TABROS PHARMACEUTICAL

COMPANY

INTERNSHIP REPORT

SUBMITTED BY
ANUM ASHFAQUE

ACKNOWLEDGEMENT

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 First of all I would like to express my gratitude to Almighty Allah for enabling me to
complete this report on In-plant Training.

I express my heartiest thanks and gratitude to the authority of TABROS Pharmaceutical

Company and the HR depart especially SIR MAAZ (Sr. HR MANAGER) for giving me the
internship opportunity. I am deeply grateful to all those who have given me their valuable time
and energy to express their rich full experience about the instrumental terms, conditions and
working procedures especially MISS ASMA(Sr.QC OFFICER),MISS
AMBER(SR.PRODUCTION OFFICER),MISS RABIA(Sr. PRODUCTION OFFICER)
MISS MADIHA(QA VALIDATION OFFICER),MISS ARBISH(QA OFFICER).

I am pleased to say that I have completed my one month internship in TABROS

Pharmaceutical Company. During my internship I observed different areas such as
Warehouse, Quality control, Quality assurance, Production areas, Packaging Areas and
Engineering Areas. We also gathered knowledge about Administration, Production Planning and
Total Quality Management system etc. All the officers and employees of TABROS Pharma are
conscious about their responsibilities. I am really thankful to the authority and all the officers
and employees for their sympathetic attention, advice and guidance.

QUALITY CONTROL DEPARTMENT

RAW MATERIAL TESTING:
Raw materials are tested to establish their identity, purity, and quality. This analysis is a critical
step in the manufacturing of pharmaceuticals and ensures that the product is suitable for its
intended use.The raw materials are tested by the QC analyst. They uses USP method and
perform different tests to determine whether the raw material is upto the standard or not if the
material gives positive response then they forward the release slip.

FINISHED GOOD PRODUCTS:

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A medicinal product which has undergone all stages of production including packaging is called
finished product. This includes

 Assay
 Identification
 Uniformity of content / uniformity of dosage units
 Disintegration test
 Friability test
 Single and multi-point dissolution testing

MICROBIOLOGY:
Microbiological testing plays an important role in the production of pharmaceutical drug
substances and drug products. Pharmaceutical microbiological testing is essential for patient
safety as the patients consuming the medicines might already be in a compromised position and
easily susceptible to infections. I have learned different test here which includes:

 Area monitoring by plate exposure and air sampler

 Microbial limit tests
 Total bacterial counts
 Total fungal counts
 Detection of pathogens

INSTRUMENTATION:
I have learned how to operate different instruments including spectrophotometer, HPLC,
friabilator, disintegration and dissolution apparatus.

DOCUMENTATION:
The data analyst make improvement in the SOP’s according to the latest edition of USP and the
records of each sample released is also feeded by the QC in the computers and the log books.

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QUALITY ASSURANCE DEPARTMENT
SOP’S AND DOCUMENT AUDIT:
I have read SOP’s which aim to achieve efficiency, quality output and uniformity of performance,
while reducing miscommunication and failure to comply with industry regulations.

I learned how to audit documents there is a envelop in which a list of documents are present
which includes dispensing slips, production order, QC release slips, Standard manufacturing
procedures, line clearance slips, finished good transfer note, reconciliation and destruction
certificate if all these documents are present with proper signatures of QA and production
officers then the auditing is complete.

LINE CLEARANCE:
Line clearance is a process in which the line or area is free from any unwanted residue or left
over of previous processing’s before proceeding for next process. QA officer has to provide Line
clearance before the start of any activity whether it is batch to batch change over and Product to
product change over.

INPROCESS CONTROL FIRST FLOOR AND GROUND

FLOOR:
In-Process Control are commonly understood as checks being performed during a Production
process for the purpose of monitoring and if necessary, to adjust the process to assure that the
Product confirms to its specifications. They are usually part of the documentation. I learned how
to do IPC for optical checking ,packing and filling of ampoules and vials, oral dry powder (ceph
and non-ceph) and semi solid manufacturing.

