White Papers
Our white papers and technical bulletins are written by industry experts from many different fields, exploring and commentating on a range of complex subjects.
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Decoding FSMA Certification – A Practical Guide
This document provides a practical guide to understanding FSMA certification. |
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Benefits of Integrating Full Characterization to Early Method Development - Focus on SEC-MALS
COVID-19 has highlighted the need for faster methodologies when developing new drug products. We look at how integrating the SEC-MALS method at an earlier stage in the development process will accelerate speed-to-clinic without compromising patient safety. |
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Advancing the Detection of E&L by Pharma Manufacturers
In this document, we look at how coupling the headspace sampling technique with an HRAM GC-MS system delivers a powerful technique to quickly assess and quantify potentially dangerous, untargeted volatile extractables in pharma workflows. |
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Managing Human Challenge Trials: A Case Study
Volunteer Infection Studies (VIS) or Controlled Human Infection Models (CHIM) are an extremely effective way to gather early clinical evidence on efficacy, minimize potential risks, and maximize the outcomes when progressing a new drug or vaccine onto critical clinical studies. Their success relies on careful preparation by an experienced team that is capable of adequately managing the risks associated with the study. |
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Nitrosamine Testing: The Regulatory Aspects
In this technical bulletin we explain the regulatory aspects for nitrosamine impurities testing and provide more details on a risk assessment process. |
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Analysis of Discharge Water from Exhaust Gas Cleaning Systems
Two main regulatory frameworks, at international and national levels, are driving the requirements for shipowners to carry out tests of discharge water from exhaust gas cleaning systems. |
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Commissioning Testing of Ballast Water Management Systems
SGS conducts commissioning testing of ballast water management systems (BWMS) to determine compliance to the International Maritime Organization (IMO) D-2 discharge standard following the commissioning guidelines as set out in BWM.2/Circ.70. |
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eSource Arising: Clinical Data Automation Possibilities Beyond Data Capture
When implementing the 1st generation of eSource system at SGS, the focus was on facilitating data capture and converting clinical data directly to a Study Data Tabulation Model (SDTM), making eCRF redundant. After getting familiar with eSource, we are now ready to use our knowledge and expertise and take eSource clinical automation to the next level with the 2nd generation of eSource system. This paper will highlight our acquired insights and the challenges faced from both systems, resulting in improved efficiencies. |
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Self-Assessment Checklist for Innovation Management System
This self-assessment checklist was adapted from ISO 56002:2019, the latest version of the ISO 56002 standard. It has been designed to help you to understand the key focus areas of this standard and identify immediate gaps in your present system. |
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創新管理系統自我評估檢查表
這份自我評估檢查表是根據最新的 ISO 56002:2019 標準改編而成。它旨在幫助你了解標準中的重點領域，並幫助分辨與你目前系統中有何差距。 |