Pharma, Pharmaceutics and Biotechnology Conference

Drug development is an integrated process that has pharma analysis and quality assurance for the safety and efficacy of pharmaceutical products. Two disciplines include a broad number of analytical techniques and quality control measures for the assessment of quality, purity, and stability of drug products throughout the life cycle. Pharmaceutical analysis is applied to the composition, potency, and purity of drugs. These include chromatography, spectroscopy, and mass spectrometry, which serve as essential tools to identify and quantify APIs and excipients.

For instance, high-performance liquid chromatography is used for differentiation, identification, and quantification of components of a drug preparation, whereas FTIR can also be utilized to determine the chemical composition and purity of raw materials. Quality assurance (QA) in the pharmaceutical industry refers to the processes and practices put in place for products to be manufactured consistently and to the right specifications of regulatory requirements. GMPs ensure production processes, conditions of the facility, and training for staff. The assurance of GMP by pharmaceutical companies minimizes risks associated with drug production, thereby ensuring the produced product is safe, effective, and of high quality. The validation of analytical methods and processes forms an important part of QA.

Method validation would ensure that analytical procedures provide reliable reproducible results so that it develops confidence in data generated during the course of testing. This, in pharmaceutical analysis, includes the examination of the accuracy, precision, specificity, and robustness of methods applied. Regulatory compliance is the other critical aspect of pharmaceutical analysis and quality assurance. Different agencies, such as the FDA, EMA, and ICH, have set up some rules to be followed in the manufacture of pharmaceutical firms' products for public consumption with safety of drugs.

The pharmaceutical industry emphasizes auditing and quality evaluation through regular inspections to ensure that standards are adhered to in the production of the products. It has only reaffirmed the formulation of drugs as complex, especially with biologics and combination therapies. Also increasingly necessary, therefore, is to couple powerful analytical techniques with strong quality assurance. Novel concepts such as real-time release testing (RTRT) and process analytical technology (PAT) are now being applied to enable the live monitoring of the process and, consequently, direct quality assessment at each stage of production.

New developments in pharmaceutical analysis and quality assurance practices shall be presented during the session. These include recent emerging analytical technologies, regulatory challenges, and the critical role quality assurance plays in pharmaceutical safety and efficacy within today's complex healthcare landscape.