Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and ...
This webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025:2005 for laboratory accreditation in food/water ...
The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...
3M Food Safety’s assay to detect E. coli O157 (including H7) has received an NF Validation certificate from AFNOR Certification. It was found to be as or more effective than the EN ISO 16654 method ...
Dublin, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The "3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA/EMA, USP and ICH" training has been ...
Analytical techniques for validating cleaning methods must evolve to match the pace of an increasingly complex manufacturing landscape for new therapeutics. Within the bio/pharma industry, there is a ...
The Indian Pharmacopoeia Commission (IPC) has released draft chapter on "Approach to alternative rapid microbiological methods” for stakeholder comments for effective diagnostic practices. The purpose ...
Harmonization describes a process of synchronising various test strategies and protocols. With so many different methods and testing procedures in the published literature, it can be a daunting ...
Method validation and method verification are two distinct procedures required to combat food bioterrorism/ comply with ISO/IEC Standard 17025:2005 for a microbiological media laboratory accreditation ...
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