“Here’s the disinfectants we could use for our cleanroom facility, now what?” – Pharmaceutical manufacturing companies for medicinal products are to comply to the requirements set out in the PIC/S Guidance Document for Guide to Good Manufacturing Practice (GMP) for Medicinal Products in order to obtain the necessary certifications. While this is a heavy document,...
In 2021, the National Pharmaceutical Regulatory Authority (NPRA) established regulatory guidelines for surface disinfectants to undergo voluntary registration for the first time. Now, after 3 years and multiple minor amendments...
Did you know we are now one of the approved laboratories by Association for Applied Hygiene (VAH) in Germany? If you are thinking of penetrating the disinfection market in Germany, come learn about VAH certification and its efficacy requirements with us. What is VAH certification? VAH certification is a unique quality mark for disinfectant...
Have you seen that NPRA released the new Guidelines for Control of Cosmetic Products in Malaysia? This now includes more informative guidelines for registering hand sanitizer and hand wash products, especially so for non-alcohol-based hand sanitizer. Before we dive deeper into the new requirements for registering your hand sanitizers with NPRA, are you aware that...
“Hey, Robin, you know, most of our competitors already have a coronavirus claim on their products like us, and I’m not quite sure what can we do to stand out more.”—During the COVID-19 virus outbreak, most disinfectant manufacturers elevate their products’ uniqueness either by reducing the kill time to just mere seconds or to test...
“Hey, Joanne! NPRA has recently announced a voluntary registration for surface disinfectants in Malaysia starting from 10th September last year. Let’s register our product!”—The recent surge of surface disinfectant demand and placement in the current Malaysian market has alerted the Ministry of Health (MOH) to regulate these products. Ever since then, the MOH has appointed...
“Hey, Lim! You know, with the whole pandemic situation going on, I have produced my own line of hand sanitizers to help combat the virus. By any chance, would you know how to sell my product in Malaysia?”—Have you manufactured a hand sanitizer product or are you assisting a foreign manufacturer to register their product...
“Do you have a faster approach to test the shelf life of my disinfectant?” – Is this a common topic you wonder about too? The COVID-19 driven production of disinfectants in our current market has alerted governmental authorities globally to promptly facilitate these products into the market. With an interest to register your product in...
OECD-GLP and ISO 17025 are two different types of ‘certificate’ that shows the competency of a laboratory to perform testing. Not all test methods performed in an ISO 17025 laboratory are accredited. In order to offer ISO 17025 accredited test methods, the laboratory needs to perform method validation or verification and calculate the measurement uncertainty...