WebDynamic image analysis is a method to determine the particle size distribution and particle shape of a sample by continuously photographing the silhouette of dispersed particles. In contrast to laser diffraction and DLS, particle shape and aggregation state can be determined by this measurement method. WebBioPharma Services Inc. Dec 2024 - Present2 years 5 months. Canada. conducted audits of clinical trials for compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, Health Canada, EMEA, etc.) • Reviewed Protocols and Informed Consent Forms (ICF)
Investigation to Identify the Root Cause of Out-of-Specification ...
Web9 de ago. de 2024 · OOS sample and control sample of the drug product were used “as-is” without further dilution (or sample preparation) for HPLC, HPLC–HRMS analysis, and … WebThe multi-laser technology provides an extensive range of measurable particle sizes. The single-laser PSA 990 covers a measurement range of 0.2 μm to 500 μm. For an even broader range, PSA 1090 and PSA 1190 have a unique optical design for diffraction analysis, which includes multiple lasers. While PSA 1090 has been designed with two … sonim xp6 belt clip
Q 7 Good Manufacturing Practice for Active Pharmaceutical …
WebPrecision also decreases as particle size decreases, so not very precise for 2-5um. • SVP what is the range: GNE would report 10-25-(50 for ophthalmology) and internally we trend 2-5. methods are not reliable at size smaller than 2 • Silicon oil: not considered harmful so could be justify an OOS, but not acceptable to be Web21 de fev. de 2024 · An OOS result occurs when an analytical result does not meet the applicable specifications. As a cGMP compliant and ISO 17025:2024 accredited … WebA laser-based particle analyzer is recommended for the finer fractions, which allows establishing the grain sizes for objects of 0.2 to 600 μm. In laboratory studies, a fine-class particle-size analysis was carried out using a Microsizer 201C instrument, designed for establishing particle-size distribution in liquid media. sonim xp6 specs