INDUSTRIAL TRAINING REPORT
FACULTY OF
BIOTECHNOLOGY AND BIOMOLECULAR SCIENCES
NAME
: Alia Nur Alissa Binti Mohamad Hatta
MATRIC NUMBER
: 190120
PROGRAMME
: Bachelor of Science (Hons.) Microbiology
NAME OF ORGANIZATION
: Duopharma (Manufacturing) Bangi Sdn. Bhd
INDUSTRIAL SUPERVISOR
: Puan Nur Salma Redzuan
VISITING LECTURER
: Dr. Fairolniza Mohd Shariff
TRAINING PERIOD
: 10th February 2020 – 21st July 2020
INDUSTRIAL SUPERVISOR
:
SIGNATURE
LECTURER’S REMARKS
:
Description of the industry
Figure 1.1 Duopharma Manufacturing (Bangi) Sdn. Bhd
Duopharma Biotech Group (“Duopharma Biotech” or “the Company”) began with the
establishment of Duopharma (M) Sendirian Berhad in 1979. Duopharma Biotech was
incorporated in 2000 and is today one of Malaysia’s leading pharmaceutical companies listed
on the Main Market of Bursa Malaysia Berhad. Duopharma Biotech has core competencies in
the pharmaceutical industry inclusive of Manufacturing, Research & Development and
Commercialisation & Marketing of over 300 generic drugs such as Omesec and Prelica as well
as Consumer Healthcare (“CHC”) products including CHAMPS®, FLAVETTES®,
PROVITON® and Uphamol, which are well-recognised and accepted by consumers in
Malaysia, regionally and globally. The Company has also diversified into the biosimilars space
with technology and commercialisation collaborations with credible and strong international
partners. Headquartered in Kuala Lumpur, Malaysia, Duopharma Biotech owns and operates
three manufacturing plants in Klang, Bangi and Glenmarie, Selangor. Duopharma Biotech also
has subsidiary companies in the Philippines and Singapore. A subsidiary of Duopharma
Biotech Berhad has a representative office in Jakarta, Indonesia.
Duopharma’s Brand:
Vision: Providing Smarter Solutions for a Healthier Life
Mission: Leading Healthcare Group Providing Quality and Innovative Solutions
Tagline: Smarter Solutions, Healthier Life
Duopharma’s Core Values- PETIRR:
P-Passion
: Inspire and energise everyone to be the best
E-Excellence : Consistently deliver outstanding performance through innovative solutions
T-Teamwork : Succeed together because we work as one
I-Integrity
: Conduct ourselves with pride in being honest and ethical
R-Responsible : Honour the trust given to us by being accountable for our actions
R-Respect
: Value differences and sincere intentions as the basis for achieving shared
aspirations
History of Company
Figure 1.2 Duopharma Biotech Sdn. Bhd. Logo
In 2005, Chemical Company of Malaysia Berhad (“CCMB”) acquired Duopharma, a
pharmaceutical company that was established since 1979. In 2006, Duopharma was rebranded
to CCM Duopharma Biotech (“CCMD”). In 2007, CCMD acquired the assets and brands of
Malayan Pharma. In 2015, CCMB underwent a corporate restructuring. All of its
pharmaceutical subsidiaries were placed under CCMD. On 28 December 2017, CCM
Duopharma de-merged from CCMB. Therefore, CCMD became an independent public listed
company. On 25 February 2019, CCMD has changed its name to Duopharma Biotech Berhad
(“Duopharma Biotech”). Duopharma Logo is rendered in bold red, the colour of passion. D
and B stand for ‘Duopharma’ and ‘Biotech. The shape of logo is modern, symbolises
innovation across every aspect of the business and has six sides represent the company’s six
core values (PETIRR). Name of Duopharma at the bottom is expressed in a font that perfectly
balances rounded shapes. “Duo” represents the company’s two main businesses; prescribed
medicine and consumer healthcare product.
Change of Name of Company:
Details of the Management Structure
The organizational chart is divided into two categories, Board of Directors and Board of
committees. Duopharma Biotech have a few branches for Production, Research and
development, pharmacy and also sales and marketing in Malaysia and few other countries as
shown in the Corporate Structure.
Figure 1.3 Board and Corporate Structure of Duopharma
Research and Product Produced from the Industry
Duopharma Innovation Sdn Bhd (“DISB”) is the Division’s dedicated in-house pharmaceutical
R&D facility, centred independently at Glenmarie, Selangor. DISB is a state-of-the-art R&D
centre accredited with the MS ISO/IEC 17025 standard. The centre also houses lab scale
equipment for formulation trials, designed towards GMP requirements. DISB provides
scientific and technical knowledge and skill in the development of high quality, safe and
efficacious pharmaceutical products. DISB has a pilot batch facility, which is essential during
a product’s development and optimisation phase.
