Researches for and development of new products
Usually, the primary function of the R&D department is to conduct researches for new products and develop new solutions. Each product has a finite commercial life. In order to be competitive, the company continuously needs finding ways for new technological development of product range. When researching and developing new products, both the R&D managers and their staff take responsibility of performing the following key tasks:
Ensuring the new product meets the product specification
Researching the product according to allocated budget
Checking if the product meets production costs
Delivering products in time and in full range
Developing the product to comply with regulatory requirements and specified quality levels
the design of new product must consider the following
1 – Scaling up and reproducibility of manufacturing steps of the formulas to be manufactured in the production area according to GMP by the available machine and ensure that the scaling up dose not affect the quality, stability, efficacy of the dosage form.
2- Method of analysis: the formulas executed must be suitable for analysis by our available instruments and the method of analysis must be sensitive ,rapid and valid to analyze the recovery % (assay) ,dissolution, , comparative dissolution .impurities, degradation product (stability indicating method ) used in stability studies.
3- Confirming to guidelines of stability protocols according to ICH, WHO, internal regulation (MOH) for the dosage form in different packing materials stored in accelerated & long conditions to ensure the stability &efficacy of the formulas during the predicted shelf life in its packing materials.
4 – Designing the Batch Manufacturing Process: for critical steps according the requirement of GMP and the performed validation process.ش