错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Strategic Association for Quality Excellence: Coordination Between GMP, GLP, GCP, Metrology, QC, and QA

  • B. K. Rana,
  • Deepshikha Yadav,
  • Sanjay Yadav

摘要

The good manufacturing practices (GMP), good laboratory practices (GLP), good clinical practices (GCP), metrology, quality control (QC), and quality assurance (QA) are essential quality system frameworks and used in manufacturing and regulated environments, such as the drugs and pharmaceuticals, life science, and healthcare sectors. These quality frameworks collectively play a fundamental role in ensuring the safety, efficacy, and reliability of products and research within the life sciences. These standard practices, measurement, and quality system elements are intertwined, reinforcing one another to maintain the highest standards of safety, efficacy, and ethics throughout the life sciences. This integrated approach emphasizes the critical role of accurate measurements, calibration, quality control, and adherence to strict regulatory standards. The commitment to excellence and adaptability to evolving technologies and regulations underscore the significance of this synergy in safeguarding public health, ensuring data integrity, and driving progress in the pursuit of high-quality products. Although all these disciples are vastly explored and used independently, no serious efforts are made to investigate the interaction and synergy among them wherever applicable. Authors have attempted to discuss the possibility of such interactions. The present chapter explores first the essentiality of these elements individually and then later elaborate the intricate web of interactions and dependencies between these practices and fields.