Navigation Links
CPhI Report Indicates a Need for Greater Third Party Certification to Ensure GMP Vigilance
Date:7/26/2013

pondents, are a result of new drug targets becoming more complex and suffering from solubility issues and poor release profiles. Over two thirds of the pharmaceutical sector suggested 'bioavailability' and 'stability' were pressing challenges for the industry today, with 'dissolution' and 'release' profile also being sources of major concerns for over half the industry.

Solid dosage forms of tablets and capsules still represent 70% of the market with particle size reduction (60%) and tableting and compression (20%) seen as the most difficult to control operations. One solution to this problem could be an increased use of cross-functional teams, with 21% actively hiring and 35% planning to hire more material scientists.

"Material science is a good addition to the diverse range of expertise required for good QbD" notes Carlin. Already we are seeing PAT and QbD are being used more in formulation projects with 35% saying they are using both and a further 36% planning to use them in the near future.  

Yet despite these encouraging signs Ciurczak is critical of the industries hesitance "so 65% of the respondents are waiting to see if QbD really works… when the concepts have already been proven to work in every other industry in the world, from cake mixers to cars". However, Carlin has a more optimistic outlook, especially since the FDAs Office of Generic Drugs is encouraging the adoption of QbD. "The ANDA checklist in being updated to include elements of QbD and as such ANDAs will not be accepted for filing without these elements".

The report concludes that overall the pharmaceutical API and ingredients market is becoming more global and competitive and as regulations change the overall business environment and drug manufacturers will have to adopt. "Companies in the EU and the US have to work with their suppliers to emphasize the value of quality. Quality can no l
'/>"/>