Duopharma Innovation Sdn Bhd’s four divisions:
Duopharma’s Facilities’ and Products:
Duopharma’s New Products Pipeline:
Project Updates- HAPI Plant:
Pilot batch for Letrozole 2.5mg tab (1st product)
• Successfully conducted Comparative Dissolution Profile “CDP” (against Natco’s batch) with
good result.
• Passed all acceptance criteria for 1st month stability study.
•Target to conduct Process Validation (PV) batches in Q2 2019.
Other progress
• NPRA inspection target by end of April 2019.
• Collaboration with UTM in waste water deactivation management.
Summary of Industrial Training
Knowledge that I have gain in this pharmaceutical company is vast and there is still a lot to
learn. I was assigned to Quality Control Department (QC). QC Department perform chemical
and physical testing on substances either raw materials or finished products to ensure the
substances tested meet their specifications and to conduct testing of products with proper
etiquette and integrity to ensure the released products are of the optimum quality. In QC
department I have experienced assisting tasks related to Microbiology Lab, Finished Good,
Raw Material, Good Laboratory Practices (GLP) as well as filing and documentation. In any
scenario, the work requirement must be recognized to do the work effectively and sensibly.
Completing a task without the required understanding, abilities and expertise will lead to errors
and work and outcomes of reduced performance.
Pharmaceutical Microbiology Testing:
a) Microbiological Analysis of Water
To ensure that the purified water produced meet the required specification and the water system
remains in a state of good control. Media used are R2A agar (Quantitative analysis), Cetrimide
(CETA) & MacConkey (MCA) agar which are Qualitative analysis. CETA & MCA are
Selective media where MCA favors growth of Escherichia coli (E. coli); CETA favors growth
of Pseudomonas aeruginosa (P. aeruginosa). E. coli changes color to purple violet if it is
present; P. aeruginosa changes to fluorescent green. Cellulose nitrate filter is used during
testing. Sodium Thiosulfate neutralizes chlorine in water during sampling. One tablet of
Sodium Thiosulfate can neutralize 100mL of water.
b) Environmental Monitoring (EM)
For proper monitoring and control of the Microbiology laboratory environment to monitor
baseline contamination levels after renovation / shut down. It is being carried out at Production
site using air sampler for active sampling. Each plates are being left for 5 minutes to absorb air
from the surrounding whereas settle plates are used for passive monitoring. The plates are left
not more than 4 hours as microorganisms only pass by the plates. Two types of media which
are Trypticase Soy Agar (TSA) which detects any kind of bacteria and Sabouraud Dextrose
Agar with Chloramphenicol (SDAC) which detects other microorganisms except for bacteria.
Bacteria grows at 30°C to 35°C whereas fungi at 20°C to 25°C for 7 days.
c) Microbial Contamination Test (MCT)
To test non sterile finished products and raw material for enumeration of viable microorganism
present (bioburden level) and the absence of specific pathogens and also to test on stability of
sample such as expiry date and temperature as well as validation such as Standard Operating
Procedure (SOP). Microbial Enumeration Tests are used for determination of Total Aerobic
Microbial Count (TAMC) and Total Combined Yeast / Moulds Count (TYMC) as well as
Plate-count method (Pour-plate Method) which is applicable to samples which do not cause
opacity to the agar medium. Plate-count methods are performed at least in duplicate for each
medium and the mean count of the result is used.
d) BBL Crystal Identification Systems
To identify the type of microorganisms, whether its Gram positive or Gram negative. Single
colony was isolated from plates grown with microorganisms. Single colony is then inoculated
into inoculum for enteric bacteria and Gram positive bacteria. Inoculum is poured into well of
BBL Crystal. Oxidase test and Indole test are done for Gram negative or enteric bacteria.
Bactident oxidase for the oxidase test. A blue to blue-violet colour developed after approximate
20 to 60 sec if the result is positive and there will be no changes if the result is negative.
