Zentiva is a manufacturer of affordable medicines with a focus on quality and patient access, operating key production sites in Europe, including a significant facility in Ankleshwar, India. The document outlines various processes including tablet formulation, quality control, production, and packaging, emphasizing the importance of rigorous testing and adherence to Good Manufacturing Practices (GMP). Additionally, it details the equipment and methodologies used in manufacturing, ensuring that all products meet high safety and efficacy standards.

1. [1]
INTRODUCTION
Location:-
Zentiva is a producer of high-quality affordable medicines serving patients in Europe
and beyond. With a dedicated team of more than 4,700 people and a network of
production sites - including flagship sites in Prague, Bucharest and Ankleshwar -
Zentiva strives to be the champion of branded and generic medicines in Europe to better
supportpeople’s daily healthcare needs. At Zentiva it is our aspiration that healthcare
should be a right and not a privilege. More than ever, people need better access to high
quality affordable medicines and healthcare. We work in partnership with physicians,
pharmacists, wholesalers, regulators and governments to provide the everyday solutions
that we all depend on.
About Zentiva’s Ankleshwar site
Established in 1987, the Ankleshwar manufacturing site has a chemistry and
biotechnology development center, and manufactures both intermediates and
pharmaceutical formulations. A large producer of tablets, the Ankleshwar site
manufactures more than 6 billion tablets annually.
Mission &Values:-
Zentiva is a leading developer and supplier of high-quality affordable prescription
medicines and consumer brands. As Zentiva grows more people get the medicine they
need. Our business is built on trust and responsibility with the patient at the heart of
everything we do. Zentiva has established 6 shared SuperpowerZ which frame the
values and behaviours we expect of our team and how we will build a healthy business
that we can all be proud of.
GIDC Estate Ankleshwar
393002, Dist. Bharuch ,Gujrat India

2. [2]
TABLET-SECTION
Tablet:-
A tablet is a mixture of active substances and excipients, usually in powder form,
pressed or compacted into a solid. The excipients include binders, Glidants (flow aids)
and lubricants to ensure efficient tabletting, disintegrates to ensure that the tablet breaks
up in the digestive tract; sweeteners or flavors to mask the taste of bad-tasting active
ingredients; and pigments to make uncoated tablets visually attractive. A coating may
be applied to hide the taste of the tablet's components, to make the tablet smoother and
easier to swallow, and to make it more resistant to the environment, extending its shelf
life.
Advantage
 Production aspect
 Large scale production at lowest cost
 Easiest and cheapest to package and ship
 High stability
• User aspect (doctor, pharmacist, patient)
 Easy to handling.
 Lightest and most compact.
 Greatest dose precision & least content variability.
 Coating can mark unpleasant tastes & improve pt. acceptability.
 PHARMACEUTICAL PRODUCT BY ZENTIVA PHARMACEUTICAL
PVT.LTD:-
1. Avil -25 mg
2. Trental-400
3. Paracetamol-500mg
4. Ramilich-( 5, 25mg)
5. Ramipril-25mg
6. Zuglimate-500mg
7. Clopidogrel-75mg
8. Metformin-100mg
9. Metformin lich-( 850, 1000mg)
10. Ibuflame-600mg
11. Xanirva-(15, 20mg)
12. Lasix-40mg
13. Trombex-75mg

3. [3]
QUALITY CONTROL AND QUALITY ASSUARANCE
Quality control is the part of GMP that deals with sampling, specification, and testing,
as well as organisation, documentation, and release procedures to ensure that necessary
and relevant tests are performed and materials are not released for sale or supply until
their quality is judged satisfactory.The items are only released after extensive testing in
accordance with strict specifications, methods, and procedures created in accordance
with international guidelines. The Quality Control (QC) laboratory assures that the
products are pure, safe, and effective. EU cGMP, MHRA, WHO, TGA, etc.
One of the most important elements in QC laboratory programme is the quality and
assurance of the standard, which are used.
In the pharmaceutical sector, quality control is a crucial process. Drugs must be
advertised as being stable, predictable formulations that are clinically effective. A faster
rate of new and improved pharmaceuticals is being created. Additionally, more stringent
and advanced analytical techniques are being created for their examination.
Different Types Of Test Are Performed For Different Material In Qc . And Types
Of Test Performed For Each Material Are As Follows:-
1. Testing Purified water
2. Assay of different tablet
3. Disintegration Test
4. Dissolution Test
5. In Process Quality Control
6. HPLC – High Pressure Liquid Chromatography
7. Testing Uniformity of Weight of Tablets
EVALUATION
 Organoleptic Property:- Colour Distribution Must Be Uniform With No
Mottling. For Visual Colour Comparison Compare The Colour Of Sample

