“QUALITY THE UNIT WE COUNT”

ARISTOPHARMA LTD.

Manufacturer of Pharmaceutical Products

IN-PLANT TRAINING REPORT

TRAINING PERIOD

17 th August to 30thAugust, 2015

IN-PLANT TRAINING REPORT

Submitted to:

Mr. Mahmud Hassan

Director

Industrial Operations

ARISTOPHARMA LTD.

Submitted by

Farzana Zaman

Sumiya Nahar

Zinnat Rehana Semu

Avisshek Paul

Department of Pharmacy, State University of Bangladesh

Date:10.08.2015

To

Director, Industrial Operations

ARISTOPHARMA LTD.

Shampur, Kadamtali

Dhaka-1204

Subject: Submission of In-Plant Training Report.

Dear Sir,

We are the students of Department of Pharmacy under State University of Bangladesh.It’s our great pleasure to inform you that we have completed the training report titled as “In Plant Training Program in ARISTOPHARMA LTD.” from 17thAugust 2015 to 30st August 2015. It has been a great experience for us to get ourselves trained in ARISTOPHARMA LTD.

All of us tried our best to prepare a report on our in-plant training program.We hope that you would be kind enough to accept our report and it will be a pleasure for us.

Sincerely Yours,

Farzana Zaman

Sumiya Nahar

Zinnat Rehana Semu

Avishek Paul

Department of Pharmacy, State University of Bangladesh

ACKNOWLEDGEMENT

All praise to Al-mighty Allah who has given us the opportunity to carry out this in-plant training and write up the report. It is our great pleasure and proud privilege to express our gratitude to our parents for their endless love, admiration and encouragement throughout our life.

Firstly, we would like to thank Mr. M. A. Hassan, Chairman and Managing Director, Mr. Mahmud Hassan, Director, Industrial Operations and Tasnuva Mahmud, Director, Product Development, ARISTOPHARMA LTD.,for their kind acceptance to perform 12 days In-Plant Training from 16th March to 31th March, 2015 in ARISTOPHARMA LTD. where we have earned practical knowledge about a pharmaceutical company in different section.

Next, we would like to thank Mr. Nasimul Mahbub, General Manager-Plant; Dr. Md. Shariful Alam, General Manager-Quality Assurance; Mr. Asad Quader Shamsuddin, General Manager-Engineering; Mr. Tushar Kanti Pal, Asst. General Manager-Quality Compliance; Mr. Khandaker Mahbubur Rahman; Sr. Manager-Engineering, Mr. Md. Ahsan Habib, Manager-Production;Mr. Mohammad Mostafa Kamal, Manager-Production; Mr. Mohammad Omar Faruk, Manager-Quality Control; Mr. Mohammad Saber Hossain, Manager-Commercial (Warehouse In-Charge); Mr. Chowdhury Mofirul Islam, Manager-Production (Solid); Mrs. Shaheda Ferdous, Deputy Manager-Quality Compliance; Mr. Md. Wahedur Rahman, Deputy Manager-Administration; Dr. Kohinoor Begum, Deputy Manager-Validation; Mr. Biddyut Kumar Sarkar, Deputy Manager-Production (LCO); Mrs. Abeda Sultana, Deputy Manager-Product Development; Mohammad Omar Faruk, Manager, Quality Control; and Mr. Sujit Chandra Mazumder, Training Officer;for their kind assistance, support and valuable suggestion during our in-plant training period. Their valuable guidance helped us to in enrich our pharmaceuticals knowledge and it will help us for future improvement. It is our pleasure to pay our utmost respect to all managers of the respectivedepartments for their kind co-operation.

We are grateful to all the Sr. Executives, Executives, Senior Officers and Officers for their generosity during our in-plant training period.

We would like to express our heartiest regards and gratitude to all the staffs and personnel of ARISTOPHARMA LTD. for their helpfulness and kind assistancefrom all the way through our trainingprogram. We are greatly indebted to everyone for giving us valuable advises and enlightenment of us about the utility of the company and our future.

Finally, we would like to convey our gratitude to our respected Advisor professor Dr Md. Abdur Rashid & Associate professor Md. Saiful Islam Pathan, Department of pharmacy, State University of Bangladesh for creating the glorious opportunity for us to perform in plant training in ARISTOPHARMA LTD. We would also like to express our gratefulnessto all our faculty member for guiding us throughout our journey.

Purpose of In Plant Training

An essential part of quality education for the students of professional courses is ‘In-plant training’ as theoretical knowledge is seldom sufficient to apply our knowledge in the practical field. Considering this, the industrial training for the students of Pharmacy department in pharmaceutical industries is extremely necessary; here we get an opportunity to correlate our theoretical knowledge with the practical experience.

