Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

Almac Receives FDA Inspection Approval

Published: Thursday, February 21, 2013
Last Updated: Wednesday, February 20, 2013
Bookmark and Share
Successful inspection of analytical facilities at Almac’s Craigavon Headquarters, Northern Ireland from the US FDA.

Following from successful MHRA audits in 2011, Almac’s Sciences Business Unit has completed a successful inspection of its analytical facilities at its Craigavon Headquarters, Northern Ireland from the US Food and Drug Administration (FDA).

The inspection concluded with no objectionable conditions (483 observations) nor recommendations for improvements.

The inspection of the control testing laboratory was in support of pre-approval inspections for products for which Almac Sciences are named as the contract test laboratory.

The 3-day inspection covered the Quality and Laboratory Control systems and included tours of all test laboratories and specialist analytical facilities including mass spectroscopy laboratories.

Commenting on the approval, President and Managing Director, Stephen Barr said: “We are delighted with the outcome of this inspection. We have now established a track record with both authorities which highlights our strong focus on compliance and regard for regulatory standards. This outcome is even more significant with the completion of our expanded API facility, and focus on late phase clinical development projects. Our clients can be further assured that our systems and procedures are robust and their products will be delivered to the highest quality.”

Alan Chambers, Head of Quality Assurance added, “This success confirms Almac’s dedication to delivering the highest quality standards. To complete this inspection with no findings is testament to the knowledge and expertise of the entire Almac workforce. We are committed to building on these strong foundations with continual investment within our quality systems.”

Almac has announced expansion of its manufacturing and support facilities at its Craigavon plant.

These include an extended API facility, which doubles the current GMP Active Pharmaceutical Ingredients (API) manufacturing capacity, and expansion of its stability storage chambers with also a doubled capacity increase.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More Than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Almac Group Addresses Industry Demand For Multiparticulate Drug Products
In response to increasing client demand for multiparticulate drug delivery systems, Almac Group is providing fluid-bed processing and encapsulation services to its global partners from its UK development and commercial manufacturing facilities.
Monday, October 12, 2015
Almac Addresses Industry Demand for Multiparticulate Drug Products
Company is providing scalable fluid bed and encapsulation technologies to its global partners.
Friday, October 09, 2015
Almac Group Expands Asia Pacific Presence
Company opens new regional headquarters and clinical trial supply facility in Singapore.
Thursday, July 16, 2015
Novozymes Biopharma Announces Collaboration with Almac
Combined service offers drug development companies efficiencies in time and resource.
Tuesday, October 22, 2013
Almac Expands US & UK Commercial Facilities
Investments of over $20m enhance Almac’s commercial facilities on both sides of the Atlantic.
Tuesday, October 22, 2013
Almac Announces Further Expansion and 229 New Jobs
Dual expansion with completion of a new non-GMP drug development facility.
Monday, June 17, 2013
Almac Launches US Commercial Packaging Operations in Audubon
Company also announces launch of new client partnership.
Monday, May 20, 2013
Almac Doubles Drug Product Development Capacity with a New Non-GMP Facility
New facility offers clients greater flexibility and speed in formulation and process development.
Tuesday, January 15, 2013
Almac and TTP Labtech form Alliance in Fluorescence Lifetime Technology
This will give customers of either party access to a broad range of biological applications coupled with the next generation of microplate reader technology.
Tuesday, January 08, 2013
Charlie Morris Appointed to Almac’s Clinical Technologies Executive Team
Mr. Morris joins Almac as Vice President of new products and services.
Thursday, December 13, 2012
Almac Concludes Commercial API Manufacturing Facility Expansion Plans
Almac’s expansion is near completion and will be operational by the end of the year.
Tuesday, October 09, 2012
Almac Expands UK Commercial Capacity
Acquisition of new Noack N 623 blister packaging line from Romaco.
Friday, October 05, 2012
Almac Installs Uhlmann Blister Line in New US Commercial Packaging Facility
Acquisition of a high-speed blister line in Audubon, PA.
Monday, July 02, 2012
Almac Introduces QP Facilitation Programme for Conducting Trials in the European Union
Programme vastly simplifies and expedites the QP release process.
Thursday, June 14, 2012
Almac and VTU Technology Form Collaboration
Approach enables homogenous labelled product with retained biological activity.
Tuesday, June 12, 2012
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Promising Drug Combination for Advanced Prostate Cancer
A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.
A Cellular Symphony Responsible for Autoimmune Disease
Broad Institute researchers have used a novel approach to increase our understanding of the immune system as a whole.
When it Comes to Breast Cancer, Common Pigeon is No Bird Brain
If pigeons went to medical school and specialized in pathology or radiology, they’d be pretty good at distinguishing digitized microscope slides and mammograms of normal vs. cancerous breast tissue, a new study has found.
Editing of LIMS Data Made Faster and More Efficient in Matrix Gemini
The latest version of the Matrix Gemini LIMS (Laboratory Information Management System) from Autoscribe Informatics now provides faster and more efficient editing of LIMS data by eliminating the need for a second editing screen.
University of Edinburgh, Selcia Achieve Key Milestones in Drug Development Program
Scientists from the University of Edinburgh, working with Selcia, have successfully passed the 20-month milestone targets of a 30-month Wellcome Trust SDDi £2.5 million project to design novel treatments for sleeping sickness.
Red Clover Genome to Help Restore Sustainable Farming
The Genome Analysis Centre (TGAC) in collaboration with IBERS, has sequenced and assembled the DNA of red clover to help breeders improve the beneficial traits of this important forage crop.
How a Genetic Locus Protects Adult Blood-Forming Stem Cells
Mammalian imprinted Gtl2 protects adult hematopoietic stem cells by restricting metabolic activity in the cells' mitochondria.
Genetic Basis of Fatal Flu Side Effect Discovered
A group of people with fatal H1N1 flu died after their viral infections triggered a deadly hyperinflammatory disorder in susceptible individuals with gene mutations linked to the overactive immune response, according to a recent study.
New Tech Vastly Improves CRISPR/Cas9 Accuracy
A new CRISPR/Cas9 technology developed by scientists at UMass Medical School is precise enough to surgically edit DNA at nearly any genomic location, while avoiding potentially harmful off-target changes typically seen in standard CRISPR gene editing techniques.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos