GMP Facility:

Content Related to GMP Facility



• GMP Guidelines Good manufacturing process (GMP) guidelines are essential to ensure drugs are produced to a consistently high quality. GMP guidelines should be implemented at all stages of the manufacturing process to eliminate the possibility of risks, that may not be detected during clinical trials. If GMP guidelines are not correctly implemented, there is a risk that poor quality and substandard pharmaceutica....Read more

  Contributor:  Pharma IQ Tags: GMP guidelines | GMP guidelines FDA | GMP guidelines food 09/06/2010  12:00:00 AM EDT

• Focus on the Creation of a Patient-Centered Framework Dr. Eric Chan, Senior Hospital Manager – Facility Management, for Kwong Wah Hospital, Hospital Authority, HKSAR, discusses the importance of initial capital cost, stand-alone facility systems, and new sophisticated facility technology with Pharma IQ's Bryan Camoens. He also examines the evolution of health facilities in Asia. Pharma IQ: Could you please highlight the do’s and don&....Read more

  Contributor:  Bryan Camoens Tags: Eric Chan | facility management | hospital efficiency 09/07/2010  12:00:00 AM EDT

• Opportunities and Challenges for New Chinese GMP Compliance When the State Food and Drug Administration (SFDA) of China launched its new good manufacturing practice (GMP) guidelines in March 2011, it presented a list of new opportunities and challenges for what is to become the world's third largest pharmaceutical market by 2012. The guidelines were the result of five years of adaptations and two public consultations and the SFDA admitted that compared t....Read more

  Contributor:  Pharma IQ Tags: GMP | Chinese GMP Compliance | Chinese pharmaceutical companies 09/30/2011  12:00:00 AM EDT

• Creating a Blueprint for Healthcare Facility Planning, Construction, Commissioning and Management South Africa's healthcare industry is on the cusp of a revolution. The recently introduced National Health Insurance (NHI) White Paper lays out a plan which would see the country's under-developed healthcare system changed beyond recognition over a 14-year period. In a statement released in October 2010, the director general of South Africa's National Department of Health, said: "NH....Read more

  Contributor:  Pharma IQ Tags: healthcare facility planning | healthcare facility construction | healthcare commissioning 04/19/2011  12:00:00 AM EDT

• Unlocking the Value of Strategic Partnerships with CRO’s and Pharmaceutical Companies in Asia Introduction Considering potential benefits and the impact of pitfalls of any Asian offshoring ambitions you need to analyse your situation and intentions first to establish the right base to unlock the value of your planned strategic partnerships or any other Asian ambitions which might be based on different business models than partnerships. The pharmaceutical industry started to offshore rel....Read more

  Contributor:  Frank Floether Tags: Frank Floether | Asian offshoring | strategic partnerships 03/02/2011  12:00:00 AM EST

• Ten Rules of Good Manufacturing Practice Good Manufacturing Practice (GMP) refers to the rules governing the manufacture of a safe and efficacious pharmaceutical product.  There are two main global bodies that oversee GMP. These are the U.S. Food and Drug Administration (FDA), where manufacturers are governed by the Code of Federal Regulations (CFRs), in particular 21 CFR 210 – 211, and the European Union (EU GMP), which is overseen ....Read more

  Contributor:   Tags: Ten Rules of Good Manufacturing Practice | GMP | An introduction to GMP: The Basic Rules 04/08/2013  12:00:00 AM EDT

• Legal Flash: 8 Regulations set to impact the Pharma & Biotech Industry in 2013   Pharma IQ has put together a list of 8 regulations and guidelines that look set  to impact different divisions of the biotech and pharma industry in 2013. ONE: Good Distribution Practice (GDP) 2013 The revised European Commission Guidelines on the distribution of medicinal products in the EU will come into force in September 2013.   Good distribution practice (GD....Read more

  Contributor:  Niamh Madigan Tags: 8 regulations impacting the Pharma / biotech Industry 2013 | GDP | FDASIA 04/15/2013  12:00:00 AM EDT

• 	Ensuring Long Term Sample Integrity through Effective Monitoring of Storage Conditions Ensuring Effective Data Management and Promoting Effective Sample Control In this presentation Peter Jackson , Managing Director, ELPRO UK, discusses why monitoring is required in biobanks, where should be monitored, specific challenges for monitoring in biobanks and features to consider when choosing
  Tags: biobanking | biobanks | Peter Jackson

• CMO-Client Relationships: Extremes and Standardisation Ian Anderson Director, External Networks, M&S Business Unit Norgine, spoke to Pharma IQ about the evolution of the CMO-pharmaceutical relationship.  How would you say Contract Manufacturing Organisation (CMO) service offerings are evolving? One trend I have seen over the last ten years is contract manufacturers rarely don’t meet the basic Good Manufacturing Practice ....Read more

  Contributor:  Ian Anderson Tags: Ian Anderson | CMO | CMO customer service 06/25/2010  12:00:00 AM EDT

• 	Managing Quality Relationships with CMOs is Critical for Success In this Pharma IQ podcast, Diane Petitti, Vice President, Quality at Amylin Pharmaceuticals, speaks to Andrea Charles from Pharma IQ, about the current challenges relating to domestic and overseas outsourced manufacturing and how to determine the best CMO for your company's needs. Petitti
  Contributor:   Pharma IQ Tags: Diane Petitti | contract manufacturing | quality 09/16/2010  12:00:00 AM EDT