A pharmaceutical industry not only deals with production of medicines and equivalent materials but there are also many different section that are taking responsible part for the development of such products This training create a bridge between the theoretical and practical practices of pharmaceutical and teach us about them. Through this every students can gain knowledge and experience many things that are new.These experiences are like the seeds that aresowed by in plant training that develops the mind and person to blossom in the future.

Company Profile:

Aristopharma Ltd. is a leading pharmaceutical company in Bangladesh. The company started its journey in 1986 with the honest promise of providing quality medicines at affordable prices to countrymen. Its state-of-the-art manufacturing plant, located at Shampur-Kadamtali I/A, 10 km from central Dhaka, is equipped with highly sophisticated and advanced facilities. The facility is planned and designed to meet the local as well as international demand both qualitatively and quantitatively. Aristopharma manufactures medicines of wide range of therapeutic classes like antiulcerants, antibiotics, NSAIDs, antipyretics, vitamins & minerals, laxatives, cardiovasculars, antidiabetics, steroids, antispasmodics, antihistamines, antipsychotics, antiemetics, antiseptics and many more. It started manufacturing sterile ophthalmic products in 2002 and presently is maintaining no. 1 position in ophthalmic market in Bangladesh. Aristopharma's 2nd plant with 66,000 sq.ft. floor area was built in 2010 beside the existing plant to manufacture hi-tech products like inhalers, lyophilized injections, pre-filled syringes, suppositories, insulin & others bio-tech products. The project work for its 3rd plant as per US FDA/UKMHRA standard is progressing at Gacha, Tongi. The plant once completed would open up export opportunities to USA & European markets. Apart from normal tablet and capsule this plant would help us to manufacture amino acid, hormone, vaccine, anti-cancer products etc.

In Aristopharma, quality is a journey, not a goal. It continuously sets higher standards and feels passionate to achieve all that. The motto of Aristopharma's quality policy is "Quality – the unit we count." The WHO approved current Good Manufacturing Practices (cGMP) & current Good Laboratory Practices (cGLP) are followed in every step of operation.

Aristopharma conducted bioequivalence study for its products like Omep (Omeprazole) Capsule, Metacard MR (Trimetazidine) Tablet, Lodipin-5 (Amlodipine) Tablet, AZ (Azithromycin) Capsule & Suspension, Aropen (Meropenem) Injection etc. The company also conducted clinical trials on Taxetil (Cefpodoxime), Afix (Cefixime), Metacard MR (Trimetazidine), Intravas (Enoxarin), Ipec-Plus (IPC+Folic Acid+Zinc) etc. and the results of these studies showed that they are as effective as innovators' brands. It may be mentioned that clinical trials on some other products are ongoing at different hospitals and universities.

With the aim to cope with the challenges of globalization, Aristopharma ltd. stepped beyond the boundary of Bangladesh in 2000, Vietnam being the first country to export. Today Aristopharma exports it quality medicines to 25 countries of 5 continents and is moving aggressively to expand and extend its export market.

As recognition to its Quality Management System, Aristopharma achieved ISO 9001:2000 certificate in 2005. The certificate was issued by Orion Registrar Inc. USA, one of the prime certification bodies in the world. Later on the certificate was upgraded to ISO 9001:2008 standard.

Today around 4000 employees are relentlessly working for Aristopharma in its journey to build healthier future.

Vision : is to provide better healthcare for the society by manufacturing & marketing quality medicines at affordable price.

Motto: is "Quality- the unit we count". And by quality we never mean only product quality, it extends to our all business activities as well.

Strength:is the support that we have gained from our people, our customers and other stakeholders around us.

Our Quality Policy

In Aristopharma, quality is a journey, not a goal. Hence its efforts to improve quality never ends up. Aristopharma continuously sets higher standards and feels passionate to achieve all that. The motto of Aristopharma's quality policy is "Quality – the unit we count."

The objectives of Aristopharma's quality policy are-

  • To maintain and improve status of an integrated healthcare company through acquisition of state-of-the-art skills and facilities and enhance competency of human resources through appropriate relevant training program.
  • To adhere strictly with WHO cGMP regulations in respect to Manufacturing, Quality Assurance, Marketing and Distribution of medicinal products and to keep compliance of regulatory specifications of local authority.
  • To practice and continually improve "Quality Management System (QMS)" in its totality to consistently meet customers' needs in the global context.
  • To review and upgrade "Quality Audit Program" to match with regulatory requirements.