[column]An International summit on ‘GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice): USA, Europe, Japan, Asia Pacific’ was held in Philadelphia, USA in December, 2012. A GMP expert from Bangladesh talked about the issues and challenges in the implementation of the GMP and GCP.The audience felt curious as she talked about the limitation of adequate sources & availability of experts, understanding of regulation requirements, increasing attention of regulatory bodies to third world countries, obstacles of GMP and GCP implementation, significance of bioequivalence study. She also emphasized to incorporate the GMP and GCP in developing countries like Bangladesh and how these can be proceeded.
She is Mrs. Masuma Anwar. She was born on May 10, 1974. She completed her SSC from Ahmed Bawany School, Dhaka and HSC from University Laboratory College, Dhaka in 1989 and 1991 respectively. She completed her Bachelor of Pharmacy and Master of Pharmacy from Punjab University, Lahore, Pakistan. She achieved her MBA from North South University in 2002.
She started her career in Libra Infusions Limited as a Senior Quality Assurance Officer. After that she joined Renata Limited as an In-charge of Injection Manufacturing area in August 2004. Her career in Novartis Bangladesh Limited was quite versatile where she served as Product Development Executive, Quality control Manager and Quality Compliance Manager. Now, she is working as the Head of Quality Management System and Project leader of TQP (Total Quality Plan) in Healthcare Pharmaceuticals Limited, Bangladesh.
Mrs. Masuma experienced trainings different sectors in the field of pharmacy. She got trained in management system promotion, hospital pharmacy, industrial pharmacy, total quality management systems. She has also developed her skills on Advance GMP Module-2 and Module-3, Lead Auditor Course ISO 9001:2000. She also participated in comprehensive management development Program, Situational Leadership Workshop (SLW), and M1 Training organized by Novartis Bangladesh Limited.
She believes that her professional mission can only be accomplished by helping the organization to achieve quantum leap in productivity and profitability by sharing, caring and leading its goals and objectives.
Masuma Anwar, one of the GMP experts of the country not only shares her valuable experience but also put forward her opinion about the steps must be taken in order to develop country’s pharmaceutical sector in exportation of drugs:
PharmaMirror: Please tell us about recent advancements of Healthcare Pharmaceuticals Ltd (HPL).
MasumaAnwar: Firstly, Healthcare Pharmaceuticals Limited (HPL) has launched their sterile facility in the year, 2012. Secondly, HPL has appointed Devid R Buckley, the world renowned GMP expert from Australia as their GMP consultant in the year, 2012.
PharmaMirror: What are the functions of Quality Management System (QMS) in pharmaceutical industry settings and how do you think it can to affect product quality?
- Development of overall quality system at site
- Update the quality system as per regular changes in global regulatory requirement
- Ensure total qualification and validation of the facility which takes place as per GAMP5 (Good Automated Manufacturing Practice (GAMP) and
- Compliance the requirement for data integrity
- Audit the whole plant
- Train the people
- Ensure GMP at site
- Prepare SOP (Standard Operating Procedure), Manual and other GMP documents
PharmaMirror: We have come to know that recently you have participated in a conference as an invited speaker in Philadelphia, USA, arranged by OMICS group. Please share your experiences to us.
MasumaAnwar: Basically, I was invited by OMICS to talk on “Current issues and challenges facing to implement GMP and GCP in Europe, USA, Japan and Asia Pacific”. The event was dated from 3rd to 5th December 2012 at Hilton Hotel, Philadelphia. It was a great experience. There were total 50 participants as speaker and most of them were from USA, UK and other developed countries. The forum was very rich and some participants were from FDA regulatory body. The audience paid attention to my presentation and they expressed their curiosity on Pharmaceutical practices in Bangladesh. After closing the session, I received appreciation mail from a couple of participants and some of them were from USA based consultancy firms.[/column]
PharmaMirror: How nation can be benefited by your participation in the above mentioned conference?
MasumaAnwar: I was presenting not only myself; but also Healthcare Pharmaceuticals and I was also highlighting quality of Bangladeshi pharmaceutical products which will definitely give a good impression to the forum about Bangladeshi pharmaceuticals. This will be a help to the company registration, if any company from Bangladesh wants to register their product for US market. However, the organiser of the conference OMICS is a very rich group having members, who are respected and experienced professionals from pharma industries, healthcare sectors, consultancy firms and regulatory bodies.
PharmaMirror: Please describe the essentials of Bioequivalence (BE) Study to export drugs to developed countries or for FDA registration?
MasumaAnwar: Bioequivalence study is not only a regulatory requirement, but it also deals with patients’ safety. For developed and FDA controlled market, it’s a mandatory requirement. Nowadays, few of our local companies are focusing on BE study of their products to get registered in USA, Canada, UK and other restricted market. Unfortunately Bangladesh has no BE study laboratory or CRO (clinical research organization) yet, but soon it will become a mandatory requirement for Bangladesh.
PharmaMirror: Do you think it is possible to setup a BE Study lab in Bangladesh? The readers would be delighted to know more about the importance and feasibility of BE study in Bangladesh.
MasumaAnwar: Yes, It is possible. I think at least the top 20 companies can consider advancements in this area. Any one of the 3 options can be taken into consideration for a successful BE study.
First option: The pharmaceutical companies; especially those have hospitals as well as pharmaceuticals, can do an collaboration with a CRO based on USA, UK or other developed countries and having certification and approval from regulatory bodies.
Second option: Develop or set up an independent CRO, get approval from regulatory bodies and focus at least the Asian countries.
Third option: Joint venture with Governmental institute or lab and develop a CRO in the country with the help of World Health Organization (WHO) because WHO is working with collaboration of FDA, UNICEF and other organizations.
PharmaMirror: What is the commercial purpose to establish a BE study lab in Bangladesh? How much economical do you think we can be by having our own lab initiated?
MasumaAnwar: The cost will reduce up to 50 percent compared to current study toll. If one company does BE study for 10 molecules per year, then cost of two companies for 20 products will be enough to set a BE study lab in Bangladesh.
PharmaMirror: Is there any company (currently operating) doing BE Study in Bangladesh?
MasumaAnwar: Not in a focused way.
PharmaMirror: Please tell us the importance of CRO in Bangladesh settings. What steps can be taken by Government in order to establish the sector?
MasumaAnwar: This is the best time to develop CRO in Bangladesh and the top 10 pharma companies should take initiatives. Bangladeshi pharmaceuticals are growing so fast and if we want to survive in global market, we have to increase export targeting the developed countries. For export, we have to ensure BE study for each export molecule. It will also contribute in other clinical researches related to API manufacturing and clinical trial.
PharmaMirror: Please inspire young generation pharmacist by few sentences.
MasumaAnwar: Keep updating yourself by learning, learning and learning and that will be your life time asset.
PharmaMirror: Pharma Mirror feels pleasure to your time.
MasumaAnwar: Thank you. [end_columns]
[Interviewed by Fahad Hussain, Editor of Pharma Mirror Magazine. Manuscript by Mohsina Mukti, NSU & Shimul Banik, NSTU]