Ginseng 250mg
DEPARTMENTS OF INDUSTRY:
The Company is involved in the manufacturing of almost all segments of products
having its independent manufacturing sections which are controlled with centrally air-
handling system. There are following main departments of NUTRIFACTOR
LABORTORIES.
Ware house Raw Material Store Quarantine Area Finish Good Store
Production department
Quality control department
Procurement department
Business development department
I.T department
Marketing department
WARE HOUSE
PREMISES:
It is was well situated, well laid out, tidy, clean and well secured enabling good
preservation of raw material, packaging material and finished products.
Quarantine area
Packing material quarantine
Raw material quarantine
2. Excipient area
3. Active ingredients
4. Dispensing area
5. Chiller area
QUARANTINE:
All raw materials, components, packaging, and labeling materials are held in our
"quarantine" area until they are sampled, tested and/or examined, and released for use
by our "quality control laboratory". The sampling is performed according to specific
procedures by trained personnel.
Dispensing area:
Dispensing area is also present in raw material section where dispensing is performed
under manufacturing order of a product at time of dispensing. Personnel should be
present there to check the process of dispensing according to SOP.
• Production pharmacist
• Q.A pharmacist
• Raw material store pharmacist
• Raw material dispenser
The QCD collects the sample and reports for its release, it is according to the
specifications or rejection if not. After rejection from Quality Control Department, red
“Rejected” slip is pasted on each of the Quarantined material and the “Quarantined”
slip is removed.
After released by the Quality Control Department, green “Released” Slip is pasted on
each of the Quarantined material and the “Quarantined” slip is removed. The material
released information’s is entered in the material log sheet. The Store Keeper manages
to transfer the RM (Raw Material) to the bulk with necessary information pasted on it.
Two copies of GRN (goods receipt note) after release of RM (Raw Material) from QC
(Quality Control Dept.) are proposed. One copy of GRN is retained by store keeper and
one copy is send to accounts department for costing. The Store Keeper (Raw Material)
transfers whole the consignment of the material with the help of section workers by
means of trolley, lifter to the bulk store.
ISSUANCE OF RAW MATERIAL:
The weighing of raw materials is carried out in the presence of pharmacist. Production
Pharmacist checks all the Raw Material by weight/volume on the weighing balance
according to manufacturing order. After weighing, the raw material is transferred in the
relevant section of production department. The copy of the manufacturing order is kept
by the Assistant Store Manager for record and another copy is given to production
pharmacist.
DOCUMENTATION:
Following documentations were done in ware house at different stages:
Temperature/humidity chart.
Dispensing log book.
Raw material requisition.
Raw material analysis report.
Request for retest.
Certificate of analysis.
Issuance of slips
(Pink slip: material identification, Yellow slip: sampled at QC, Green slip: passed from
QC)
Warning in industry:
You are entering to Production Area please wear,
• Cap.
• Overall
• Shoes cover or change your shoes.
PRODUCTION AREA
Production team is committed to produce highest quality products, which can satisfy the
needs of both doctors and patients. The production team endeavors to manufacture
products that are cost-effective through best utilization of their resources. This
department is well equipped with latest equipment.
Cone Mixer.
De-humidifier.
Semi-Automatic Capsule Filling Machine.
Semi-Automatic Powder Filling Machine.
Production manager
Assistant production manager
Tablet section in-charge
Capsule section in-charge
Oral liquid section in-charge
Dry powder injectable section in-charge
Packing pharmacist
workers
TABLET SECTION:
A small, solid dosage form of a medication. It may be compressed or molded in its man-
-ufacture, and it may be of almostany size, shape, weight, and color.
DRY MIXING:
Ribbon mixer is used for mixing.
WET MIXING:
After dry mixing, wet mixing is done in the ribbon mixer.
WET GRANULATION:
Wet granulation is used for wet granulation and mesh size 4 & 6 are used.
DRYING:
FBD (Fluidized Bed Dryer).
Tray dryer is used for the purpose of drying.
OSCILLATING GRANULATOR
Oscillating granulator is used for dry granulation & mesh size used is 16.
COMPRESSION:
Rotary tablet machine is used for compression. Zp17and ZP-33 is being used.
COATING:
Alu-PVC.
Alu-Alu.
Tablets are packaged into strip and blister packaging and then finally in shippers.
1. Alu-PVC Packing:
Specification:
3 pinch.
Temperature 140-150°C.
Batch no. & Expiry date is printed.
Sealing foil.
CAPSULE SECTION:
“Capsules are solid unit dosage form of medicament.”
Capsulation process starts with dispensing of active ingredients. Weigh and dispense
system begins with a pharmacist getting a bill of materials for ingredients that make up
a recipe for a batch to be manufactured. Each material must be gathered from a
warehouse. Then it is verified as the proper material, carefully weighed, checked again,
and finally readied for mixing in the recipe.
