The product Development (PD) department is an important wing of The IBN SINA Pharmaceutical Industry PLC which is enriched with a number of highly qualified and experienced personnel.
The goal of the PD Department of The IBN SINA Pharmaceutical Industry PLC is to develop innovative, high-quality pharmaceutical products in a cost-effective way maintaining its highly ethical issues regarding human health.
Our experienced PD team is dedicated to developing & introducing quality products according to ICH guidelines followed by QbD approach and continuous improvement of new and existing products for customer satisfaction, environmental change, technology change and other competitors. The inter-department liaison of PD with SMD, QA, QC, Purchase & Production helps a successful introduction of a new product to valued customers.
PD Department is equipped with highly sophisticated machineries and equipments of GMP standards for the development of new products in an efficient manner.
PD team ensures the following activity:
Preformulation study - to check bio-chemical action and incompatibility of ingredients.
Comparative Dissolution Study with Innovator Products - In-vitro dissolution testing is the identifying need for bioequivalence studies which is done followed by RLD/ Innovator product.
Process Development and Validation - The development of manufacturing processes by which the product can be consistently reproduced on a commercial scale.
Pharmaceutical Formulation - the formulation of molecules into a Pharmaceutical dosage form (e.g. Tablet, Capsule and Injectables, etc.)
Pharmaceutical Analysis - the development of analytical methods to characterize the Active Pharmaceutical Ingredient including its chemical and physical properties, stability and the presence of impurities
Pharmaceutical Maintenance - improvements or changes in manufacturing processes, formulation, or analytical methods
Stability Study - following ICH guidelines, physical, chemical, and microbiological aspects of the formulation are checked and determined the shelf-life of product.
Preparation of Sample and Documents - Preparation of samples, protocols and other documents for registration of products from DGDA. Preparation of BMR for all products manufactured following cGMP requirements.
Scale-up/Pilot batch manufacturing - A fully furnished scale-up manufacturing facility is developed with modern machineries where PD team ensure optimization of critical process parameters by manufacturing scale-up/pilot batches for smooth commercial manufacturing.
Technology Transfer - After completion of successful development and process validation of a new product, Formulation & Manufacturing instruction, Product specification & Analytical method are then transferred to Production and Quality control for commercial manufacturing.
PD yields a good number of quality products in the health sector every year. This active participation of The IBN SINA Pharmaceutical Industry PLC in the pharmaceutical sector stands as one of the leading pharmaceutical industries in Bangladesh.