4. [4]
Against Standard Colour. The Presence Of Odour In A Batch Of Tablet Indicates
A Stability Problem Such As The Characteristics Odour Of The Tablets
 Size And Shape:- Thickness: ±5% of standard value control to facilitate
packaging. shaped tablet requires slotted punches because of the non-uniformity
force during compression
 Hardness And Friability:- Both for tablet strength testing. Force required to
break a tablet in a diametric compression test is called hardness, also called tablet
crushing strength.
Friability is the resistance shown by the tablet during packing and transshipment.
 Friability tester:- A tablet friability tester is used to determine the tablet’s
durability during the packing and shipping operations. Using a revolving drum
with a baffle, a sample of tablets is dropped repeatedly over a set period of time.
 Roche friabilator
 Revolution at 25 rpm for 4 minutes (100 rev.)
 Dropping from 6 inches
%Friability = (Initial weight- Final weight)/ Initial weight × 100
Disintegration :-
 Test Tube And
 3 Inch Long
 10 Mesh Screen
 1l Beaker Of Water (0.1n Hcl) Simulated Gastric Fluid Or Simulated Intestinal
Fluid
 -6 Cm

5. [5]
 Frequency 28-32 Cycle/Min
Tablet Should Remain 2.5cm Below The Surface Of Liquid On Their Upward
Movement And Same For Downward Movement. The Potency Of Tablet Is Expressed
In Mg ,G, µg. Official Range Is Not Less Than 95%. Majority Of Tablets Has Their
Disintegration Time Of 30 Min.
Instruments and Devices seen in QA/QC
 Hot Air Oven.
 Dissolution Test Apparatus.
 Vacuum Oven.
 Bulk Density Apparatus.
 Membrane Filter.
 Conductivity Meter
 Halogen Moisture Balance
 Gas Chromatograph
 Melting Point Detector Viscometer
 Muffle Furnace.
 Centrifuge.
 Magnetic Stirrer
 3Ultrasonic Bath.
 UV Cabinet.
 Bursting Strength Test Apparatus. UV-VIS Spectrophotometer. (Ultra Violet
Visible)
 FT-IR Spectrophotometer.(Fourier Transform Infrared).
 Karl Fisher Titration.
 HPLC system Polarimeter
 Digital pH meter

6. [6]
Production Section:-
 Ensure area and equipment cleanliness before starting the manufacturing
operations.
 Check and ensure that all manufacturing equipment and other required
accessories are clean ready for use.
 Wear gloves and nose mask during all manufacturing process.
 Counter check the weights of all ingredients before using in the batch.
 Get line clearance from QA for manufacturing.
 Air handling unit (AHU) system should be kept ON throughout the
manufacturing process.
 Temperature should be kept between 25ºC ±2ºC and relative humidity should be
kept between 50±10%.
 Ensure that only QC approval purified water is being used for manufacturing
purpose
 Always transfer solution to the manufacturing vessels through 20 meshes.
 During the preparation of this product, no other product processing should be
done in the same area.
 During the preparation of this product, no other product processing should be
done in the same area.
 Whenever sifting through SS mesh is involved; check the mesh integrity before
and after use.
 All critical aspects during manufacturing like temperature, duration of mixing,
weight, etc. must be checked and recorded by the supervisor.
 Supervisor to ensure completion of all in-process records during various stages
of manufacturing operations till completion of the batch.
 Release from QA should be taken from all in-process tests mentioned in batch
manufacturing record
 No over writing is allowed in batch manufacturing record. If initial data is wrong
entered, cancel the data by single stroke arrow and put initials. Record reasons
for change as footnote on the same page
 All the details whatever is necessary should be recorded in batch manufacturing
record (BMR).
 Send a test request form to QC after manufacturing is completed
 Check all polyethylene bags before and after material loading for black particles
and sealing.
 Check calibration of respective equipment/machine before use.

7. [7]
Tablet component and Additives:-
API:- Active Pharmaceutical Ingredients.
Non-active Ingredients
a. Diluents:- starch, lactose, mannitol, sorbitol
b. Binders:- acacia, gelatin, Tragacanth, Calcium lactate trihydrate granular N.F,
Starch paste, polyvinyl pyrollidone, sodium alginate.
c. Lubricant:- Stearic acid, Magnesium stearate, Calcium stearate and Talk
d. Disintegrates:- Starches and most common disintegrants e. Colous: D&C and
FD&C Dyes and lacquers.
RAW Material: Anyone with a good touch in the pharmaceutical industry will be
very much familiar with all these categories. This categorization will clearly distinct
the materials from each other and also make it possible for us to have a clear line of
distinction between the materials that can be handled separately. Also, these
pharmaceutical raw materials are generally supplied to the pharmaceutical
manufacturing industries category wise to be sure of the materials being used and
produced. To reap the price advantage available on seasonal raw materials.
Dispensing:- Each ingredient in the tablet formula is weighed and accurately
dispensed as per dose. This is one of the critical steps in any type of formulation
process and should be done under technical supervision.
Channel:- Temprature
Channel

