31
In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali 1 Introductio

SQUARE Pharmaceuticals Limited

Embed Size (px)

Citation preview

Page 1: SQUARE Pharmaceuticals Limited

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

1

Introduction

Page 2: SQUARE Pharmaceuticals Limited

In plant training for the professionals is now essential to know in details the

application mode of modern scientific and management issue aiming to familiar

them correctly.

This training is the bridge between the theories and principles with their

practices, in other words between the institution and commercial organization.

SQUARE Pharmaceuticals Limited is committed to ensure between lives through

quality medicine. For this, we selected the SQUARE Pharmaceuticals Limited to

be trained which is already known as one of the tops leading pharmaceutical

company is Bangladesh. I fell proud to take my training in such factory.

All of the employees from top to the bottom of the factory are very much

cooperative and responsive, they help us to understand every operation, simplify

various critical points and make me understand a factory job. we are very much

grateful and our cordial gratitude to them.

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

2

Page 3: SQUARE Pharmaceuticals Limited

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

3

Company

Page 4: SQUARE Pharmaceuticals Limited

Company over view

SQUARE Pharmaceuticals Limited is the largest pharmaceutical company in

Bangladesh and it has been continuously in the 1st position among all national

and multinational companies since 1985. It was established in 1958 and

converted into a public limited company in 1991. The sales turnover of SPL was

more than Taka 5 Billion (US$ 90 million) with about 15% market share (April

2003 – March 2004) having a growth rate of about 16%.

SQUARE today symbolizes a name - a state of mind. But its journey to the growth

and prosperity has been no bed of roses. From the inception in 1958, it has today

burgeoned into one of the top line conglomerates in Bangladesh.

SQUARE Pharmaceuticals Limited, the flagship company, is holding the strong

leadership position in the pharmaceutical industry of Bangladesh since 1985 and

is now on its way to becoming a high performance global player.

Milestones :

1958 : Debut of Square Pharma as a Partnership Firm

1964: Converted into a Private Limited Company

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

4

Page 5: SQUARE Pharmaceuticals Limited

1974: Technical Collaboration with Janssen Pharmaceutical, Belgium, a

subsidiary of Johnson and Johnson International, USA.

1982: Licensing Agreement signed with F. Hoffmann-La Roche Ltd., Switzerland.

1985: Achieved first position in the Pharmaceutical Market of Bangladesh among

all national and multinational companies.

1987: Pioneer in pharmaceutical export from Bangladesh

1991: Converted in to a Public Limited Company

1994: Initial Public Offering of Square Pharmaceutical Shares

1995: Chemical Division of Square Pharmaceuticals Ltd. starts production of

pharmaceutical bulk products (API).

1997: Won the National Export trophy for exporting pharmaceuticals.

1998: Agro-chemicals & Veterinary Products Division of Square Pharma starts

its operation.

2001: US FDA/UK MCA standard new Pharmaceutical factory goes into

operation built under the supervision of Bovis Lend Lease, UK.

2004: Signing of agreement with ROVIPHARM, Vietnam to manufacture and

market SQUARE products under license in Vietnam.

Secured the top position for the best published accounts and report for 2003 in

the manufacturing category for transparency and excellence in corporate

reporting.

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

5

Page 6: SQUARE Pharmaceuticals Limited

2005: New State-of- the-Art SQUARE Cephalosporin Ltd. goes into operation;

built under the supervision of TELSTAR S.A. of Spain as per US FDA/ UK MHRA

requirements.

Their Mission

Their mission is to provide quality & innovative healthcare relief for people,

maintain stringently ethical standard in business operation also ensuring benefit

to the shareholders and other stakeholders.

Their Vision

They see business as a means to the wellbeing of the investors, employees and

the society at large, leading to accretion of wealth through financial and moral

gains as a part of the process of the human civilization.

Their Objective

Their objectives are to conduct transparent business operations within the legal &

social frame work with aims to attain the mission reflected by our vision.

