Monday, July 29, 2013

IN PLANT BEX P-IV


In-plant training report on the basis of observation
In
Beximco pharmaceuticals limited

SUBMITTED TO:

Brig. Gen. Md. MehboobulHaque(Retd.)
GM, HR & Admin (Factory)



SUBMITTED BY:

Md. Ashraful Islam
SharminAkhter
AurpitaShaha
Md. Imran NurManik
(University of Rajshahi)

Md. ShahedulAlamMozumder
TanzinaAkter
(Stamford University)


Date of Submission:  2nd May, 2013


2nd May, 2013

To,
Brig. Gen.Md. MehboobulHaque(Retd.)
GM, HR and Admin (Factory)
BeximcoPharmaceuticals Ltd.
126, Kathaldia, Nishatnagar, Tongi -1711
Gazipur, Bangladesh.


Subject: Submission of In-plant Training Report


Dear Sir,

We, the four students from Rajshahi University and two students from Stamford University have successfully accomplished our in-plant training program. Based on our observation, we have prepared a repot which is a summary of those activities performed by BPL. We are very much thankful to you for giving us an opportunity to perform in-plant training from 17th April 2013 to 30thApril 2013in your Pharmaceutical Plant (Track-I). We are also grateful to all of your colleagues and staffs for support and co-operation during our training program.

We will be highly encouraged if you are kind enough to receive this report and hope it will meet your expectation.


Thanking you,

Sincerely yours,

Md. Ashraful Islam
SharminAkhter
AurpitaShaha
Md. Imran NurManik

(University of Rajshahi)

Md. ShahedulAlamMozumder
TanzinaAkter

(Stamford University)


Acknowledgement


All the praise goes to Allah, the most gracious and wise. Thanks to Almighty Allah for His favor as we have completed our in plant training inBeximco Pharmaceuticals Limited.

Practical training is an integral part of pharmacy education for the students of professional courses because what we learn from textbooks is not sufficient to apply our knowledge in the practical sector.In this case, the in plant training for the students of pharmacy in pharmaceutical industries is absolutely essential for the fulfillment of academic knowledge.


We are thankful to Beximco Pharmaceuticals Limited authority specially to Brig. Gen. Mr. Md.MehboobulHaque(Retd.), GM, HR & Admin (Factory) and Mr.LutfurRahman, Director, Manufacturing and all other Officers and members of Beximco groupfor their co-operation and valuable guidelines.We wish to express our deepest sense of gratitude and sincere thanks to Mr. Arif Md. ToufiqurRahman, Officer, HRA, who was the main coordinator of our training program specially for his friendly and affectionate behavior.

We are extremely indebted to Mr. AnimeshBhowmik(Senior Assistant Manager, Production Planning), Mr. EzazRasool(Manager, Warehouse), Mr. Md. AshrafulAlam (Manager, Solid Dosage Formulation), Mr. Subodh Chandra Das (GM, Research and Development), Mr. Md. AkterHossain (Deputy Manager, Liquid Dosage Formulation), Mr. Md. SazzadHossain (DM, Quality Control Department), Mr. SalimHossain(Senior Manager,Quality Assurance Department)
, Ms. SoomnaLohani(Senior Manager) and Mr. Abdul MannanMiah (Manager,Infusions Unit: Large Volume Potential Formulations), Mr. Yusuf Hossain(DGM, Engineering Services & Utilities), Ms. Saima Sultana (Manager, Training Department), Mr. ZakirHossain(Deputy Manager, EHS) for their valuable instructions and information.


The feeling during training was really excellent and we enjoyed it. Our achievement during this training will definitely help us in our professional field. Thanks to Beximco for their every friendly co-operation.

We wish the prosperous future of Beximco Pharmaceuticals Ltd.



Executive Summary


Beximco Pharmaceuticals Ltd (BPL) is a leading manufacturer of pharmaceutical formulations in Bangladesh. The company is one of the largest exporter of pharmaceuticals in the country and its state-of-the-art manufacturing facilities are certified by global regulatory bodies of Australia, European Union, Gulf nations, Brazil, among others. The company is consistently building upon its portfolio and currently producing more than 500 products in different dosage forms covering broader therapeutic categories.

With decades of contract manufacturing experience with global MNCs, skilled manpower and proven formulation capabilities, the company has been building a visible and growing presence across the continents offering high quality generics at the most affordable cost.

Beximco Pharmaceuticals Ltd (BPL) is a well-established pharmaceutical industry because of maintaining quality first. Beximco pharma follows GMP and cGMP in every single step of production as well as validated SOP. Well-equipped R&D, highly organized QA and QC, sophisticated infusion unit, HRA with skilled employee are the unique features of Beximco Pharma.










 



Introduction


Beximco Pharmaceuticals Ltd is one of the well renowned manufacturers of pharmaceutical productsand Active Pharmaceutical Ingredients (APIs)in Bangladesh and also in the global area. The company is one of the largest exporters of pharmaceutical formulations in the country.  The vision of this pharmaceutical company is to be recognized as a world class pharmaceutical company by providing high standard quality products and services.

During the in-plant training, the process of manufacturing and maintaining quality according to “Good Manufacturing Practice” (GMP) guidelines were observed and in this context, standard operations procedures (SOP) were developed. As a result of visiting in such a reputed and well organized company like BPL, my theoretical concept regarding various issues has developed due to the practical view.

The company is consistently building upon its portfolio and currently producing more than 400 products in different dosage forms covering broader therapeutic categories which include antibiotics, antihypertensive, ant diabetics, anti-retroviral, anti-asthma inhalers etc. The state-of-the-art manufacturing facilities are certified by global regulatory bodies of Australia, Gulf nations, Brazil, among others.

