عنوان فارسی مقاله: آماده سازی مراحل خدمات کالیبراسیون و روش های تایید در حمایت از CMCs


عنوان انگلیسی مقاله:

Preparing Calibration Service Procedures and Validation Methods in Support of CMCs






 

فهرست مطالب

Preparing Calibration Service Procedures and Validation Methods in Support of CMCs

CMC review example

NRC CMC in Time and Frequency

Calibration Approach

Calibration Procedure: FTS-FREQMEAS

Calibration Procedure: FTS-FREQ_CNTR_CAL

Calibration Validation

Calibration Validation: Setup

Results

Calibration Validation: Setup

Frequency Measurements with HP system

Time Interval counter readings at non-integer frequencies

Frequency Measurements with HP system part 3

Calibration Validation: Setup

Calibration Validation

Frequency Measurements with CNT system,CNT measurements validation against HP system (traceable to UTC via CCTF-K001.UTC

Calibration Validation

Frequency Measurements with 1Vpp, 120ns rise time

Calibration Validation: Frequency Counter Calibration using Known Frequencies

Frequency Counter Calibration using Known Frequencies

Summary





بخشی از مقاله

Summary

The validation had verified the measurement capability and the traceability to the levels exceeding CMC specifications

The frequency counter calibration procedure was developed and the counter was calibrated








 

کلمات کلیدی: 

Validation Practices for Biotechnology Products https://books.google.com/books?isbn=0803124058 J. K. Shillenn - 1996 - ‎Technology & Engineering There are requirements for documenting the calibration procedures to be used ... their own SOP's prepared, and not depend on a service company's procedures. [PDF]analytical quality control - European Commission https://ec.europa.eu/food/sites/food/.../pesticides_mrl_guidelines_wrkdoc_11945.pdf Jan 1, 2016 - Service Commun des Laboratoires, Montpellier, France ... Appendix A. Method validation procedure: outline and example approaches ______ 26 ..... multi-pesticide calibration standard solutions prepared in pure solvent ... Searches related to Preparing Calibration Service Procedures and Validation analytical recovery definition standard operating procedure guidelines calibration blank definition recovery calculation in method validation recovery method validation sop preparation guidelines calibration curve method quantitative analysis standard operating procedure sample pdf