Strengths of SQUARE Pharmaceuticals Ltd

- Strong leadership

- House keeping

- Traditional safety culture

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

6

Page 7: SQUARE Pharmaceuticals Limited

- Good discipline

- Occupational health

Export

Present Markets

Asia: Bhutan, Cambodia, Macau, Malaysia, Myanmar, Nepal, Iraq, Papua New

Guinea, Sri Lanka, Tajikistan, Uzbekistan, Vietnam, Yemen

Africa: Botswana, Benin, Comoros Islands, Gambia, Ghana, Kenya, Libya,

Mauritius, Mozambique, Malawi, Niger, Rwanda, Sierra Leone, Somalia,

Tanzania

Europe: Kosovo, Ukraine

Markets under Exploration

Asia: Hong Kong, Iran, Laos, Maldives, Philippines, Qatar, Saudi Arabia,

Thailand, UAE

Africa: Algeria, Chad, Nigeria, South Africa, Sudan, Ethiopia

Europe: England, Russia

America: Costa Rica

Major Therapeutic Areas

Their marketed product portfolio covers seven core therapeutic areas

Alimentary Preparations

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

7

Page 8: SQUARE Pharmaceuticals Limited

Antiallergy Preparations

Antidiabetic Preparations

Antiparasite Preparations

Bone Calcium Regulator

Cardiovascular Preparations

CNS Preparations

Drugs for Urinary Incontinence

Eye and Ear Preparations

Haematinics

Lipid Modifying Preparations

Local Anesthetics

Mineral Supplements

NSAIDs and Antigout Preparations

Penicillins and Cephalosporins

Quinolone Antibiotics

Respiratory Tract Preparations

Systemic Antifungal, Antiviral and Antiprotozoal Agents

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

8

Page 9: SQUARE Pharmaceuticals Limited

Thyroid Therapy

Topical Preparations

Vitamins and Minerals

Dhaka Unit

The Dhaka Unit is about 50 km away in the north of the capital city. Bovis Lend

Lease, UK designed this plant. This is a state of the art manufacturing facility for

oral solid dosage forms and all facilities have been developed meeting the

requirements of cGMP CFR 21. Dhaka Unit started its operation at the end of

2002.

In the year 2002, the representative of UNICEF, Copenhagen, audited Dhaka

Unit facility and enlisted this plant for their global supply. Besides UNICEF audit,

in 2003, David Begg Associates, an UK based consulting company also audited

this facility and recognized that this plant fulfills the requirement of MHRA (United

Kingdom Medicines and Healthcare Products Regulatory Agency).

Objectives of Dhaka Unit

Meet challenges of globalization

Expand export horizon

Attract contract/ license manufacturing

Benchmark for pharmaceutical industry in Bangladesh

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

9

Page 10: SQUARE Pharmaceuticals Limited

Dhaka Unit is endowed with the following unique features

1. General Production building

Raw material receiving bay with electrocutors to prevent entering insects

Two air conditioned warehouses one is for raw materials and another is

for finished goods and packaging components

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

10

Page 11: SQUARE Pharmaceuticals Limited

Electronic controlled (Interlocked) double-door air locks for material entry

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

11

Page 12: SQUARE Pharmaceuticals Limited

Complete dress change through double change rooms have been

implemented for the personnel with mandatory shower at the first time

entry in a day

All production equipments are modern state of the art from European and

American sources and are cGMP compliance

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

12

Page 13: SQUARE Pharmaceuticals Limited

Down flow sampling and dispensing booths

Granulation suites are completely closed with vacuum loading and transfer

facilities

Material handling is performed by Intermediate Bulk Container (IBC)

system-a closed system for efficient and safe handling of bulk materials

(powder/granules).

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

13

Page 14: SQUARE Pharmaceuticals Limited

IBC cage for powder/granules blending with safety interlock barrier.

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

14

Page 15: SQUARE Pharmaceuticals Limited

IBCs are cleaned through PLC control cleaning cycles with hot, cold and

purified water for effective cleaning

Materials (powder/granules) are discharged by gravity fed discharge

station which is a closed system

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

15

Page 16: SQUARE Pharmaceuticals Limited

2. Secured reject store independent from production building

3. QC laboratory

Independent from production building

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

16

Page 17: SQUARE Pharmaceuticals Limited

All equipments (HPLC, GLC, FTIR, FTNIR, Infrared spectrophotometer,

Atomic absorption etc) are state of the art and from Japanese, European

and American sources.

All

stability studies are performed as per ICH storage guidelines

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

17

Page 19: SQUARE Pharmaceuticals Limited

5. Building Energy Management Systems (BEMS) to control and monitor

temperature, relative humidity and air pressure differential at the

processing area.

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

19

Page 20: SQUARE Pharmaceuticals Limited

6. Central Dust Collector to achieve dust free operation at the point of dust

generation in the processing area

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

20

Page 21: SQUARE Pharmaceuticals Limited

7. Own generation of electricity to ensure uninterrupted power supply

round the clock

8. Purified water meets USP 27 specification. After a series of pretreatment

and softening, softened water is passed through de-ionizer and reverse

osmosis for final purification. Auto sanitization system also exist in the

purified water distribution system.

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

21

Page 22: SQUARE Pharmaceuticals Limited

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

22

Page 23: SQUARE Pharmaceuticals Limited

9. Central and in-house laundry for factory garment cleaning

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

23

Page 24: SQUARE Pharmaceuticals Limited

In-plant Training at Square Pharmaceuticals Ltd – Syed Shazzad Ali

24

Orientation And

Department of Square