Trypticase soy broth (TSB) and Indole reagent are used for Indole test. The appearance of red
ring at the surface of the broth within 30 seconds indicates a positive reaction for indole
production. Meanwhile, a yellow colour indicates a negative reaction.
e) Quality Control Tasks
Besides doing Microbiological testing, I had experience in assisting many other tasks such as
joining internal training conducted by executives in QC department, prepared different types
of media for Microbiological testing, did transfer streaking for growth on MCT plates, prepared
Isopropyl alcohol, scanned Certificate of Analysis (COA) for product release before sending
them to Quality Assurance department, did assay on product summary, built graph for trend
analysis, created a masterlist for In-process QC products, did filing and documentation
especially for National Pharmaceutical Regulatory Agency (NPRA) audit preparation, did
physical chemical testing such as measuring density and viscosity of liquid products, calibrate
pH meter, helped to prepare for microbiological assay, translated Standard Operating
Procedures, checked retain samples, update log book for products received and media usage,
updated Post Market Surveillance from other pharmacies, update data logger for temperature
monitoring checklist, updated instrument calibration and verification schedule and many more.
Critical Evaluation of the Industry
In my opinion, Duopharma is a well-established company which is very efficient in carrying
out their analysis for all the products that they produce as well as their great management skills.
Duopharma has its own strategies to diversify onto high-value biologicals and niche products,
expand their range of Ethical and Consumer Healthcare (CHC) product portfolios, enhance our
presence in the ASEAN region and upgrade of manufacturing facilities into world-class assets.
The challenges that this company face are Insulin tender (3 + 2) ending in 2019, engage with
Ministry of Health to opt for 2 years extension, APPL expiring by 31 December 2019, reduction
in consumption, increasing cGMP requirements, short term revolving credit from OCBC,
differences in regional regulations impacting growth of international businesses, expanding
product portfolios (prohibitive BE and clinical costs) and strengthening USD resulting in
higher cost of imported raw materials whereas the opportunities that this company have
experienced are commercialization of high value product in niche therapeutic areas such as
oncology and bio-therapeutics, registration of Erysaa, an erythropoietin (EPO) biosimilar,
which has been approved by National Pharmacy Regulatory Agency (NPRA) on 31st January
2019, able to bid for government tender worth RM 10 –15 million, registration of Trastuzumab,
an oncology product has been approved, oncology facility to commence in Q3 2019,
implementation of National B40 Protection Scheme and growing International Business
segment.
Conclusion
In conclusion, my internship experience has been an incredible adventure with the
assistance of my supervisor, Puan Salma and my colleagues as I had the option to effortlessly
adjust to the workplace. Working in an organization has supported me into being a
progressively dependable, fair and straightforward in order for me to gain exposures. Being
mindful is important to everybody in guaranteeing that their task is to be finished on schedule.
I am grateful that I have been in heaps of occasions while in UPM as it has helped me in
working up my confidence, and sustains my abilities, which I had the option to utilize them
during my internship. I believe that, for me to be familiar outside my comfort zone, I should
be valiant enough to accept on any challenges and dangers that in comes my way.
As per stated, the theories that I have learned in UPM has helped me a great deal in
guaranteeing that I am consistently on a similar page as to those around me during work. I have
met different amazing individuals from different department who are expert on what they are
doing whereby their theoretical information are vast which has been motivating me in wanting
to gain more knowledge that I have as for now. Although I am not of the equivalent level of
knowledge as them, they have been welcoming and urging for me to uncover myself and adapt
new things outside of my area of expertise. They spent a lot of time teaching me new things
that I would not learn in UPM. Realizing their job scopes, working environment and theoretical
information have widen my understanding on the diverse job the staffs are capable of. I believe
that in any case of where we originate from, the bond between the individuals is significant
enough to build trust among one another.
To wrap things up, my sentiment on my internship experience is that having the option
to experience such workplace like Duopharma has been the best piece of experience. In spite
of the fact that various individuals may encounter diverse circumstances, we would consistently
need to look things from the positive side as it will consistently turn into a lesson to be learnt.
Building connections is an advantage for me as it will help me not just during my internship
period but in the future as well.
Appendices
Figure 1.4 Water Sampling at Production area and Water Testing in Micro lab for
Microbiological Analysis of Water
Figure 1.5 Air sampling at Production area using MiniCapt Mobile Microbial Air Sampler for
active sampling; settle plates for passive monitoring and colony count for growth on plates
after 5 days of incubation using colony counter.
Figure 1.6 Finish Good products and Raw Material samples to be tested for MCT, MCT Media
used for testing and weighing balance used to weigh the amount of products needed to be
inserted into media.
Figure 1.7 BBL Crystal Enteric/NF Panel lid, a BBL Crystal base; Stool ID Inoculum Fluid &
BBL Crystal Light Box/Panel Viewer
Figure 1.8 Color reaction chart for Enteric & Gram Positive bacteria
Figure 1.9 Several examples of Quality Control tasks which I have completed apart from doing
testing, especially filing and documentation