Beximco pharma maintains GMP and cGMP in every single step of production as well as validated SOP. Well-equipped R & D, highly organized QA and QC, sophisticated infusion unit, HRA with skilled employee are the unique features of Beximco Pharma.Maintaining quality first is the main target in production.That’s why Beximco Pharmaceuticals Ltd (BPL) is a well-established and one of the most popular pharmaceutical industries.

According to the schedule, we visited every section ofBPL.Beximco Pharmaceuticals Ltd always manufactures high quality products of various dosage forms and never compromises in the name of quality. We started our in plant training from 17th April 2013 and finished on 30th April 2013.


In plant training program


Training schedule:

Date
Location
Time
Contact Person
April 17’ 2013

Human Resources Department
08.30 am to 11.00 am
Mr. Md. MehboobulHaque
Production Planning
12.00 pm to 12.30 pm
Mr. AnimeshBhowmik
Warehouse
02.00 pm to 05.00pm
Mr. EzazRasool
April 18-22’ 2013
Solid Dosage Formulation
08.30 pm to 05.00 pm
Mr. Md. AshrafulAlam.
April 23’ 2013
Research and Development
08.30 pm to 05.00 pm
Mr. Subodh Chandra Das
April 24’ 2013
Liquid Dosage Formulation
08.30 pm to 05.00 pm
Mr. Md. AkterHossain
April 25’ 2013
Quality Control Department
08.30 pm to 05.00 pm

Mr.  Md. SazzadHossain

Mr. SalimHossain
April 28’ 2013
Quality Assurance Department
08.30 pm to 05.00 pm
April 29’ 2013
Infusions Unit: Large Volume Potential Formulations
08.30 pm to 05.00 pm
Ms. SoomnaLohani

Mr. Abdul MannanMiah
April 30’ 2013
Engineering Services & Utilities
08.30 am to 12.00 pm
Mr. Yusuf Hossain
Training Department
12.00 pm to 12.30 pm
Ms. Saima Sultana
EHS
12.30 pm to 1.00 pm
Mr. ZakirHossain
May 02’ 2013
Report Submission
11.00 am to 1.00 pm
GM, HR & Admin (Factory)
Findings and Analysis

Being a top class and one of the leading pharmaceutical manufacturers of the country, we found following feature during observation.
  • Beximco Pharmaceutical has got the TGA approval of Australia.

  • Advanced and high performance machineries are available.

  • Beximco Pharmaceutical strictly follows the rules and regulations of “Good Manufacturing Practice” (GMP) and “current Good Manufacturing Practice” (cGMP).

  • Research and Development department is self-sufficient for the development of new products but there is no practice of introducing new drug.

  • Lock and key system:  Poisonous and addiction producing drugs like CNS depressants are locked in a chamber.

  • R and D department is only involved in the modification of the existing products.

  • A separated sampling booth is available in warehouse where temperature, humidity and pressure are controlled.

  • Rejected materials are separated quickly to reduce the possibility of mix-up.

  • Beximco Pharmaceutical has a separate training department.

  • Quality control department is well equipped and new machine installing.

  • Hazardous wastes are incinerated safely by the help of ICDDRB.

  • Ensure the environment safety and maintain cleanliness and washing strictly.

  • Production and packaging area machineries follow advanced technology.


But following points need to be noted for the complete GMP regulations.

  • Central warehouse of Beximco pharmaceutical is very large but the location is not well arranged.

  • Spacing problem in compression unit. New machines should be installed for getting more output.

  • LCO department lacks sufficient space and building facilities are not GMP standard.
Recommendation

It is true that Beximco Pharmaceutical Ltd. never compromises regarding quality of products. BPL strictly complies with the every aspect to “Good Manufacturing Practice” (GMP) and “current Good Manufacturing Practice” (cGMP)and maintain in process quality of a product consistently. Moreover, personnel directly or indirectly involved in manufacturing have made GMP as a culture in job responsibility. Though it is too much tough to find out any suggestion for further modification, some recommendations are pointed below

  • Dispensing area of the Solid department should be airtight.

  • Principles followed for the products that are exported in foreign countries, should also be followed for local or domestic products

  • Environmental facilities and GMP regulations in TRACK-I should be increased.

  • MDI plant should be revealed to the trainee.

  • There should be an audio visual round system for the trainee before starting their action.

  • Central warehouse of Beximco pharmaceutical is very large but the location is not well arranged.

  • LCO department lacks sufficient space and building facilities are not GMP standard. That’s why it is urgent to shift the department or to upgrade the facilities

  • Spacing problem in compression unit. So, space should be wider than present.

  • New machines should be installed for getting more output.

  • Emphasis should be given in newer drug formulations.











  Conclusion

Beximco Pharmaceutical Limited is one of the leading pharmaceutical industries in Bangladesh. Its contribution for the development of national economy is well known. Beximco Pharmaceuticals Ltd. has a pioneering role in exporting pharmaceuticals from Bangladesh. Nevertheless it has provided a large number of manpower and also promoting the talents in the field of pharmaceuticals.
We are very much delighted as we have come in contact with the Beximco family during my In- plant training with them and we are also very much impressed by their generosity.





                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
                                                                                                                                                                                                                                                                                                                                                                                     



Bibliography

1. Personnel ofBeximco Pharmaceuticals Ltd.
2. Batch manufacturing Record (BMR)
3. Batch Packaging Record (BPR)
4. Material Release Data sheet.
6. www.beximco.com/
7. www.ru.ac.bd/phar/atrupharm.htm
8. Various websites for information about Beximco Pharma Ltd.

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