TEXT BOOK OF PHARMACEUTICAL QUALITY ASSURANCE (English, Paperback, Mrs. Dhruti Mehta)

Quality assurance in the pharmaceutical industry encompasses rigorous standards and processes aimed at ensuring the safety, efficacy, and reliability of medicinal products. It involves implementing quality control measures, adhering to Good Manufacturing Practices (GMP), and embracing Total Quality Management (TQM) philosophies to foster continuous improvement. Regulatory guidelines, such as those outlined by the International Conference on Harmonization (ICH), play a pivotal role in standardizing practices and ensuring global alignment in quality standards. Moreover, initiatives like Quality by Design (QbD) emphasize proactive approaches to product development, emphasizing risk management and optimization throughout the manufacturing process. Adherence to international standards like ISO 9000 and ISO 14000, along with accreditation processes such as NABL, further solidify the commitment to quality excellence and regulatory compliance across all facets of pharmaceutical operations.