Report of Industrial Visit To Kopran Pha

REPORT ON INDUSTRIAL VISIT TO KOPRAN PHARMACEUTICALS.
KHOPOLI.
13TH FEB, 2013.
An industrial visit was arranged by Bharati Vidyapeeth’s College of Pharmacy, Navi Mumbai
for T.Y.B.Pharm students at Kopran Pharmaceuticals, accompanied by three professors- Dr. S.
P. Patankar, Mr. Abhay Shirode, and Dr. (Mrs.) Aruna Jadhav.
At 1.05 pm, the students reached the destination and were soon accommodated in the conference
room. We were briefed by Mr. Siddhesh (General Manager), Mr.Wakharia (Senior Manager-
Quality Control), and Mr. D.L.Waghmare (Associate General Manager) about the history of
Kopran Pharmaceuticals. Further he gave an overview of the production line carried out as two
different plants: PENICILLIN and NON-PENICILLIN. Penicillin, being a potent
hypersensitive drug, the production had to be carried out with separate set of precautions. In both
the plants, tablets, capsules, dry syrups were exclusively formulated.
At 1:30 pm, the students were asked to divide themselves in two groups viz. those visiting
penicillin unit and non penicillin unit depending upon their sensitivity to penicillin. Two senior
experts were escorted to each group as guides. The non penicillin group was accompanied also
by Mr. A. R. Shirode. The manufacture of following formulations was seen.
Formulations of the company:

1: Fluconazole capsule 150mg - Koflucon(capsule)
2: Sildenafil tablet 100mg - Nyte 100(tablets)
3: Diclofenac sodium tablets 50mg - Difisal(tablets)
4: Atenolol- Cardioten-25(tablets)
5: Amlodipine besilate tablet 50mg- Klodip 5
The students were provided with separate pair of head cap, foot cover, and apron. They were
briefed regarding the use of hand gloves and masks while in the vicinity of the APIs.
The tour of the industry started soon and the following areas were covered. Information
pertaining to various areas was given in detail.
1) Material in warehouse :
This area was air locked and highly restricted.
The raw materials required for manufacturing i.e. API and excipients were received here.
For e.g. sugar for dry syrups, lactose as a diluent for tablets, magnesium stearate and talc.
2) Quarantine: APIs and excipients are stored in separate racks and labelled.
3) QC Testing:
All the material received is labelled as follows (material is tested by QC department
before it can be deemed suitable for use)
YELLOW Under test

GREEN Approved.
RED Rejected
4) Storage Department:
Segregation of approved APIs and excipients was carried out and material was dispensed
as required to the production unit. AC stores hard gelatin empty capsules for different
drugs (25°C). Adjacent to the storage area, there was BSR (Bonded Store Release) area
where finished goods were moved through a connecting corridor.
5) Material issue:
Man and material entry was through different points i.e. A PASS BOX
It also had a reverse laminar air flow (RLF) for the entire dispensing activity. The
following three people were allowed i.e. the dispensing person, a store person and a
person from the production department.
The manufacturing date and expiry date are stamped on the product in this area before
dispensing.
To avoid contamination, fresh air was let in but there was no outflow of air. This was
achieved by maintaining high pressure inside than the pressure outside using magnihelic
pressure gauge.
6) Production: It comprised of the following processing steps:
a) Sifting
b) Dispensing
c) Blending
d) Capsule filling
e) Tablet Compression
For In-process quality control, intermittent checking of quality right from procurement to
production is done by Quality Assurance.
The SOP’s of the above processes based on dosage form were as follows:
A) CAPSULES:
The blending was carried out using a Turbo sifter. The material was sifted through
several sieves stacked over one another. In process container (IPC containing the API and
the excipients) blending operation performed in a Cage Blender with a capacity of 550
litres. The operation is monitored with the help of a control panel.
Operation time: 20 minutes

Then unloading was performed. (Not manually loaded)
Capsule filling machine room-Dosator type- AUGER FILLING MACHINE 90
TAMPING (AF90T)
Capacity-90,000 capsules per hr. Also AF 40 / AF 80 machines are used.
B) TABLETS (direct compression):
a) Dry blending step

Material was passed through mesh 1-1.5
Oversized material was crushed and passed again through the mesh using Turbo sifter
b) IPC bins (1000 kg) were used to discard fines and dust particles.
c) Pre mixing step was carried out using double cone blending (capacity of 65/ 85/ 35
litres)
d) Compression machine room:
It was a 45 station CMB CADMAC machine.
TOOLING- DB, BB, D & B tooling
D tooling for caplet.
7) Final product QC testing:

Weight variation
Disintegration
Friability
Hardness
8) Packaging: There were 3 levels of packaging viz Human Handlers, Selection, Packaging
and Dispatch. The basic aim is to provide highest quality care.
a) Primary
b) Secondary (blister packaging is done)
c) Tertiary
The Scorpio Rotating Machine was used to fill the drug into the PRP pouches (Patient
Ready Pack)
9) After packaging, PRPs and Blister Leak Test was carried out.
10) QC was governed by QA which decides GMP, SOP with safety and FDA rules and
regulations
a) HPLC
b) Total organic carbon (TOC) – to test hardness of water used (Pure and Ultrapure).
For purified water hardness- NMT 1 ppm
c) Accelerated stability control chamber- products were subjected to exaggerated
conditions of temperature, humidity - degradation pattern was observed - was used to
determine shelf life under normal conditions of transport and storage.
d) Microbiological evaluation: Extent of microbial contamination was estimated using
different techniques like Petri plate method.
Last but not the least, while in the changing room, the guide Mr. D.L.Waghmare
enlightened us about the importance of the outfit to be worn in the plant and its disposal.
Further he added that for a pharmacist, being a healthcare provider, there are no
shortcuts.
The two groups were made to reassemble with their respective guides, after which
refreshments were provided . Doubt solving and brain storming discussions were done.
Mr. Wakharia furnished various career options after a basic graduation course. Lastly, on
a friendly note, they encouraged us to excel in our pharmacy career and that we were free
to approach them for the same.

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REPORT ON INDUSTRIAL VISIT TO KOPRAN PHARMACEUTICALS.

13TH FEB, 2013.

Formulations of the company:

YELLOW Under test

6) Production: It comprised of the following processing steps:

Operation time: 20 minutes

a) Dry blending step

7) Final product QC testing:

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