Cipla Visit

DATE:- 7TH OCTOBER 2006

Objectives of visit

 To get introduced to the environment of the

pharmaceutical manufacturing plants
 To know about the different departments of the
plant
 To know about current good manufacturing
practices (cGMP)
 To know about work culture being maintained
by cipla
 Chemical,industrial and
pharmaceutical laboratories
Since 1935
Founded by one of the great
visionaries of modern India
DR. Khwaja Abdul Hamied
His legacy was carried forward by his son

Dr.Yusuf K. Hamied
Present Chairman and
Managing Director
In Tandem With

Amar Lulla
Joint Managing Director
Cipla – A success story

 Cipla was established by Dr.Khwaja Abdul Hameed in 1935 with a

capital of 6 lakh rupees.
 Now, cipla has 31 manufacturing facilities and over 4 R&D centres.
 Cipla has manufacturing plants at Goa, Baddi, Bangalore, Patalganga
and Vikhroli
 Cipla sales stood at above 3000 crore in financial year 2005-06 and had a
net profit of around 600 crore rupees.
 Cipla in the year ending 31 march 2006 exported products worth 1500
crore rupees.
 The cipla manufacturing units has been accredited by all major global
regulatory authorities.
 Some of the major products of cipla are asthalin , atorlip, entofoam,
melflam, etc.
 Triomune and Duovir-N are the innovative treatment kits which reduced
‘pill burden’ and cost for patients on retroviral therapy . These kits are
available in over 130 countries
.
Patalganga Plant
Plant profile

 Patalganga industrial area is situated on the left bank of river Patalganga,

which is 10 km from Mumbai-Pune National Highway 4 and 7 km from the
Mumbai-Pune expressway. It is just 12 km from Mumbai-Goa national
highway 17
 Plant was established in 1982,the fourth major factory just outside Mumbai.
 It is approved by USFDA, MCC (South Africa), MCA( UK), TGA
(Australia) and SICD (Slovakia)
 The facility has 3 API plants and 1 formulation tablets and ointments plant)
 Around 250 employees work in the plant
 The plant follows standard operating procedures(SOP’s) strictly.
Division of work

 In any pharmaceutical manufacturing plant.

There are 4 departments:-
a. Administration
b. Quality control (QC)
c. Quality Assurance (QA)
d. Production
API facilities
• There are three API plants.
 cGMP is followed srictly.
 All the reaction vessels were made of high grade steel and there was inner
glass coating in some vessels.
 There is no scope of exposure of bulk drug.
 In process transfer takes place through pipes connecting the reaction vessels.
 Different pipes are represented by different colors for demarcation.
 In house water treatment plant consists of a deionizer, UV treatment and 0.2
µm pore filter.
 It controls and keeps a constant check on over 20 parameters.
 Proper safety measures are followed.
 Proper documentation is done and maintained.
Formulation plant

 The plant manufactures tablets and ointments.

 The whole building has apoxy flooring.
 All the doors and stacks are made of stainless steel as according to
cGMP no wood material is allowed in manufacturing area.
 The whole manufacturing and storage areas have air handling units
(AHU’s).
 At each entry there is a double door air locking system.
 Even the packing material and storage area is under heating
ventilation and air conditioning (HVAC).
 The whole storage area data is computerized.
 There are separate areas for storage of primary ,secondary and
tertiary packing materials.
 There are dispensing booths( for primary packing material also)
TYPICAL STEPS FOR HANDLING OF
MATERIALS FROM THE SUPPLIER TO
DISPENSARY
 Supplier
 Delivery
 Quarantine (under test)
 Accept/Reject
 Collation
 Transfer
 Computer Operation
 Transfer to storage area
 Production Demand/indent
 Computer Operation
 Transfer
 Dispense
Tablet Manufacturing
•
• Tablets are the most common dosage form as it is convenient for
the consumer and easy to produce for manufacturer
• The components of a tablet are:-

i. Active Pharmaceutical Ingredient (API)

ii. Diluent
iii. Binder
iv. Lubricants and Glidants
v. Disintegrants
vi. Colouring agents
vii. Flavoring agents
PROCUREMENT OF RAWMATERIAL FROM MANUFACTURERS &
AUTHORISED DISTRIBUTORS
↓
TESTING OF RAW MATERIAL
↓
WEIGHING OF RAW MATERIAL IN RAW MATERAIL STORE
CHECKING OF WEIGHMENTS IN TABLET SECTION
↓
SIFTING OF ALL RAW MATERIALS
↓
MIXING OF RAW MATERIAL AS PER MASTER FORMUALE
↓
PREPARATION OF PASTE
↓
GRANULATION
↓
DRYING OF GRANULES
INPROCESS TESTING OF GRANULES
↓
COMPRESSION INTO TABLETS
↓
COATING OF TABLETS IF REQUIRED
↓
FINAL TESTING AND CLEARANCE BY QC LABORATORY
↓
INITIAL PACKAGING IN BLISTERS STRIP OR ALUMINIUM FOIL
STRIP
↓
INTERMEDIATE PACKAGING INTO CARTONS
↓
FINAL PACKAGING INTO SHIPPERS
↓
DISPATCH
 Mass Mixer Multi Mill

Fluid Bed Dryer (FBD)

Rapid mixer granulator (RMG)
Some highlights

 We got to see the manufacturing

of the new product Viraday, it is
a combination of three retroviral
drugs (Efavirenz 600 mg,
Tenofovir 300 mg and
Emtricitabine 200 mg), which
can be taken just once a day.
 The automatic packing of tablet
strip into small cartons was quite
impressive.
 Any
Questions

? ?
Thank You