Quality Control for GMP Manufacturing
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.
QA / QC Release Testing
Adhering to regulations and guidelines for pharmaceutical production and quality control doesn’t have to be a headache. Instruments from Beckman Coulter Life Sciences are designed to create data and export original electronic records securely in parallel with quality control measurements.
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.
Good Manufacturing Procedure (GMP) mandates the air quality conditions for biopharmaceutical production in cleanrooms
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).