WHICH IS THE BETTER LABORATORY QUALITY SYSTEM? OECD-GLP OR ISO/IEC 17025

A testing laboratory is accredited to OECD-GLP or ISO/IEC 17025 quality system as a way to assure its capability to conduct testing and report valid and reliable results needed in making importance decision, including in risk assessment. However, often there is confusion, which quality system the laboratory should implement for its testing. Hence, I'm posting the below presentation, hope it gives some clarification on how these two quality systems work hand-in-hand from the perspective of medical device biocompatibility testing. 

ALTERNATIVE TOXICITY TESTING METHOD FOR REGULATORY PURPOSE

Dear readers, inevitably toxicity testing scarifies animals in generating safety data for risk assessment to protect human and environment. In recent decades, advancement of technology and advocate by animal lovers have led to new ideas starting efforts introducing new test methods that replace, reduce or/and refine the use of animals while generating valid toxicity safety data. Hereby, sharing a presentation on this topic. May it be useful to you.

NETWORK OF NANOMETROLOGY & NANOSAFETY LABS IN ASEAN

Nanotechnology has introduced use of nanomaterials in industrial and consumer products. In view of its unique nature of size that is bigger than water molecule but smaller than bacteria raises safety concerns due to its capability to penetrate and travel within the human body like viruses. There are challenges in performing safety studies on nanomaterials. It is essential to assure when safety studies are perform, the materials remains at its nano-characteristics. As such NanoMetrology becomes important before the conduct of NanoSafety or NanoPerformance studies. The NanoMetrology studies require the use of high specification and expensive equipment. Hence, an effort has been initiated to network accredited laboratories within the ASEAN member states for a cost-effective utilization and offering of testing services to industrial customer regionally and internationally by complying with OECD-GLP or ISO/IEC 17025 quality assurance standards. Subsequently allowing the NanoSafety and NanoPerformance testings to be undertaken by the other partner laboratories within the network. The presentation introduces to list of NanoMetrology and NanoSafety laboratories within ASEAN that have pioneered this networking initiatives.

OECD? OECD-TG? OECD-GLP? & OECD-MAD?

Often there is misunderstanding between the various acronyms that starts with the word OECD. Hence, in this slide presentation, I made an attempt to clarify the difference and connection between the acronym of OECD, OECD-TG, OECD-GLP and OECD-MAD. Hope the presentation helps you to distinguish these acronyms.

Use of Computerised System in GLP Studies

Dear audience, recent decades as accelerated the use of artificial intelligent (robot brain) in replacing human tasks that are prone to errors or risks of occupational hazards or improving the productivity. Such advancement also seen in the laboratory operation. The use of artificial intelligence including automated instrumentation with software is known as "Computerized System" under the OECD-GLP quality system. Here I post a slide presentation to illustrate the use of Computerized System in non-clinical study that require adherence to OECD-GLP.

10 Steps in Optimizing OECD MAD in Embracing Technical Barrier For Sustainable Global Trade

Dear ASEAN entrepreneurs, geography of Southeast Asian has blessed with warm climate that allows continuous farming and business operation. Further its strategic positioning between China, India and Africa continents has enriched its flora and fauna. Hence, gives the ASEAN entrepreneurs huge potentials due to diverse resources and proximity of mega population markets. Hereby, a presentation to share 10 steps to facilitate in addressing the need of technical documents for purpose of multi-countries product registration, permit or pre-market authorization.

WHY REGULATORY BODIES PREFER OECD GLP?

Dear audience, hope this presentation able to illustrate the advantages of OECD-GLP Quality System to Regulatory Bodies in ensuring safety data been submitted to them is trustworthy in decision making for pre-market approval, authorization or registration.