NAME CARD
- First name: NUR AINAA BINTI MOHD FAUZI
- Faculty: Malaysia-Japan International Institute of Tech.
- Student ID: A19MJ0233
- Email address: nurainaa@graduate.utm.my
- Country: Malaysia
NUR AINAA BINTI MOHD FAUZI's wall
Internship Training at Duopharma Manufacturing (Bangi) Sdn. Bhd Reflection
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Company’s name : Duopharma Manufacturing (Bangi) Sdn. Bhd
Company’s address : Lot No. 2,4,6,8 & 10, Jalan P/7, Seksyen 13, Kawasan Perusahaan Bandar Baru Bangi, 43650, Bandar Baru Bangi, Selangor
Department : Quality Assurance Department
Duration : 25th July 2022 – 14th Oct 2022
Company’s supervisor : Puan Siti Nur Zullaini Abd Wahab
MJIIT’s supervisor : Assoc. Prof. Dr. Roshafima Rasit Ali
Company’s principal activity : Pharmaceutical manufacturing
For my internship training, I was assigned to the Quality Assurance department. The QA department is responsible for maintaining standard requirements and enhancing product quality. Besides that, it focuses on improving work processes and efficiency to ensure the high quality of the development process and its results. My scope of work is learning the working flow of the Quality Assurance Department and assist the QA team with daily tasks. My major QA department trainings include batch manufacturing record training, product quality review, product complaint, and BMR monitoring.
At the end of the internship, I gained a fresh perspective on Quality Assurance. Despite the fact that my placement was not the same as my course, I was introduced to new skills in a different sector. In addition, I learn how to communicate and connect with my team, as well as how to uphold professional ethical standards in the workplace.
I was conducted BMR monitoring began on September 1st and continued more than a month. The goal is to examine and seek for ways to improve the waiting time at each level. The corresponding department will suggest a solution based on the results of BMR monitoring to guarantee that the product is made on time and that the time it takes to reach the consumer is as short as feasible.
I assisted the QA executive in preparing the investigation report while dealing with product complaints (PC). Along with other departments, I serve as QA representatives on the Product Complaints Investigation Team (PCIT). I also assist in examining all pertinent data and documents in accordance with committee members' choices and sending it to the appropriate individuals. The investigation report includes root cause analysis, corrective action and preventive action taken, and any additional material needed to validate the complaint.
I also preparing Product Quality Review (PQR) for product Promedyl Plus Linctus and Salmax CR 4mg. Each of the products produced by Duopharma Biotech Berhad must undergo PQR and it is to be done annually. The purpose of PQR is to check the consistency of the existing process, the suitability of current requirements for both starting materials and finished product, and to identify any trends for product and process improvement identification.
The QA department exposed me to BMR preparation at the start of my internship. BMR includes the formulation, raw materials utilized, packing instructions, labelling, In-Process Quality Control (IPQC), Good Manufacturing Practice (GMP) checklist, quality control finished product, and others. After the product has finished manufacturing, the BMR is already filled with information from the Production department. The BMR is reviewed and validated by the Quality Control department before that specific batch is released for distribution.