2. FILLING OF CAPSULE:
3. CAPSULE POLISHING:
After capsule filling capsules were polishes in full automatic capsule polishing machine .
4. LABELING & PACKING:
Alu-PVC.
Alu-Alu.
Capsules are packaged into strip and blister Packaging and then finally in shippers
QUALITY CONTROL DEPARTMENT
The quality control department is responsible to ensure that all materials meet
the established criteria throughout all phases of the process. Raw materials,
components, and packaging and labeling are examined and tested according to a
rigorous written program designed to assure uniformity from batch to batch. Every raw
material received is tested for identity and conformance to specifications. Every bottle,
cap, and label is examined to assure that they match the written specifications. During
the manufacture of all batches of all products, in-process samples are tested and the
results documented. If any results fall outside of the written specifications, the product is
rejected and the information is submitted to the research and development group for
evaluation and further disposition. Samples of finished, packaged product are tested for
stability to allow for determination of expiration dating. Accelerated stability testing as
well as real time stability testing is done concurrently to validate the results of the tests.
QUALITY POLICY:
• To gain customer’s satisfaction through manufacturing and providing high quality
pharmaceutical products.
• To improve the standard of life through the value of developing innovative products by
research and development.
The ISO definition states that quality control is the operational techniques and activities
that are used to fulfill requirements for quality. Quality control is a process for
maintaining standards and not for creating them. The quality control department has the
responsibility and authority to approve or reject all components, drug product
containers, closures, in-process materials, packaging material, labeling, and drug
products.
Activities of Quality control department in were:
• Testing and release or rejection of all incoming raw materials, packing materials, in-
process / intermediates and finished products as per specified specifications.
• Maintaining testing records as per standard procedures for raw materials, packing
materials, in-process / intermediates and finished products.
• Follow safety norms at all the stage during handling of chemicals and using
instruments.
Raw Material
Receipt
Verification
Sampling
Under Test
Q.C Testing
Approved Rejected
For manufacturing
Return to supplier/Destruction
FINISHED PRODUCT INSECPTION :
Completion of Batch of Finished products
Sampling by Q.A
Under Test
Q.C testing
Preparation of Report & checking
Approved Rejected
For Dispatch Reprocess/ Destruction
Test for Raw Material For testing of raw material following test are performed
according to SOP or referenced set by supplier
Description or Physical appearance (crystalline, powder, smell, color,)
Solubility (solubility is check by dissolving in alcohol, chloroform or in water if
substance organic in nature and non-polar it will dissolve in alcohol and
chloroform and if substance is inorganic n polar in nature will easily dissolve in
water)
Identification (identified by using TLC, UV spectrometer)
pH (checked by pH meter pH should be within range as recommended by official
books)
Viscosity (viscosity is checked by viscometer and it should be within range as
recommended by official book)
Assay (percentage purity of sample is checked by analyzing the sample by using
U.V spectrometer or HPLC, FTIR but mostly used apparatus is U.V
spectrophotometer)
LOD/ Loss on Drying
Wt. of empty Petri-dish =A
Wt. of Petri-dish + Sample = B
Wt. of sample = B-A = C
UV/visible Spectrophotometer.
High Performance Liquid Chromatography.
Moisture Analyzer.
Polari meter.
Dissolution Apparatus.
Disintegration Test Apparatus.
Thin Layer Chromatography.
Hot Plate Magnetic Stirrer.
Viscometer.
Sonication Bath.
Melting Point Apparatus.
Refract meter.
Friability Apparatus.
Vacuum Pump Filtration Assembly.
Forced Convection Oven.
PH meter.
Conductivity meter.
Centrifuge Machine
Dead Weights.
Analytical Balance.
Desiccators
Atomic Absorption Spectrophotometer.
ELECTRONIC BALANCE:
Electronic balances have become standard equipment for many high school and college
chemistry departments. They allow the user to quickly and accurately measure the
mass of a substance to a level of accuracy impossible for traditional balances to
achieve. This is especially important in experiments that require precise amounts of
each substance to achieve the desired results. The popularity of the electronic balance
is also due to its extreme ease of use for any skill level.
Place the electronic balance on a flat, stable surface indoors. The precision of
the balance relies on minute factors and wind, shaky surfaces, or similar forces will
cause the readings to be inaccurate.
Press the "ON" button and wait for the balance to show zeroes on the digital
screen.
Use tongs or gloves to place the empty container you will use for the substance
to be measured on the balance platform. Fingerprints and other greases from your
hands add mass and must be avoided for accurate measurements. Press the "Tare" or
"Zero" button to automatically deduct the weight of the container from future
calculations. The digital display will show zero again, indicating that the container's
mass is stored in the balance's memory. Carefully add the substance to the container.
Ideally this is done with the container still on the platform, but it may be removed if
necessary. Avoid placing the container on surfaces that may have substances which will
add mass to the container such as powders or grease. Place the container with the
substance back on the balance platform if necessary and record the mass as indicated
by the digital display.