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VALIDATION:
Validation is the process of establishing documentary evidence demonstrating that a procedure,
process, or activity carried out in testing and then production maintains the desired level of
compliance at all stages. In the pharmaceutical industry, it is very important that in addition to
final testing and compliance of products, it is also assured that the process will consistently
produce the expected results.The field of validation is divided into a number of subsections
including the following:

 Equipment validation
 Facilities validation
 HVAC system validation
 Cleaning validation
 Process Validation
 Analytical method validation
 Computer system validation

APR(ANNUAL PRODUCT REVIEW):

An Annual Product Review must be conducted for each commercial product. The purpose of
this annual review is to verify the consistency of the process, to assess trends, to determine the
need for changes in specification, production, manufacturing and/or control procedures and to
evaluate the need for revalidation.

Annual Product Reviews (APRs) are important for communication between manufacturing,
quality and regulatory Affairs, to enable quality improvement processes. It can be divided into
four types.

 Technical review
 Production review
 Change review
 Quality review
 Analytical review

PRODUCTION FIRST FLOOR

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INJECTION MANUFACTURING AND FILLING:
The ampoules are arranged in a container. All the ampoules are washed by D.I water and then
sent to the drying chamber. After drying, the ampoules enter the liquid filling area where it is
filled and sealed.

OPTICAL CHECKING:
The vials are optically checked by the workers. There are two board available in black and white
color, the worker shake the ampoule and see the ampoule pointing towards the board. If there is
any impurity or particle present inside the ampoule then it’ll be rejected.

VIALS AND AMPOULE PACKING:

The ampoules are packed manually by the workers. The production officer keep control of every
little detail like maintaining cleanlines and controlling humidity and temperature in the area,
making destruction certificate and all relevant documents. They also make sure that the QC
slips must be present on the working stations and checking the batch no, mfg and expiry date.

DRY POWDER AREA(CEPH AND NON CEPH):

Packing order is given to the store and then the next day the active and excipients is received
by the ceph and non-ceph depart and then the raw material got sieved by the granulator then it
goes into the blender after blending the sample goes to QC for testing after getting release slip
from QC the labeling and packing of bottles started.

SEMI SOLID MANUFACTURING:

The packing order is given to dispensing depart then the excipient and active are given to the
manufacturing depart then the raw material is blended into the machines then the mixture is
transferred into the filling machines make sure that the hopper is completely cleaned and dried
after that the tubes gets packed in master cartons.

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 PRODUCTION GROUND FLOOR
GRANULATION:
The area should be cleaned including the mixers , granulators and double cone blenders.
Previous batch products shouldn’t be placed. Humidity and Temperature should be maintained.
The production officer should identify the raw material properly. Weight of dried granules should
be noted in the BMR and the documents of IPC should be checked.

TABLET COMPRESSION:
The granules comes from the granulation depart are then sent to the compression depart where
the granules got compressed by compression machine. Then the production officer performs
friability test, weight variation tests and hardness test.

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COATING:
Tablets from the compression depart is then sent to coating depart where the external surface
of tablet is coated by using a thin film of coating material. The closed drum rotate continuously.
The coating medium sprays automatically in a rational manner, in order to avoid excess coating
of tablet.

TABLET PACKING:
The tablet from the coating depart then sent to the tablet packing depart where the workers do
tablet sorting after that the tablets are transferred to the blister packing machines. The machines
are of two types one is Alu/Alu and another is Alu/PVC.

SACHET PACKING:
The sachet filling machine works by first printing onto the sachet material then forming it into a
tube shape, heat-sealing the rear, sealing the bottom, filling with the desired volume of
substance from the hopper at the top of the machine then simultaneously sealing and cutting
the top to create a fully sealed sachet and then sent to the sachet filling depart.

SYRUP MANUFACTURING:
Pharmaceutical syrups are produced by mixing purified water, sweeteners, active ingredients
(API), aromas, flavours and other ingredients (thickeners) etc.

The manufacturing process must achieve the following factors:

• Dissolving of the sugars to form a syrup

• Hydration of powdered ingredients

• Blending ingredients of widely different viscosity

• Suspension or dissolving of active ingredients

• The end product must be smooth, agglomerate-free and homogeneous.

• Equipment should conform to GMP standards