8. [8]
Granulation:-
There are three methods of preparing Tablets. These are:
 Wet granulation
 Dry granulation (also called slugging)
 Direct compression.
Wet Granulation:-
 Mixing of drugs and excipients o Mixing of milled powder
 Preperation of Binder solution
 Mixing of binder solution with powder mixture to form wet mass
 Coarse Screening of wet mass using 6-12 mesh
 Drying moist granules
 Screening dry granules with lubricant and disintegrants
 Mixing screened granules with lubricant and disintegrants
 Tablet compression
Dry Granulation:-
 Milling of drugs and excipients
 Mixing of milled powders
 Compression into large, hard tablets called slugs
 Screening of slugs
 Mixing with lubricants and disintegrating agents
 Tablet compression
Direct Compression:-
 Milling of drugs and excipients
 Mixing of ingredients
 Tablet compression

9. [9]
Milling Equipments:-
 Rapid Mixing Granulator (RMG)
 Steam Kettle
 Fluid Bed Dryer (FBD)
 Vibro Sifter with Loader
 Tippler and Co-Mill
 Rimek Communiting Mill
 Conta Blender
 Compressor
Rapid Mixing Granulator (RMG):-
RMG was developed for the pharmaceutical and chemical industry. With the help of
MRG Wet sieving is usually no longer necessary. After mixing the dry ingredients, wet
granulation occurs (without transferring the dry mixture) which produces large granules
in the RMG. RMG is specially designed to meet the GMP requirements of the
pharmaceutical industry.
Fluid Bed Dryer (FBD):-
In FBD, fluidized bed air vapor is introduced by a fan or blower mounted at the top
of the equipment. The air is heated to the required
temperature in the air heater and goes upward
through the wet materials, remaining in the drying
chamber equipped with a supporting wire mesh. at
the bottom. By this process, the material is
suspended and agitated in a warm air steam while
the granulation is maintained in motion.

10. [10]
Vibro Shifter With Loader:-
The shifter is a device used to filter the tablet's
ingredients with a reproducible mess ware. This
method involves the placement of power mess
particles on a screen with a uniform aperture. The
vibrator that is affixed to the sifter aids in sieving the
materials through the mesh. The mechanism of action
is to allow entrapped sub sieve particles to reach the
screen surface by loosening the parking of particle in contact with the screen surface.
Mixing:- Mixing is defined as the unit operation that combines two or more components
together by agitation, shear or mixers.
The final product of mixture contains
uniform distribution of both
components of mixture. (Example of
mixers: Blenders, Planetary mixtures,
Propellers etc.)
Compression:-
This step involves consistent flow of an adequately lubricated, uniform blend, into dies
where the granules are being compressed into
tablets. Compression is to be carried out as
per batch manufacturing record. Collect the
samples at various stages i.e. at start up, high
RPM, low RPM, low weight at target speed,
high weight at target speed, initial, as
per batch manufacturing record. Collect the
samples at various stages i.e. at start up, high

11. [11]
RPM, low RPM, low weight at target speed, high weight at target speed, initial,middle
and end of compression and carry out the testing of content uniformity and physical
parameters such as hardness, thickness, friability etc.In compression stage three batches
i.e. Batch No I, II and III shall be considered for validation. Compression results of all
the batches are well within the acceptance criteria results of the compression at different
speed, low weight at target speed, high weight at target speed, initial, middle and end of
the compression.
Coating:-
Tablets may be coated for a variety of reasons, including protection of the ingredients
from air, moisture, or light. Tablets are also coated to protect the drug against
decomposition or to disguise or
minimize the unpleasant taste of certain
medicaments. Coating also enhances the
appearance of tablets and makes them
more readily identifiable. In addition,
coatings can be resistant to gastric juices
but readily dissolve in the small
intestine. These enteric coatings
can protect drugs against
decomposition in the acid environment
of the stomach. Coating is to be carried
out as per batch manufacturing record.
Samples are collected at the end of coating stage and carried out the testing of content
uniformity and identification tests, related substances, individual impurities, and
physical parameters such as hardness, thickness, friability, etc. In coating stage three
batches i.e. Batch No I, II and III shall be considered for validation. Coating results of
all the batches are well within the acceptance criteria.

