The cGMPs as codified by 21 CFR 210 and 211 (and others as applicable) are the minimum requirements necessary to demonstrate that the drug products meet SISPQ. After all, it is impossible to test 100% of the drug products – if we did there would not be any medicines available for use.

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, materials...

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.

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

(a) The regulations set forth in this part and in parts 211, 225, and 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to saf...

Safety, Identity, Strength, Purity and Quality (SISPQ) Throughout the development and release of a commercial product, a critical part of Chemistry, Manufacturing and Controls (CMC) is to establish the safety, identity, strength, quality and purity of your biologic.

Adherence to regulatory guidelines and an established quality management system safeguards the SISPQ elements of the industry. The pharmaceutical industry is always guided by GMP to ensure SISPQ elements at all levels of manufacturing.