PRODUCT DEVELOPMENT

The creation of products with new or different characteristics that offer new or additional benefits to the customer. Product development may involve modification of an existing product or its presentation, or formulation of an entirely new product that satisfies a newly defined customer want or market niche. The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls. Information from pharmaceutical development studies can be a basis for quality risk management. It is important to recognize that quality cannot be tested into products, i.e., quality should be built in by design. Changes in formulation and manufacturing processes during development and lifecycle management should be looked upon as opportunities to gain additional knowledge and further support establishment of the design space. The Pharmaceutical Development describe the knowledge that establishes that the type of dosage form selected and the formulation proposed are suitable for the intended use. At a minimum, those aspects of drug substances, excipients, container closure systems, and manufacturing processes that are critical to product quality should be determined and control strategies justified. Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can have impact on the quality of the drug product. Containers and closures The testing is done on the product in immediate containers and closures proposed for marketing. The packaging materials include aluminium strip packs, blister packs, Alu-Alu

packs, HDPE bottles etc. This may also include secondary packs, but not shippers. Products in all different types of containers/closures, whether meant for distribution or for physician and promotional samples, are to be tested separately. However, for bulk containers, testing in prototype containers is allowed, if it simulates the actual packaging is required.

Orientation of storage of containers Samples of the solutions, dispersed systems and semi solid drug products for stability studies must be kept upright and positioned either inverted or on the side to allow for full interaction of the product with the containerclosure. This orientation helps to determine whether the contact between the drug product or solvent and the closure results in the extraction of chemical substances from the closure components or adsorption of product components in to the container-closure.