Recent Trends, Opportunities and Challenges in 3D Printing Technology for Personalize Medicine

The scrutiny of medical devices industry as well as pharmaceutical industry for its application in health care industry on different platform is captured the 3D printing technique.  3D printing technology withstand for a very long duration only because of the approval of medical devices, 3D printed tablets and also with the advent of USFDA guideline on technical consideration. This technology is specific to devices utilizing preservative manufacturing. Many thoughts are triggered by 3D printing this technology and for successful delivery of intended product which is necessarily take into a consideration. In this review paper expectation limitations of some regulatory companies, Advantages, disadvantages, what type problems are arises while establishing this setups for drug product production, method, application, and manufacturing risk are represented. It also gives information about the current status of 3D printing technology in research and development of drug products.  For the fabrication of novel solid dosage form a number of 3D printing technology have been developed. This review is mainly focused on describing different technology used for the application of 3D printing in pharmaceutical industry.  Keywords: - 3D printing technology, recent trend, Opportunities, personalize medicine, challenges, future

A Review on Life Cycle Management Approach on Asset Qualification

All equipment’s used in the production of products shall be properly Validated, Qualified and Calibrated to demonstrate that it is suitable for its intended purpose. Qualification is an important aspect of the pharmaceutical quality system. When the equipment is properly qualified, verified and maintained, there is the possibility of Consistent performance of the equipment. A well designed qualification program saves valuable time and cost. Qualification is called a cyclic process because it is a never ending process. Appropriate documentation of the qualification program is very important as lack of the documented evidence does not give any meaning to qualification (Not documented it means not done).  The current programs and procedures of equipment qualification used within any pharmaceutical and bioscience industry are based on ‘regulatory requirements’, ‘voluntary standards’, ‘vendor practices’, and ‘industry practices’. The output is considerable variation in the way any pharmaceutical and biotechnological companies approach for the laboratory equipment. The lifecycle management approach of equipment qualification covers entire life cycle for the specification, design, manufacturing, installation, commissioning, qualification (4Qs Model DQ, IQ, OQ, PQ), operation & maintenance of equipment in a risk based life cycle management approach. The goal of any regulated pharmaceutical and bioscience company is to provide reliable and valid data suitable for its intended purpose. Main goal of equipment qualification is to form the basis for written procedures for production and process control which are designed to assure that the drug products have the SISPQ (Safety, Identity, Strength, Purity and Quality) Keywords: Validation, Calibration, Life cycle management approach, Qualification (4Qs Model- DQ, IQ, OQ & PQ), SISPQ (Safety, Identity, Strength, Purity and Quality

Biosensors: An Emerging Technology in Pharmaceutical Industry

The evolution of biosensors has been the center of scientist's attraction for recent decades. It is a device which is used mainly for living organism or different biological molecules, enzymes or antibodies, to find out the presence of chemicals. Biosensors can basically serve as low-cost and highly efficient devices in addition to use in other day to day applications. Biosensor is a device that consists of two main parts: A bio-receptor and a transducer were as, Bio-receptor is a biological component that recognizes the target analytes and transducer is a physicochemical detector component that converts the recognition event into a measurable signal and quantify or it transforms one signal into another one, this works in a physiochemical way like Optical piezoelectric, electrochemical etc. Biomolecules like antibodies, enzymes, organelles, receptors and microorganisms as well as animal and plant cells or tissues have been used as biological sensing elements. In this paper, we review recent development and use of biosensors as a diagnostic tool, as well as some future applications of biosensor technology. Keywords: Biosensors, Microbial biosensor, Transducer, Pathogen detection

A Review on Quality by Design Approach (QBD) for Pharmaceuticals

Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. The foundation of Quality by Design is ICH Guidelines. Keywords: QbD design, ICH, QTPP, CQA, PAT