Контроль качества для производств GMP
Quality Control (QC) is required in many critical steps of the GMP Manufacturing process. Raw materials used in the manufacturing of bio/pharmaceuticals must undergo QC prior to inclusion in the process. The entire production process requires a QC standard operating procedure (SOP) to ensure the possibility of contamination is neutralized as much as possible. Lastly, the final product must undergo QC to ensure it meets specifications and quality standards of the original drug manufacturer.
API / Excipient Powder Granule Sizing
Formulations include APIs, excipients (non-active ingredients), such as diluents (an active filler to achieve a reasonable final pill size), and disintegrating agents to regulate the tablet’s dissolution time after administration. These materials need to be sized for consistency.
Bioprocessing / Cell Culture
Within bioprocessing there are two QC processes. One is Production QC where technicians ensure the cells are growing and their media fits within specified ranges for cell growth. The other is Product Efficacy QC, where assays are run to test the efficacy of the drug prior to distribution.
Clean in Place (CIP) Processes
Keeping the bioreactor environment clean is critical so regulators insist that, where possible, bioreactors need to be cleaned in place (CIP) after production.
Final Product Quality Testing
QC for injectables/parenterals is critical because when performing final quality testing for injectable drugs, it’s easy to contaminate samples and produce costly errors in Pass/Fail calculations
Small Molecule Insulin Formulation
The bioavailability of insulin analogs is strongly dependent on not only the primary structure of the analog but also the formulation. Here, AUC can be leveraged as a potential tool to analyze the higher-order structure of insulin under typical formulation conditions.
Water Release Testing for GMP Manufacturing
The quality of the water used in manufacturing is defined by the global Pharmacopoeias who have harmonized the parameters and requirements for Purified Water (PW) and Water for Injection (WFI).