Navigation Links
Almac's Clinical Technologies Division Undergoes Successful Joint GCP-GMP MHRA Inspection
Date:9/21/2010

Almac's Clinical Technologies Division Undergoes Successful Joint GCP-GMP MHRA Inspection -- YARDLEY, Pennsylvania, September 21, 2010 /PRNewswire/ --


Advanced Search Search

  
Close
  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Health Care & Hospitals, Medical Pharmaceuticals, Pharmaceuticals, Clinical Trials & Medical Discoveries Click to view news release full screen  

Almac's Clinical Technologies Division Undergoes Successful Joint GCP-GMP MHRA Inspection

 

YARDLEY, Pennsylvania, September 21, 2010 /PRNewswire/ -- Almac's Clinical Technologies division announced today that it had successfully passed one of the UK's first joint routine GCP/GMP Medicines and Healthcare Products Regulatory Agency (MHRA) inspections at its Craigavon, UK site. This involved senior MHRA inspectors from both its GCP and GMP areas assessing compliance with UK and European legislation.

The MHRA inspection was conducted on the GMP side to determine whether Almac's IXRS integrated phone and web response system was able to adequately ensure that expired products were not shipped to sites or dispensed to patients at clinical trial sites. Additionally the system was reviewed in general terms for its compliance with Good Clinical Practices (GCP). Almac Clinical Technologies received notice from MHRA that no serious findings were found in any of these areas or others investigated by the regulatory agency.

This was the first time in its history that Almac's Clinical Technologies division has been inspected by a regulatory authority. The inspection was conducted as part of a routine inspection plan and process of MHRA and was not triggered by any particular events, issues, or potential violations at Almac. MHRA routinely conducts inspections of both pharmaceutical companies and associated vendors who are involved in clinical trials. The results of the MHRA inspection were reported to Almac on 3 September 2010 after the company was inspected from 23-25 August 2010.

Jim Murphy, President of Almac's Clinical Technology division comments on this significant milestone: "The highly successful results of our first-ever regulatory inspection validate the efforts of all Almac employees to deliver the highest quality GCP and GMP systems and services to our clients. We take great pride in Almac's specialized full supply chain solution involving patient, site and drug management services, which are delivered using our IXRS technology. As patient safety is a key concern for Almac, we employ every effort to assure that patients in clinical trials are provided with products that are managed carefully to prevent expiration and meet all the requirements defined and monitored by regulatory agencies."

Bill Kane, Director of Quality Assurance for Almac's Clinical Technologies division, notes that Almac was not surprised by the results, given the company's long history of delivering quality systems and services to biopharmaceutical clients. "Almac has very stringent quality SOPs that clearly define and guide the way we build systems for our clients and manage the drugs that patients take during clinical trials. The MHRA inspection validates the quality procedures that Almac has put in place and offers another testimony to our focus on providing high quality technologies and services to biopharmaceutical companies worldwide. We typically excel at client audits and now have passed another key test - an MHRA inspection."

About Almac Group

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.

The company employs over 2,700 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120m North American Headquarters which started in July 2008 and employees will relocate during the fall. .

Almac's Clinical Technologies division specializes in interactive technology and service solutions to increase the quality and efficiency of the clinical trial process. Our solutions include Interactive Voice and Web Response Systems (IXRS(TM)) for patient randomization, tracking and clinical supply management, electronic-patient-reported- outcomes data collection, and Web drug reconciliation. Almac's technologies have been deployed in over 1500 clinical trials, incorporating over 1.5 million patients in over 80 countries, and more than 60 languages.

For more information about the Almac Group, please visit http://www.almacgroup.com or e-mail info@almacgroup.com.

http://www.almacgroup.com


'/>"/>
SOURCE Almac Group
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
6. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
7. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
8. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
9. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
10. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
11. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... Feb. 9, 2016  Axovant Sciences Ltd. (NYSE: ... the treatment of dementia, today announced further details ... behavioral and functional aspects of Lewy body dementia, ... the U.S. Two out of the three studies ... to start later this quarter. In addition, the ...
(Date:2/9/2016)... The new report "Global Diagnostic Ultrasound Devices Market Assessment ... reveals that global diagnostic ultrasound devices market was valued at US$ ... million by 2019 at a CAGR of 6.8% from 2015 to ... has been analyzed for six geographies of North America ... , Latin America , Middle-East ...
(Date:2/9/2016)... 9, 2016 The new report "Global Blood Monitoring & Cardiac Monitoring ... & Consulting group reveals that global market for blood monitoring & ... and expected to grow to US$ 24,830.1 million by 2019 at ... North America , Europe , ... Middle-East and Africa . The three ...
Breaking Medicine Technology:
(Date:2/9/2016)... (PRWEB) , ... February 09, 2016 , ... ... Transformation Solutions, LLC to help enterprises move workloads to the cloud. Cirracore ... connect to their cloud without traversing the Internet. Transformation Solutions (TSL Partners) ...
(Date:2/9/2016)... ... , ... Establishment Labs, a global breast implant and medical technology company, is ... Directors. , “We are honored to welcome David to our Board of ... Chacon Quiros, CEO of Establishment Labs. "David’s knowledge and experience will be invaluable to ...
(Date:2/9/2016)... ... February 09, 2016 , ... The Bon-Ton Stores, ... Younkers department stores, announced it has raised $176,000 to benefit the Breast Cancer ... Cancer Center at the University of Iowa, The Lynn Sage Cancer Research Foundation, ...
(Date:2/9/2016)... ... ... METTLER TOLEDO has published a new guide entitled “Essential ... the techniques they use so they can more easily spot potential error sources ... to create a leaner overall lab experience. , The new guide offers ...
(Date:2/9/2016)... ... February 09, 2016 , ... United Methodist Communications ... of Prevention,” an animated video designed to prevent the next widespread ... the video are being distributed throughout Togo, Liberia, Sierra Leone, Nigeria, Côte d’Ivoire ...
Breaking Medicine News(10 mins):