Remote quality and GMP audit
A Remote quality and GMP audit, also known as a virtual audit, is conducting a GMP audit remotely. The remote audit is conducted using communication and electronic technologies Read More >>>
mRNA-based drugs platforms for cancer treatment
New mRNA-based drugs platforms for cancer treatment The successful development of mRNA (messenger ribonucleic acid) based on anti-COVID 19 vaccines happened in a relatively short time through many Read More >>>
Corrective and preventive action (CAPA) system
Introduction "Nonconformity" investigation is a very common term used in production and product quality improvement areas in the pharmaceutical and medical devices industries. It is mandatory and a Read More >>>
CE Annex 11, FDA 21 CFR Part 11: Computerized systems and software validation
What is software validation? Software validation is part of the computerized systems validation (CSV) process. Computerized systems validation is defined as documented evidence with a high degree of Read More >>>
Good weighing practice (GWP) for laboratory and production balances
Introduction Weighing of raw materials, products, reagents, excipients and other product related materials is an area which has risks in the biotechnology and pharmaceutical industries. Any weighing mistake Read More >>>
Good Storage and Distribution Practice (GSP/GDP), cold chain safety and validation
Background Good Storage Practice (GSP) and Good Distribution Practice (GDP) describe human, veterinary and investigational drug substance and drug product supply chain procedures and standards for assurance of Read More >>>
Stem cell medicinal products cGMP and cGTP
Background The use of stem cells for therapeutic and clinical applications is a fast growing area in Biotech research and development. Stem cells have the potential to differentiate Read More >>>
New drug development and regulation from clinical trials to marketing approval
Background After a new investigational drug pre-clinical stage 1 is completed, and a US IND (Investigational New Drug application) or EU CTA (Clinical Trial Application) submission to the Read More >>>
Surface Treatment for Medical Devices
Surface Treatment for Medical Devices Surface roughness level is a parameter of the surface quality commonly measured as the average deviation of the surface profile from the mean line Read More >>>
New drug development and regulation from pre-clinical to clinical trials
[vc_row][vc_column][vc_column_text] 1. Background and history The FDA (U.S Food & Drug Administration) was established in 1901 as a bureau of the Chemistry Department of Agriculture. Five years later, a Read More >>>
Cleaning Validation for Bio-pharmaceutical & Medical Device
Background The definition of "clean" is free from dirt, soil or impurities (chemical/microbial). The cleaning process intend to remove dirt, impurities and soil in addition to decontamination of the Read More >>>