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:2/12/2016)... Ungarn, February 12, 2016 ... sich auf den ungedeckten medizinischen Bedarf bei ... Ergebnisse seines klinischen Forschungsprogramms bekannt. Das Programm, ... ergab Verbesserungen ihrer respiratorischen Funktionen und anderer ... , ein Medizintechnikunternehmen, das sich auf den ...
(Date:2/12/2016)... , Maharashtra, February 12, 2016 ... Market research report titled Chronic Inflammation Global Clinical ... a snapshot of the global clinical trials landscape ... clinical trials by Region, Country (G7 & E7), ... point status and reviews top companies involved and ...
(Date:2/11/2016)... -- - Cardiac Marker Diagnostic Testing ... Cancer Therapy. - European Point of Care Diagnostic ... - Key Diagnostic Testing Markets. - Molecular Diagnostics ... Testing. - Molecular Diagnostics in Infectious Disease Testing. ... Products World Markets. - Point of Care Diagnostic ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... , ... US Sport Camps is pleased to announce the addition of junior ... as the host site and directing the camps is PGA Professional and 2008 Iowa ... in recent years around Des Moines and are fortunate to have such a well-respected ...
(Date:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... A lot ... past 35 years. A president has access to health and wellness resources most Americans ... free world, no single individual has a schedule as frenetic as the U.S. President. ...
(Date:2/12/2016)... ... February 12, 2016 , ... Healthcare careers in the medical laboratory, nursing, ... via the website of healthcare staffing leader Aureus Medical Group during the month of ... travel therapy positions and in travel and direct hire opportunities in other ...
(Date:2/12/2016)... ... , ... The Central Coast Autism Spectrum Center (CCASC) invites teens ages 11-18 to its annual ... for teens with and without special needs to gather in a safe and supportive environment. ... dance will take place on Saturday, Feb. 13 from 7 to 9:30 p.m. at Elks ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... in the field of long term care. With that, says Patrick Loughney, president ... professionals in administrative roles in long term care environments. His company, which offers ...
Breaking Medicine News(10 mins):