Genvio Pharma Limited is one of the pioneers in oncology product manufacturing company in Dhaka, Bangladesh. It’s a specialty pharmaceutical company producing oncology products.
The word GENVIO comes from the Spanish word, “Genio,” meaning genius and the Spanish word, “Vio,” meaning comprehend, understand or visualize. As a leading oncology pharmaceutical company, Genvio Pharma Limited takes pride in being a specialty company. Understanding the technicality of the industry GENVIO is teaming up Genius through research and entrepreneurs of leadership who can visualize to be counted globally. Genvio believes that quality, safety, and effectiveness must be designed and built into the product adhering QbD (Quality by Design) principle.
We as Genvio Pharma Ltd. are one of the fastest growing pharmaceutical company in Bangladesh with state-of-the-art manufacturing facilities designed, built and operated with strict adherence to the current Good Manufacturing Practice (cGMP) to meet and exceed international standards.
We are committed to improving patients QoL (Quality of Life) and ensuring all our medicines meet the highest quality standards and to supply quality medicines to the patients reliably and quickly.
Our dedicated OEB-4 production unit having a total of 96000 sq. ft. Area which is monitored with BMS/computer controlled HVAC system to maintain designated class A, B, C & D according to the requirement of the specific area where the pressure, temperature and humidity are controlled to comply stringent International Standard. To go through highest standard of safety and possible zero contamination, Genvio’s Manufacturing Units is equipped with room dedicated AHU, different kind of filters, restricted access and personnel safety control through PPE (Personnel Protective Equipment’s) like 3M coveralls and hoods, PAPR (Powered Air Purifying Respirators) or supplied air, proper gloves selection, chemical suits when needed by person for using solvents/reagents.
All the process equipment starting from dispensing to storage in depot is done within a controlled system to ensure possible zero contamination.
Quality Management Systems (QMS) Highlights:
Quality Management Systems at Genvio would necessarily cover the concept of a quality control/assurance unit, which is responsible for overall quality management systems. The quality control unit is primarily responsible for documentation (procedures, SOPs, policies, etc.) and control of all documents that impact of our products and peoples quality & safety.
It is meant to facilitate compliance with GxP regulations (DGDA, FDA, MHRA, EMA,) and standards (ISO, European Union GMP). For Genvio, a quality management systems definition encompasses the following quality processes:
Document Control: We have well established Documents management system for control of quality documents related with Good Manufacturing Operations. We also have Training management system for the employees to make them efficient to perform their work.
CAPA Management: Corrective and Preventive Action management is essential to any QMS definition. We streamline and effectively manage the CAPA process. We follow best-practice forms and workflows to guide every step of a CAPA implementation.
Training Control: Genvio Training calendar and employee training curriculum, distribution and monitoring of training tasks and evaluation/grading of tests. Effective training is a necessary component of a compliant company’s quality management systems. On completion of the training the work authorization is granted to the employees.