2024年5月15日 · The SISPQ fulfill the requirements of “Good manufacturing practice (GMP)” set by the various regulatory agencies all over the world.

CGMP “includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, …

SISPQ. Safety, Identity, strength, purity and quality. Anyone working in the business knows that the firm must meet SISPQ as an expectation of quality and that meeting the current Good …

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes...

SISQP是Safety Integrity Strength Quality Purity五个英文单词缩写而来的简称，代表制药行业追求提升质量的目标。 SISQP/plus EQM (企业质量管理系统) 是由洛施德生命科学的资深cGMP咨 …

Throughout the development and release of a product, a critical part of CMC is to establish the safety, identity, strength, quality and purity (SISPQ) of your biologic.

安全性、特性、强度、纯度和质量（sispq） 在商业产品的研发和放行过程中，化学、生产和控制（CMC）的一个关键部分是确立生物制剂的安全性、标识、强度、质量和纯度。

2024年12月15日 · These are the key requirements of SISPQ in pharmaceutical industry to execute during product development and manufacturing. By meeting these requirements, …

SISQP-TMS (Training Management System，以下也称”系统”) 是运用信息化管理手段对中国GMP(2010年修订)、美国FDA cGMP以及欧盟EMEA GMP中规定的重要的GMP培训管理流程 …

The pharmaceutical industry is always guided by GMP to ensure SISPQ elements at all levels of manufacturing. Human error, which began in other industries and prompted a focus on safety …