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European Pharmaceutical Contractor
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Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) are fundamentally similar, in that the goal of each is to refine processes to ensure quality and facilitate conformance to regulatory guidelines. Both fall under the umbrella of good ‘execution’ practices (GxPs), which is intended to ensure consistency, data integrity, accountability, traceability and overall quality.
Understanding Operational Efficiencies
To see how GMP strategies can benefit the clinical world, it is necessary to thoroughly comprehend what a quality management system (QMS) is and what it is intended to do. A QMS is the collective set of policies, procedures, methods, resources, documentation and infrastructure required for the effective implementation of quality control and assurance in an organisation. The focus of these interrelated processes and activities is the achievement of quality objectives and policy that allow companies to execute measurable and repeatable procedures that meet regulatory requirements.
While some firms still rely on paper-based QMS operations, the use of a variety of hybrid paper-electronic systems or fully electronic QMSs is now more common. Historically, the QMS software solutions on the market have included modules for managing documents, training, quality events and reports/analytics. Automated QMS products currently on the market feature solutions specifically designed to manage other quality-related areas, such as audits and suppliers, under a single platform. While many enterprise QMS solutions are installed on premise, technological advances have spurred a trend of life sciences companies adopting cloud-based QMS solutions.
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News and Press Releases |
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Phenomenex Introduces bioZen Series for Characterization of Biotherapeutics
Torrance, Calif. (April 16, 2018) – Phenomenex Inc., a global leader in
the research and manufacture of advanced technologies for the separation
sciences, introduces bioZen – a new series of LC solutions for bioseparations
in pharmaceutical, biopharmaceutical and academic research. The series
encompasses both proven and entirely new media spanning two particle platforms
– core-shell and thermally modified fully porous – along with new biocompatible
titanium hardware. The initial bioZen product line features seven chemistries
for the UHPLC and HPLC characterization of biotherapeutics such as monoclonal
antibodies, antibody-drug conjugates and biosimilars. The offering includes
specific LC chemistries for the analysis of aggregates and total mAb, intact
mass and fragments, peptide mapping and quantitation and glycan mapping.
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White Papers |
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Conveying Medical Guidance in Clinical Trials – A Survey
Europital Medical Consultancy
With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project.
When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
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Industry Events |
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PPMA SHOW 2018
25-27 September 2018, NEC, Birmingham, UK
The UK’s leading production line event is celebrating
its 30th Anniversary. Taking place at the NEC, Birmingham from 25-27
September 2018, the exhibition showcases the latest processing and packaging
machinery. Attended by thousands of manufacturers of food, pharmaceuticals and
FMCG as well as contract packers and more.
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