Pharma Solutions by Dr. Ajay

  ABSTRACT The objective of this article is to study how technology is transferred in pharmaceutical industry. The article attempts to discuss about the technology transfer process, importance of technology transfer, goals of technology transfer, robust technology transfer by QBD approach, steps involved in technology transfer in the pharmaceutical industry and understand the aspects related with technology transfer. Keywords: technology transfer, pharmaceutical industry, goals, robust transfer by QBD, steps involved. INTRODUCTION [1] A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred. Technology transfer (TT) is defined as “the transfer of the manufacturing process for a new pharmaceutical Drug Substance (DS) and Drug Product (DP)

Rapid mixer granulator is also known as high shear mixer are especially designed to achieve quality mixing and excellent granules at low costs and higher productive too. In pharmaceutical industry rapid mixer granulator plays vital role to mix the ingredients and make granules before compression . Rapid mixer granulators (RMG) are primarily used for tablet manufacturing process which requires homogenous mixing, controlled granule size and at the same time assuring great reduction in processing time. Parts of RMG: RMG having different parts like Impeller, Chopper, Discharge port, Pneumatic system, and control panel etc…. Impeller, Chopper are mainly responsible for wet granulation. Impeller: At the bottom of the dome shaped stainless steel bowl Impellers are fixed with two half-length blades and two full length blades. Impeller is designed in such a way that full length blades push the material and half-length blade lift the material. Impeller helps to break the wet mass into small pie

Recently new materials termed as “super disintegrants” have been developed to improve the disintegration processes. Super disintegrants are another version of super-absorbing materials with tailor-made swelling properties. The prevalent use of Superdisintegrants in orally and fast integrating tablets along with the adoption of new drug delivery system technologies are some other factors propelling the market growth. It shows the superdisintegrants market growth from 2014 to the forecast period 2025. The inclusion of the right super disintegrant is a prerequisite to get optimal bioavailability in tablets and capsules which need rapid disintegration. Super disintegrants are used to improve the efficacy of solid dosage forms. This is achieved by decreasing the disintegration time which in turn enhances the drug dissolution rate. Factors such as growing generic drugs market, geriatric and paediatric population who have difficulty in swallowing tablet/capsules and development of new su

The quality of a product does not occur on its own. People throughout an organization do not always carry out instructions or perform their role correctly. It is the continuing task of quality management to deal with this situation and ensure that all members of the industrial team are aware of their quality responsibilities and are accountable for their actions. Quality must be designed into products– discipline, attitude and inventiveness must be encouraged to create easy to make and easy to use fool proof products. Quality must then be planned into manufacture – methods must be devised so that the easiest way to do the job is the right one; so that, where appropriate, worker interest is created; and elsewhere complete control is built into the process. Finally, quality must be built into the product– the people concerned with the cutting, fitting and assembling must be well trained and enthusiastically led to achieve “right first time” production. This is the simple overall formula,