FRIABILITY TESTER:
Compressed powders in uncoated pills or sample tablets can easily shed small particles
during transport, compromising the integrity of medications or the safety of workers
exposed to reactive residues; this frustrating reduction into smaller pieces is known as
friability.
Friability testers test the degree to which a compressed substance will be reduced to
fine particles or fibers when affected by friction, pressure, or vibration. Tablets are
placed into a rotating single-chamber Roche drum or dual-chamber Varian drum (these
are industry terms of art; different vendors often have their own names for proprietary
drum designs). The user then selects test parameters based on the number of rotations,
time, or starting and ending sample weights. To accommodate high-throughput-
dependent workplaces such as pharmacies, some friability testers can handle multiple
sample types at once, and have pre-programmed test algorithms for commonly
assessed medications or substances. The difference between the weight before and
after the process is determined as Friability and should not exceed 1%, which is
considered an ideal percentage
DISINTEGRATION APPARATUS:
HPLC:
Basic Principle:
Separation is based on the analyte’s relative solubility between two liquid phases. HPLC
utilizes different types of stationary phase (typically, hydrophobic saturated carbon
chains), a pump that moves the mobile phase(s) and analyte through the column, and a
detector that provides a characteristic retention time for the analyte. Analyte retention
time varies depending on the temperature of the column, the ratio/composition of
solvent(s) used, and the flow rate of the mobile phase. With HPLC, a pump (rather than
gravity) provides the higher pressure required to propel the mobile phase and analyte
through the densely packed column .
HPLC – Modes:
With a wide range of flow rates, precise solvent flow and system pressure are
maintained with a built-in pressure unit. User-friendly pump heads are self-contained
units that can be rapidly exchanged by simply loosening a finger-tight clamp. PEEK and
titanium pump heads are available to protect biological samples from trace amounts of
metal ions that might be released from components in the fluid path.
UV SPECTROMETRY:
Basic Principle:
Unique Features:
Quartz over coating protects the optics from the environment and allows cleaning
without damage to their reflective surface. Sealed optics prevents exposure to corrosive
environments. The spectral bandwidth can be set down to 0.2 nm. A phase locked
wavelength drive prevents peak shifts and peak suppression at high scan speeds. The
large sample compartment gives more flexibility in sample size
QUALITY ASSURANCE DEPARTMENT:
Quality Assurance (Q.A) is the sum total of organized arrangements made with the
object of ensuring that product will be of the quality required by their intended use.
Quality assurance is the systematic monitoring and evaluation of the various aspects of
a project, service or facility to maximize the probability that minimum standards of
quality are being attained by the production process. QA cannot absolutely guarantee
the production of quality products.
Temperature check
Humidity checking
Line clearance (at different stages, in line clearance our focus is on cleanliness
proper identification of product batch No. packing procedure, product labeling)
Stability testing
Maintain record
Dispatch testing
Handling of market complains
Dispensing checking
In-process testing
SOP designing
Workers training
Validation
Self inspection / internal audit
Art work
Market return
In-process test for Tablets Q.C perform following test for in-process testing of tablets
Finished products are stored in this area. Temperature and humidity is controlled here
to assure stability and effectiveness of products. Products that require cold storage are
stored in refrigerator. Finished good received report is also signed.
After passing Q.C tests, quality products after manufacturing and packing are kept here.
And then products are supplied to different institutes etc.
Today NUTRIFACTOR LABORTORIES (Pvt) Ltd. products are being promoted & sold
in various countries (UAE) around the globe.
DISCUSSION:
Through this internship, I not only got the opportunity to experience but I also learnt the
applications of these theories in actual the application. I got to observe the whole
working environment of pharmaceutical industry & the important aspects regarding the
production of high quality pharmaceuticals & carrying out important quality control tests
to ensure that all the procedures carried out during production are according to GMP.
CONCLUSION:
Though serving on humanity is not only a person’s responsibility but also of community.
And this community comprises of all the members starting from the very first of disposal
of quality products. No work is penniless rather the knowledge it keeps in, internship at
any working area is a great learning experience in itself.
RECOMMENDATIONS:
I recommend that, without fully equipped institutes as well as qualified and devoted
personals, the profession of medicines will not flourish in a developing country like
Pakistan. If high paying careers continue to attract the best and brightest students out of
country, there will not only be a shortage of professionals in our place, but the
professionals available may not have the best qualifications. Therefore, it is necessary
to provide the best of facilities to the health professionals especially the pharmacists
because they play a vital role in ensuring health. Otherwise, our nation will suffer and
when nation suffers, the future suffers. And as an internee I want more time to learn its
very short duration for me to take a round of practical work especially in the quality
control area.
Lastly thanks a lot for giving me a chance to come here in NUTRIFACTOR and
becoming a part of its hard team, that’s all improve my knowledge and my skills.