spacer
home > epc > autumn 2017 > top tips for clinical quality
PUBLICATIONS
European Pharmaceutical Contractor

Top Tips for Clinical Quality

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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Patricia Santos-Serrao, RAC, is a life sciences professional with over two decades of experience in quality, regulatory and clinical business processes for the pharmaceutical and biotech industries. She worked for several Tier 1 companies, including Schering-Plough and Boehringer Ingelheim, prior to transitioning to various technology solutions and services providers for life sciences. Currently, Patricia is Director of Pharmaceutical and Biologics Solutions at MasterControl, developing solutions designed for the pharma industry with a focus on clinical operations, quality and regulatory affairs.
spacer
Patricia Santos-Serrao
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

BBI Solutions broadens antibody portfolio and strengthens reagent technical support capabilities with acquisition of Maine Biotechnology Services

BBI, a leading manufacturer of raw materials and finished test platforms, already provides human antigens, antibodies, serum and plasma products and clinical chemistry enzymes, for the in-vitro diagnostics market. Now with the acquisition of MBS they have strengthened their antibody offering, providing a comprehensive portfolio and custom services to deliver a total reagent solution for any immunoassay development.
More info >>

White Papers

Successfully managing the unique demands of cell therapy supply chains

PCI Pharma Services

Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.
More info >>

 
Industry Events

3rd Annual Inhalation & Respiratory Drug Delivery Congress

8-9 May 2018, London, UK

Oxford Global are proud to present our hugely popular 3rd Annual Inhalation & Respiratory Drug Delivery Congress, 8th – 9th May 2018, London, UK. Over 300 delegates representing global pharmaceutical organisations, leading biotech companies and internationally renowned academic institutions will gather for over 20 presentations and case studies focused on the key issues in inhalation and respiratory drug delivery.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement