World-Class Facilities & Quality Assurance
Production
In order to meet the growing challenges of medical science, stringent regulatory requirement of both local and international market and post TRIPS agreement GPL has established its state-of-the-art manufacturing facility at Mymensingh. This plant has been designed by APC, leading consultant of the world keeping focus on the contemporary and upcoming changing therapeutic needs of mankind. This plant reflects our relentless efforts towards continuous improvement and achieving finest quality for our countrymen as well as inhabitants of the world as a whole.
This manufacturing facility has been designed with an aim to comply with the international norms of cGMP and with particular emphasis on meeting standards of the UK MHRA, TGA, WHO, ICH, ISO, PIC/S and other strict regulatory body.
GPL is continuously and strongly promoting to enhance production abilities by realizing quality improvement and low cost manufacturing.
Production facilities have built up the integrated system of Research and Development, Quality, Production and Engineering mainly to fulfill the need of population of Bangladesh and all over the world. By introducing sterile products in addition to others, GPL endeavors to meet the diverse needs of patient and health professionals. GPL has well-reputed experiences in expanding and developing of new products and facilities.
Research & Development (R & D)
Pharmaceuticals Research & Development is challenging venture for local & global market and development of novel drug including biotechnological products. Constantly pumping of new products in market helps the company to survive and build up its image. Personnel of R&D department always try to provide an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process. It is important to recognize that quality cannot be tested into products, but should be built in the product by design. We introduce innovative high quality (efficacy & safe) new product considering cost effective. Our R&D team emphasize on successful in developing & introducing quality products according to ICH guidelines and continuous improvement of new and existing product for customer satisfaction, environmental change, technology change and other competitors.
For that, we have dedicated and trained R&D personnel along with well-equipped separate Galenical and Analytical laboratory with all necessary machineries and equipment’s of GMP standard in small scale
Quality Assurance (Q & A)
Quality is the mainstay of our competitiveness. Our objective is to constantly achieve QUALITY EXCELLENCE. To achieve this, we take considerable focus in adherence to the QA policies. Quality Assurance, though an independent function, works as an interface between R&D and manufacturing strictly abiding with the standardized quality system, providing consistency, effectiveness and efficiency for all manufacturing activities across all our manufacturing locations. An excellent team of professionals having good understanding of concepts of quality systems and cGMP is working to ensure quality assurance at each stage right from receiving of starting materials to finished products to assure the highest international standards.
The major functions covered under the umbrella of quality assurance:
- All validation activities including-
- System validation such as Water system, HVAC system, Compressed air & Nitogen
- Facilities validation such as Room qualification(RQ)
- Machine/Equipment validation (IQ, OQ, PQ)
- Process simulation study for aseptic product (Media fill trial)
- Process validation
- Analytical method validation
- Approval of raw & packaging materials
- Monitoring of manufacturing processes through in-process control
- Approval of finished products & batch release
- Implementation of cGMP
Documentation of technical information including dossier
Quality Control (QC)
• UPLC (Ultra Performance Liquid Chromatography)
• HPLC (High Performance Liquid Chromatography)
• GC (Gas Chromatography)
• TOC (Total Organic Carbon) Analyzer
• Atomic Absorption Spectrophotometer etc.
Focuses on review of failures, rejections, market complaints, deviations, non-compliances, and various corrective & preventive actions, the goal is to reduce quality management system (QMS) more robust and consistent.