• European Medicines Agency's Fergus Sweeney: Increasing Inspection Coverage in the Wake of Globalisation Wherever you sit in the world as a regulator, most of the clinical trials you receive in marketing applictaions, most of the manufacturing that takes place for products is taking place in terrioties outside of the juristicion of your regulatory system. In this interview Fergus Sweeney, Head of Compliance

  Tags: Fergus Sweeney | EMA | European Medicines Agency

• 	Ensuring High Levels of GCP   What are the 7 Deadly Sins of Quality Assurance and Quality Control? Download our free QA QC eBook now to find out!   Amer Alghabban, head of GCP Auditing Group at Merck Serono, joins Pharma IQ to discuss the implementation of GCP and effective auditing of cl....Read more
  Contributor:  Helen Winsor Tags: Amer Alghabban | GCP | Good Clinical Practice 02/08/2011  12:00:00 AM EST

• Scale-Up and Manufacturing of Regenerative Medicine  When introducing a regenerative medicine cell based product to a commercial setting, there are a number of things to take into consideration to ensure a commercially viable and safe product for patient use. In this Q&A interview, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some great insights into the commercial manufacturing scale-up process of cell therapies. P....Read more

  Contributor:  William Fodor Tags: regenerative medicine | GMP | cGMP 10/06/2011  12:00:00 AM EDT

• Increasing Inspection Coverage in the Wake of Globalisation; European Medicines Agency's Fergus Sweeney
  

  In support of our European activities, the European Medicines Agency (EMA) also has a role in the harmonisation of inspection procedures, and consequently we run clinical  and manufacturing practices and Pharma co-vigilance inspectors’ working groups where all of the national competent authority inspectorates are represented, because EMA itself doesn’t do inspections. We work with the in....Read more
  

  
  Contributor:  Fergus Sweeney
  Tags: EMA | Euroepan Medicinces Agency | compliance
  03/08/2012  12:00:00 AM EST

• Post & Pre Marketing Pharmacovigilance in Asia by 2020: Solvay Pharmaceuticals Dr. Rashmi Hegde, Solvay Pharmaceuticals’ Director Pharmacovigilance Asia-Middle East-Australia-Canada expects to see “mature post-marketing regulations and acceptable regulations with respect to pre-marketing PV” and “PV regulations to be strictly enforced” in Asia by the year 2020. Dr. Hegde made these comments to Pharma IQ’s Divya Sangam in an exclusive intervi....Read more

  Contributor:  Rashmi Hegde Tags: Rashmi Hegde | Solvay Pharmaceuticals | pharmacovigilance 07/04/2011  12:00:00 AM EDT

• Automation Considerations for RNAi Library Formatting and High Throughput Transfection The ICCB-Longwood Screening Facility at Harvard Medical School is a resource for academic investigators carrying out small molecule and genome-wide siRNA screens. When they began supporting siRNA screens in 2006, they adapted work flows for library management and formatting that they had developed for their small molecule libraries. In this interview, Sean Johnston, Facility Manager, Assay Implementation....Read more

  Contributor:  Sean Johnston Tags: Sean Johnston | compound management | compound integrity 07/17/2012  12:00:00 AM EDT

• Constructing an Integrated Chemical and Test Data Management System to Industrial Standards
  

  Reiner Dieden PhD, Analyst and Physical Chemistry and Logistics Director from UCB, joins Pharma IQ to discuss the development of a Compound Management Facility at the University of Bonn. Pharma IQ: Could you give us a brief overview of your role? R Dieden: As you mentioned in the introduction, I’m responsible for Analytical and Physical Chemistry, as well as Logistics, which is the local ....Read more
  

  
  Contributor:  Reiner Dieden
  Tags: Reiner Dieden | UCB | data management
  04/26/2011  12:00:00 AM EDT

• Is Your Biobank Lean? Jon Wetzel, founder of the Lean for Everyone blog, joins Andrea Charles from Pharma IQ  to discuss recent technological and commercial trends in the biobanking sector. Pharma IQ: What technological and commercial trends have you seen in the biobanking sector recently? J Wetzel: I think we’ve seen a slow shift from the big experiment to the smaller, discrete datasets that are more cus....Read more

  Contributor:  Jon Wetzel Tags: biobanks | biobanking | biobanking sector 04/27/2011  12:00:00 AM EDT

• 	Building a Compound Management Facility – The Integration Challenge Reiner Dieden PhD, Analyst and Physical Chemistry and Logistics Director from UCB, joins Helen Winsor Pharma IQ, to report on the development of a compound management facility at The University of Bonn.  He discusses the challenges faced by the NeuroAllianz Consortium – including managing
  Contributor:   Helen Winsor Tags: Reiner Dieden | UCB | compound management facility 03/31/2011  12:00:00 AM EDT

• 	Merck Investigates Alternative Strategies: An Interview about DMSO Hydration The Merck High Throughput Research Facility investigates alternative compound management strategies. One of these is DMSO Hydration. In this Pharma IQ podcast we talk to Ed Hudak, Sr. Research Engineer at Merck & Co., where research is being done to saturate DMSO – and the findings are promising.
  Contributor:   Amber Scorah Tags: Ed Hudak | Merck & Co | compound management 07/07/2011  12:00:00 AM EDT

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