INSTITUTION OF HEALTH AND MEDICAL SCIENCE

DEPARETMENT OT PHARMACY
COURSE : PHARMACUTICAL MANUFACTURING
TITLE: PHARMACEUTICAL COMPANY VISET

REPORTED BY GROUP ….3

EAST AFRICA PHARMACEUTICAL P.L .C
• This pharmaceutical campaign is one of the first privately owned joint
foreign investment pharmaceutical factory established in 1996 G.C by
British and Sudanese investors with the intention of producing
human and veterinary medicine
CONT......
• it was the first of its kind to manufacture veterinary medicine mainly
for Ethiopian market and partially for selected neighboring African
countries and middle east markets
• the company has well established production ;QA, QC , marketing ,
logistic and supply chain and also Engineering and with highly
experienced senior technical staff
CONT......
• Currently, EAP has two product line those are
• Tablet and Capsule and is engaged in production of about 40 varlets
of medicines for local market all its two productions lines are
separated with unidirectional flow and fulfill good manufacturing
practices requirement
CONT....
• The production lines annual production capacity is declared as
follows;
• Tablet human production line capacity ;500,000,000
• Capsule human production line capacity ;300,000,00
• The company has more than 157 permanent employees with different
professions some of this include ;Pharmacist ;chemist ;Engineering
and senior Mechanics
CONT.......
• This complain has three sections those are raw material storing and
packing, finished product storing, human and animal active
pharmaceuticals ingredient store and quality control sections
1. RAW MATIRALS
• In this room active pharaceutical ingredients and additives are stored.
All materials are labeled properly; the materials that are not approved
labeled in yellow and shelved isolate.
• Packing materials for capsule and tablets are also stored there.
• The raw material are properly Weighted in this room which passed to
the production room.
• Vender list are used to issue and received pharmaceutical materials.
2. PACKING MATIRAL STORE
• Packing materials are divided in to two those are primary and
secondary packing material.
• 1 primary packing material it is packing material direct contact with
pharmaceutical product like capsule and tablets e.g. PVC and
aluminum
• 2 secondary packing materials it is packing material does not direct
contact with pharmaceutical product e.g. box, leaflet labeling paper
CONT....
• On the packed carton there are 3 color code to identify the product
stage and whether the product is qualified or not
• Yellow indicate quarantine mean the received raw material not
approved
• Green indicate the product approved
• Red means rejected
QUALITY QONTROL ROOM
• In this room there are quality control department which approved the
quality of the pharmaceutical product.
• In analytical process they use distilled water and its PH between 5
and 7 conductivity also less than one. They used numerous
equipment’s like
• UV apparatus
• Auto HPLC
• Dissolution apparatus
CONT.....
• Stability chamber (are used to identify the shelf life of the drug they
work in two ways at different humidity and temperature for the first
method work at temperature 40 0C ,humidity 75 0C.
• The second method at temperature of 30 0C , humidity 65 0C.
 SUMMARY
• This east Africa pharmaceutical company was established in 1996 GC
and produced different kinds of pharmaceutical productions.
• In this visit we aware how to store raw materials and finished
pharmaceutical also the mechanism of the quality control of the
pharmaceuticals product.
• Therefore the objective of this company to the expand the production
of tablet and capsules for chronic disease like diabetes and
hypertensions.
 PART TWO VISIT
• SINO-ETHIOP ASSOCIATE
AFRICA (SEAA)
OBJECTIVE
• To understand the empty hard-gelatin capsule
production process.
 BACKGROUND
• Sino-Ethiop Associate (Africa) plc (SEAA), a pharmaceutical was
established in March 2001 in Addis Ababa
• with a partnership of two Chinese Companies (China Associate Group
& Dandong JINWAN Group) and an Ethiopian Company, ZAF
Pharmaceuticals PLC to develop and market EMPTY HARD GELATIN
CAPSULES (EHGCs).
• Its shareholders have long experience in pharmaceutical business &
manufacturing.
CONT.....
• SEAA is a sole producer of Empty Hard Gelatin Capsules in sub
Saharan Africa.
• Driven by its customers’ distinct experience and focused on market
success, SEAA delivers high quality two piece empty hard gelatin
capsules in different sizes & colors. Its products comply with PICS &
WHO standards.
• Continuous quality improvement is pursued through a Quality
Assurance Program which ensures consistency, uniformity, and
conformity.
 BODY
• Our visit was started from observing the utility room.
• In the utility room there were different machines like air handling, temperature
monitoring, chiller machine etc.
• an air handling unit is used to recondition and circulate air as a part of a heating,
ventilating and air conditioning system.
• The basic function of the air handling unit to take in outside air, recondition it and
supply it as fresh air to a building. ·
• Chiller system for supply of chilled water for cooling of process systems,
environment and adjustment of humidity in production areas.
• Boiler unit for furnishing hot running water as well as temperature control of the
production areas Water treatment unit to produce Purified water of standard
specification.
CONT....
• Chiller system for supply of chilled water for cooling of process
systems, environment and adjustment of humidity in production
areas.
• Boiler unit for furnishing hot running water as well as temperature
control of the production areas Water treatment unit to produce
Purified water of standard specification.
CONT....
• Secondly we observed raw materials room that are imported from
abroad country ( Germany) .
• This raw materials are made from bones and used for gelatin preparation.
• This raw materials are made from bones and used for gelatin preparation.
• Sino-Ethiop Associate Africa PLC (SEAA) produced only the empty hard
gelatin capsule.
• For the production of the hard gelatin capsule many machines are used,
for example semi-automatic capsule production machine, capsule joining
machine, capsule separation machine.
CONT...
• All materials and inputs required to produce capsules are tested as
per proper applicable standards.
• Gelatin and Purified water (USP) are tested for their pharmaceutical
grade; other raw materials are tested as per respective specified tests
in United States, British pharmacopeia & other international
pharmacopeias.
CONT......
• Then Gel preparation unit for the preparation of a gel of specific
parameters.
• Color formulation unit to prepare the appropriate capsule color that
fulfills clients demand.
• Capsule production unit where the proper capsule size is made
through proper dipping pin bars for the cap and body,drying units,
cutting units and assembly of final capsule is made.
 IN PROCESS UNIT
• What we were observed from this unit was parameters like
temperature, humidity and viscosity are continuously monitored
&controlled to have weight and moisture contents of capsules within
specified limits.
• All the machines are fitted with vibrator sorting attachments, which
automatically remove loose and mini cap/body production.
• the samples are drawn periodically during the production so as
monitor length, weight, wall thickness,
CONT.....
• dome thickness, shoulder thickness and moisture content of the
capsules.
• in the machine room, the capsules are subjected to visual quality
checks periodically for critical, major and minor defects (details about
these defect are included later in the manual).
• On noticing any defects at any level of quality checks especially at the
machine room, corrective action is taken immediately.
VISUAL INSPECTIONS( sorting) unit

