In recent years, the idea of “establishing strong systems” has evolved far beyond its original scope. This cGMP principle was initially designed to require pharma manufacturers to handle their own materials testing. Today, “strong systems” includes effective partnerships with your upstream suppliers...
The US Food and Drug Administration (FDA) has yet to weigh in publicly on the new DIS documents. However, the Division of Manufacturing and Product Quality within FDA’s Center for Drug Evaluation and Research (CDER) has released a statement saying, “FDA is supportive of efforts to set sta...
1. “Current Good Manufacturing Practice (CGMP) Regulations,” U.S. Food and Drug Administration, May 19, 2023, https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations 2. “What is a contract research organization (CRO)?,” MED Institute, ...
OOS (Out of Specification) refers to a product that does not meet the established specifications as expected. OOS investigation determines the actual cause of the results.
SOPs are mandatory for the implementation of GCP and other GxPs, namely, cGMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice), within the scope of quality systems; therefore, it is well said that without SOPs there are no GxPs: no SOPs, no quality systems, and no GxPs ...
A man’s body creates nitric oxide in response to sexual stimulation, which activates the enzyme guanylate cyclase to make cyclic guanosine monophosphate (cGMP), a chemical messenger that relaxes the smooth muscles in the penis and boosts blood flow. An erection is the effect of this. ...
21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements ; Final Rule The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final...
What is a Batch? A batch in pharma manufacturing is a specific quantity of a drug product intended to have uniform character and quality within specified limits. It can be produced according to single or multiple production orders during the same cycle of manufacture and is intended to be avail...
COVID-19 is caused by severe acute respiratory syndrome coronavirus -2 (SARS-CoV-2), a name adapted from SARS-CoV that caused the infection of SARS in 2003 [2]. Since none of the explored therapies can directly kill the virus, vaccines have become the last hope to stop the pandemic. ...
The platform now includes more comprehensive candidate screening and bioavailability enhancing tools, ADME considerations, in silico DMPK modeling, materials for cGLP intravenous and oral toxicological studies, and cGMP materials for first-inhuman studies. CONTRACT PHARMA COMPANY SHOWCASE: LEARN MORE ABOUT ...