SOURCE UBM Live
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Abaxis Reports Financial Performance For The First Quarter Of Fiscal 2014
2. Mettler-Toledo International Inc. Reports Second Quarter 2013 Results
3. DNA Sequencing 2013 Research Report: Market Developments, Growth Areas and Opportunities
4. NxStage Reports Record Revenue For The Second Quarter Of Fiscal 2013
5. CryoLife Reports Record Second Quarter Revenues
6. Shire Reports 7% Product Sales Growth: Anticipating Double Digit Non GAAP Earnings Growth in 2013
7. Nutraceutical Reports Fiscal 2013 Q3 Results
8. Varian Medical Systems Reports Results for Third Quarter of Fiscal Year 2013
9. Water Treatment Industry Reports: Equipment Research for US & Global Wastewater Treatment Markets
10. InterMune Reports Second Quarter 2013 Financial Results And Business Highlights
11. Sangamo BioSciences Reports Second Quarter 2013 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... , Sept. 17, 2014 Mindray (NYSE: ... officially released worldwide. The system has been showcased for ... during 14-17th September, and is scheduled for ... Designed to be the most efficient workhorse in ... diagnostic tools with a perfectly optimized user experience including ...
(Date:9/17/2014)... , September 17, 2014 ... to congratulate Biocartis commitment in shipping its first ... long-time investor in Biocartis as part of Debiopharm ... fully automated, real-time PCR based molecular diagnostics system, ... access to clinical molecular diagnostic information, anywhere and ...
(Date:9/16/2014)... Hologic, Inc. (NASDAQ: HOLX ... del Tomcat, un nuovo strumento preanalitico marcato CE ... automatizzata, progettata per semplificare la fase preanalitica ed ... errore legati alla gestione manuale dei campioni. ... riduce il carico di lavoro legato al trasferimento ...
Breaking Medicine Technology:Quality Exams at Your Fingertips 2Debiopharm Diagnostics Portfolio Company Biocartis Ships its First Idylla Instrument 2Hologic annuncia il lancio dello strumento preanalitico Tomcat in Europa 2Hologic annuncia il lancio dello strumento preanalitico Tomcat in Europa 3
... Par Pharmaceutical Companies, Inc. (NYSE: PRX ) will ... Friday, January 6, 2012 at the Millennium Hotel, 145 West ... Patrick G. LePore, and other members of the senior management ... current products and pipelines, and business outlook to analysts and ...
... Concord Medical Services Holdings Limited (the "Company" or "Concord ... largest network of radiotherapy and diagnostic imaging centers in ... Twelfth Annual CCM Academic Conference in Beijing on December ... conference, doctors and researchers shared their clinical and academic ...
Cached Medicine Technology:Concord Medical Completes its Twelfth Annual Academic Conference 2Concord Medical Completes its Twelfth Annual Academic Conference 3
(Date:9/17/2014)... 2014 As kids settle back ... top of mind for parents, teachers and coaches. ... about concussions and an informative video, Pediatric Concussions: ... coaches and teachers to detect, talk about and ... a pediatric orthopedic surgeon, I witness youth sports ...
(Date:9/17/2014)... 17, 2014 ICS Learning Group, Inc. ... Excellence in Training for the Best Use of Games ... on an online operational safety training module that ICS ... operation. Using an approach that combined realistic 3D ... that was similar to a video game, including competition ...
(Date:9/17/2014)... CA / MANILA, PHILIPPINES (PRWEB) September 17, 2014 ... providing Managed Operations and Business Process Outsourcing (BPO) services ... joined the firm as the Senior Vice President – ... U.S.. , Cary Weltken is a 15 year ... a wealth of experience in helping companies, ranging in ...
(Date:9/17/2014)... Freeslate, Inc. , the ... drug development, today announced that Baylor University acquired ... System to both support Baylor research interests and ... high throughput system is expected to significantly accelerate ... optimization for small molecule organic chemistry. , The ...
(Date:9/17/2014)... 17, 2014 Luxury Barber, the purveyor ... their newest addition to the Regenepure family: The Regenepure ... with nourishing and beneficial ingredients including biotin, silk proteins, ... with ample moisture, while also encouraging volume and shine. ... to complement the Regenepure DR doctor recommended ...
Breaking Medicine News(10 mins):Health News:Video Helps Kids and Adults Talk About Concussion Recognition and Treatment 2Health News:ICS Learning Group Wins Gold in the 2014 Brandon Hall Excellence Competition for Best Use of Games and Simulations for Learning 2Health News:MicroSourcing Appoints New Senior Vice President of North America 2Health News:Baylor University Selects Freeslate Reaction Screening System to Support New High Throughput Screening Lab 2Health News:Luxury Barber Adds New Regenepure Biotin Conditioner to Their Selection of Grooming Products 2
... By Steven Reinberg HealthDay Reporter , ... are getting their recommended vaccinations, federal health officials reported ... getting the shots increased 15 percent from 2008 to ... and Prevention. "This is the nation,s report card ...
... A medical researcher at the University of Leicester has made ... Dr Paul Symonds from the Department of Cancer Studies ... particular drug in collaboration with radiotherapy gives significantly better results ... of 1,412 patients from 42 different cancer treatment centres which ...
... HealthDay Reporter , THURSDAY, Aug. 19 (HealthDay News) -- ... increase your risk of dying from a stroke or heart ... for men whose blood pressure was at least 168/100, the ... than non-drinkers if they had downed six drinks on one ...
... 19, 2010The first successful report of using cell-depleted lung as ... embryonic stem cells is presented in a breakthrough article in ... by Mary Ann Liebert, Inc. ( www.liebertpub.com ). The article ... stem cells (ESCs) have the potential to mature into virtually ...
... , THURSDAY, Aug. 19 (HealthDay News) -- The economic downturn ... bank accounts aren,t the only things suffering as unemployment remains ... by Mental Health America and other researchers have found that ... for mental illness, especially such conditions as depression and anxiety. ...
... from an international study she was part of indicates ... cancer survivors are outdated. McNeely, from the Faculty ... surgery are often warned that pressure changes in an ... arm. But the study she did with an Australian ...
Cached Medicine News:Health News:More U.S. Teens Get Recommended Vaccines 2Health News:More U.S. Teens Get Recommended Vaccines 3Health News:Significant advance announced in treatment of cervical cancer 2Health News:Binge Drinking, Hypertension a Deadly Combo 2Health News:Binge Drinking, Hypertension a Deadly Combo 3Health News:Natural lung material is promising scaffold for engineering lung tissue using embryonic stem cells 2Health News:Out of Work May Mean Out of Sorts 2Health News:Out of Work May Mean Out of Sorts 3Health News:Breast cancer survivors don't need to be afraid of air travel: U of A study 2
200 L, Racked, Filtered, Pre-sterilized, 96 tips/rack Recommended for 20, 25, 50, 100 and 200 L pipettes. Can also be used with 300 L pipettes when pipetting 200 L or less....
Inquire...
... Finntip Filters are ideal for ... or for any work where ... are designed for pipetting DNA/RNA ... and other. For applications requiring ...
Inquire...
Medicine Products: