Month: September 2013

Six Ways To Optimize Your Quality Management System And Ensure FDA And ISO Compliance

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Source: MasterControlmastercontrol-logo.jpg

How much does quality cost? Most companies would be hard-pressed to translate “quality” into dollars and cents. What they realize, however, is that a lack of quality could cost millions of dollars in rework, scrap, recall, or even liability lawsuits.

This is especially true in the strict FDA and ISO environments, where quality is closely incorporated in regulations and standards. The FDA explicitly states that the overarching philosophy of the Current Good Manufacturing Practice (CGMP) Regulations is this: Quality should be built into the product, and testing alone cannot be relied to ensure product quality. Similarly, the eight quality management principles that form the basis of the ISO 9000 series of standards articulate the importance of making quality an integral part of a manufacturer’s daily operations.

Six Ways for Optimization
This white paper posits that an optimal quality management system is the foundation for long-term regulatory compliance, and consequently, for enduring market success. Without a solid quality infrastructure, your organization is simply not equipped to face the challenges of the regulatory environment and the vicissitudes of a competitive market. In addition, an optimal system will spare you the unnecessary, and often staggering, cost of poor quality.

MasterControl Inc., a leading provider of quality management software solutions for companies in the FDA and ISO sectors, offers the following tips for optimizing your quality management system to ensure high-quality products/services and continuous compliance.

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EMCURE-A SUCESS STORY

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New Drug Approvals

Mukund K Gurjar

Chief Scientific Officer, Director of Research & Development and Executive Director, Emcure Pharmaceuticals
Emcure Pharmaceuticals Limited
ITBT Park Phase II
Hinjwadi, PUNE, INDIA

Among the vast ocean of literature on organic chemistry , you will find a pearl in the form of Emcure

we are treated to excellent reading material and important communications in our field

hats off to this team

Dr. Mukund K. Gurjar serves as the Chief Scientific Officer of Emcure Pharmaceuticals Limited and serves as its Director of Research & Development.

Dr. Gurjar has been closely associated with Drugs and Pharmaceutical Sciences since 1975 and is a distinguished Researcher in the country. He has carried out extensive work in the field of new chemical entities (NCEs). Dr. Gurjar has been an Executive Director of Emcure Pharmaceuticals Ltd. since 2001.

He serves as Deputy Director at National Chemical Laboratory, Pune. Dr. Gurjar served as Non-Executive Director…

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WHO publishes revised draft on GTDP for pharmaceutical starting material

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WHO publishes revised draft on GTDP for pharmaceutical starting material

The WHO has published a proposal to revise the Good Trade and Distribuiton Practices for Pharmaceutical Starting Materials. Read more.

http://www.gmp-compliance.org/ecanl_632_0_news_3868_7914,S-WKS_n.html

EMA publishes revised dossier-submission requirements for active-substance master files

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The European Medicines Agency has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file (ASMF) dossiers as part of human or veterinary marketing-authorisation or variation applications. Go here to read more.

http://www.gmp-compliance.org/ecanl_632_0_news_3914_7935,S-WKS_n.html

 

The first generic version of the oral chemotherapy drug Xeloda (capecitabine) has been approved by the U.S. Food and Drug Administration to treat cancers of the colon/rectum or breast,

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New Drug Approvals

capecitabine

154361-50-9

  • R-340, Ro-09-1978, Xeloda

pentyl [1-(3,4-dihydroxy-5-methyltetrahydrofuran-2-yl)-5-fluoro-2-oxo-1H-pyrimidin-4-yl]carbamate

MONDAY Sept. 16, 2013 — The first generic version of the oral chemotherapy drug Xeloda (capecitabine) has been approved by the U.S. Food and Drug Administration to treat cancers of the colon/rectum or breast, the agency said Monday in a news release.

This year, an estimated 142,820 people will be diagnosed with cancer of the colon/rectum, and 50,830 are predicted to die from the disease, the FDA said, citing the U.S. National Cancer Institute. An estimated 232,340 women will be diagnosed with cancer of the breast this year, and some 39,620 will die from it.

The most common side effects of the drug are diarrhea, vomiting; pain, redness, swelling or sores in the mouth; fever and infection, the FDA said.

The agency stressed that approved generics have the same high quality and strength as their brand-name counterparts.

License to produce the…

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