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