• Then we saw initial sorting room in this room Capsules are visually
inspected on translucent glass on sorting machines.
• This stage removes physical defects such as variation in color, shade,
bubbles, pinholes, bad cuts, loose caps and bodies, oversize in length,
telescopic dents and any other faults.
• the good capsules from sorting department may be sent for printing
depending on customer's requirement.
• The printed capsules are again sent for sorting to remove printing
defects.
 Capsule printing unit
• In this unit we observed both print and non-print empty hard gelatin
capsules .
• Capsules can be printed with product identification information
provided by the customer.
• The printing can be done by linear (straight) printing, circular (spiral)
printing & rectified spin printing (circular printing with orientation)
methods on state-of-the-art high speed printing machines.
• The customer has a choice to choose from the different printing
colors. Printing inks used for printing are food grade.
 Quality control laboratory unit
• At the end of our observation we observed quality control laboratory
unit.
• At the laboratory the end products microbiological, physical and
chemical parameters are done by taking a sample.
• The physical parameters like the cap length, body length, thickness,
outside diameter and weight are checked.
 SUMMARY
• Sino-Ethiop Associate Africa PLC (SEAA) was established in March
2001 with a partnership of two Chinese Companies (China Associate
Group & Dandong JINWAN Group) and
• an Ethiopian Company, ZAF Pharmaceuticals PLC to develop and
market EMPTY HARD GELATIN CAPSULES.
• this PLC produce only empty hard gelatin capsules both printed and
non-printed.
• Currently this PLC produce capsules size of 0, 1, & 2 with various caps
& body colors and different locking facilities.
•10Q
 STUDENTS NAME
• Name ID
• 1 Naol kene RU1513/12
• 2 Jebessa Hirpa RU2130/12
• 3 Dugasa Dejene RU1765/12
• 4 Mulugeta Hailu RU1927/12
• 5 Netsanet Fikadu RU1447/12
• 6 Misgana Amanuel RU0584/12
• 7 Haymanot Ayele RU0506/12
• 8 Bekele Taddege RU0080/12
• 9 Abdi Bedasa RU1085/11
• 10 Marwan Abdurehman RU0580/12
• 11 Rakeb Belachew RU1118/12
• 12. Zekarias Genoto RU 0799/12