12. [12]
IPQC: (In Process Quality Control)
 Checks performed during production in order to monitor and, if necessary, to adjust
the process to ensure that the product conforms to its specifications. The control of
the environment or equipment may also be regarded as a part of inprocess
control.In-process controls are usually performed within the production area. The
performance of such in-process controls should not have any negative effect on the
quality of the product or another product.
 In-process inspection and testing should be performed by monitoring the process
or by actual sample analysis at defined locations and times. The results should
conform to established process parameters or acceptable tolerances.Work
instructions should delineate the procedure to follow and how to use the inspection
and test data to control the process.
Different Types Of In-Process Control:-
 Environmental control
 Building and equipment control
 Control of records
 Manufacturing control
 Packaging control
 Labeling control
 Warehousing control
 Finished product control
PACKAGING AND LABELLING
Packing technology is the process of enclosing or protecting a product for distribution,
storage, sale, or use. The process of designing, evaluating, and producing packages is
also referred to as packaging. Packaging is a coordinated system of preparing goods for
transportation, warehousing, logistics, sale, and end use. It can be useful to organise
packages by layer or function.

13. [13]
 Primary Packaging
 Secondary Packaging
 Tertiary Packaging
Primary Packaging:- Primary packaging is the material that first encases and holds
the product. This is typically the smallest unit of distribution or use, and it is the
package in direct contact with the content.
Secondary Packaging:- Secondary packaging is used outside of primary packaging to
prevent pilferage or to group primary packages together.
Tertiary Packing:- These are used for bulk handling, warehouse storage and transport
shipping. The most common form of palletized unit load that packs tightly into
containers.
TYPES OF PACKAGING
Blister Packing:
This is useful for packaging of unit dose of pharmaceuticals. This packing mode has
been used extensively for several good reasons. It is a packaging configuration capable
of providing excellent environmental protection, coupled with an aesthetically pleasing
and efficacious appearance. It also provides user functionally in terms of convenience,
child resistance and now temperature resistance. The blister package is formed by heat
softening a sheet of thermoplastic resin and vacuum drawing the softened sheets of
plastic into a contoured mould. After coming, the sheet is released from the mould and
proceeds to the filling station of the packaging machine. The semirigid blister previously
formed, is filled with the product and lidded with a heat sealable backing material. The
backing material can be either a push through or peelable type. For a push through type
of blister, the backing material is usually heat seal coated aluminum foil.

14. [14]
Strip Packing:
The strip packing is done by aluminum foil or glassine poly paper. A strip package is
formed by feeding two webs of a heat sealable flexible film through either a heated
crimping roller or a heated reciprocating platen. The product is dropped into the pocket
formed prior to forming the final set of seals. A continuous set of packets is formed,
generally several packets wide depending on the packaging machine’s limitations. The
strip of packets is cut to the desired number of packets in length. The strips formed are
usually collected and packed into a folding carton. The product sealed between the two
sheets of film usually has a seal around each tablet, with perforations usually separating
adjacent packets.
Bulk Packing:-
The packaging of the final product is done in paper cartons, manually, and is finally
sealed using an automatic sealer. The machine can seal cartons.
Raw Material And Finished Goods Section
Company Machine’s:
 IMG- PG A200 (Packaging Machine).
 IMG- IC 150 (Packaging Machine).
 Anta us Vision (Serialization Machine).
 Techno four Electronics PVT.LTD [600-HSA]/[1200] (Weight Machine).
 Nordson (Gum Machine).
 Autocartonator.
 SA Company (Weight Machine).
 HV1 CAM 350 CAM COMPANY (Packaging).
 TW India PVT.LTD. (Packaging).
 Shubham Machine (Packaging).
 ACG World Wide (Inspection Machine).
 CVC (Polyno Machine / Re Electric Motor).

15. [15]
 CPM 13 Machines.
 Conveyor belt (Good Collected Cartons).
 ALMAC (Packaging).
 ROTAVAC (Packaging).
 CIPRO 180/160(Packaging).
 C350 (Packaging).
 230XT (Packaging).
 TULSI RMG.
 ACG Inspection (Inspection Screen).
 FETTE- (Compression machine).
 Cad press (Compression machine)
 ACG500L- (Coating machine)
 Sign ode FTM 500 (Packaging Machine). Etc....

16. [16]
CONCLUSION
In the end I am glad to tell you that training in ZENTIVA PRIVATE LIMITED. DIST
–BHARUCH ANKLESHWAR GUJARAT Was an excellent and fabulous
experience. during the training I actually learned about the pharmaceutical company and
above its working the theoretical knowledge is worth for getting a degree, and it is
accessible in the book. We can only imagine about the think we read ,but practical life
is always different and excellent one. During my training period, I had seen the various
instrument and apparatus in the industry. The highly sophisticated instruments that work
precisely must be operated with intense care for optimum use. We could acquire a lot
of information regarding thee latest instruments and their working procedure.
I was sucessfully able to complete my short venture of training. Lastly I hope that my
training report fulfill the intended requirements.