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

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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.



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

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.,S-WKS_n.html

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


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.,S-WKS_n.html


Genzyme’s multiple sclerosis treatment approved by European Commission

New Drug Approvals

Sanofi and its subsidiary Genzyme have been given marketing approval by the European Commission for Lemtrada (alemtuzumab), a treatment for multiple sclerosis.  read all at

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Genzyme’s multiple sclerosis treatment approved by European Commission

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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,

New Drug Approvals



  • 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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A significant number of new specialty medications are on track to be approved in 2013, and some will provide increased competition in certain therapy classes.

New Drug Approvals


read all at


Aimee Tharaldson, PharmD, is a senior clinical consultant in the emerging therapeutics department at Express Scripts. She is responsible for monitoring and analyzing the specialty pharmaceutical pipeline. The emerging therapeutics department produces several proprietary reports on the pipeline for use by Express Scripts’ employees and clients. It is also responsible for the safety program that alerts patients, physicians, and clients to important information regarding serious drug safety alerts and market withdrawals. She contributes to Express Scripts’ Drug Trend Report and plays a key role in developing and maintaining Express Scripts’ specialty drug list. She received her doctor of pharmacy degree from the University of Minnesota, College of Pharmacy, and completed a pharmacy practice residency at the Minneapolis VA Medical Center. –


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Sanofi to withdraw the lixisenatide New Drug Application (NDA) in the U.S., The company plans to resubmit the NDA in 2015, after completion of the ELIXA CV study.

New Drug Approvals


Sanofi Provides Update on Lixisenatide New Drug Application in U.S.

Paris, France – September 12, 2013 – Sanofi (EURONEXT: SAN and NYSE: SNY) announced today its decision to withdraw the lixisenatide New Drug Application (NDA) in the U.S., which included early interim results from the ongoing ELIXA cardiovascular (CV) outcomes study. The company plans to resubmit the NDA in 2015, after completion of the ELIXA CV study.

The decision to withdraw the lixisenatide application follows discussions with the U.S. Food and Drug Administration (FDA) regarding its proposed process for the review of interim data. Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA study. Sanofi’s decision is not related to safety issues or deficiencies in the NDA………………………read all at



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“5TH PHARMACOVIGILANCE CONGREGATION 2013–20th November 2013, Kohinoor Continental Hotel, Mumbai, India.



“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”

20th November 2013, Kohinoor Continental Hotel, Mumbai, India.

Greetings from Virtue Insight,

I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “5th Pharmacovigilance Congregation 2013” The conference will be held on 20th November 2013, Kohinoor Continental Hotel, Mumbai, India.


  • Deepa Arora, Global Head, Drug Safety & Risk Management, Lupin
  • Arun Bhatt, President, Clininvent Research
  • Moin Don, Executive Director, PVCON Pharmacovigilance Auditing & Consulting Services
  • Bhaswat Chakraborty, Senior Vice President, Research & Development, Cadila Pharmaceuticals
  • Parminder Kaur, Owner & Regulatory Affairs & PhV Consultant (QPPV), RegPak BioPharma Consulting (Netherlands, UK)
  • Babita Kirodian, Head – Pharmacovigilance, Bristol-Myers Squibb
  • Rajani Rokade, Head – Pharmacovigilance, Sanofi Aventis
  • Veena Rajan, Head – Patient Safety, AstraZeneca
  • Sofi Joseph, Head – Regulatory Operations, Pfizer
  • Manish Mistry, Medical Director, Novartis
  • Abhay Chimankar, Global Safety Officer, Cipla
  • Girish Parhate, Senior Manager – Regulatory Affairs, Bayer
  • Indu Nambiar, Clinical Safety Officer, Boehringer Ingelheim
  • Prashant Bodhe, Director, CliniSearch
  • Deepti Sanghavi, Senior Medical Writer – Medical Writing, SIRO Clinpharm
  • Milind Antani, Head – Pharma LifeSciences group, Nishith Desai Associates
  • Anish Desai, Director Medical Affairs and Clinical Operations, Johnson & Johnson

And many more…

TARGET AUDIENCE – INDUSTRY:- Vice Presidents, Directors, CRO’s, Heads and Managers of:- Pharmacovigilance Strategy, Drug Safety/Risk Management, Information and Clinical Data Management, Clinical Research, Research & Development, Product Safety/Assurance Assessment , Patient Safety & Outcomes Research & Data Analysis, Epidemiology project management, Regulatory Affairs and Compliance, Sales & Marketing, Biotech manufacturers and many more…

Should you have any questions, or to receive the updated event brochure or sponsorship details, please let me know don’t delay! Secure your place today by calling me on +91 9171350244, Email –,


•        Early Bird Discounted Price – Conference Delegate Pass (INR 4,000 + Tax (12.36%) per delegate) – Book and Pay before 07th October 2013 to avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9171350244. Email –,

•        Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 5,000 + Tax (12.36%) per delegate) – You can simply email or call and book your conference delegate seats on TEL: +91 9171350244. Email –

•        Group Discounts – 3 and above Delegates – (INR 4,000 + Tax (12.36%) per delegate)

•        Spot Registration – (INR 6,000 + Tax (12.36%) per delegate)

•        Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to –TEL: +91 9171350244. Email –,

We also have some sponsorship opportunities available for the event which gives you an opportunity to speak/exhibit and create brand awareness. In addition, the networking opportunities in focused and relevant industry gathering provide the personal contact necessary for business development efforts.

In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.

PLS: – Please forward this email to anyone you think may benefit from it.

Thank you for your time and consideration. I look forward to hearing from you.

Deepak Raj

Delegate & Sponsorship Sales

Virtue Insight

Gsm –   + 91 9171350244;

Tel –       + 91 44 65515693;

E Mail –

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5th Annual Pharmacovigilance 2013....pdf 5th Annual Pharmacovigilance 2013….pdf
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Sun, Reddys, Bharat Biotech, 3 Indian Companies among Best Company in an Emerging market–Scrip Awards 2013

New Drug Approvals


Shortlist for the SCRIP Awards 2013.

Deciding on a shortlist from so many deserving entries was never going to be an easy process for our independent judging panel, but they rose to the challenge and this list represents the best of the best.

Best Company in an Emerging Market – Sponsored by Clinigen Group

  • Bharat Biotech – India
  • Dr Reddy’s Laboratories – India
  • Sphaera Pharma – Singapore
  • Sun Pharmaceutical Industries – India
  • WuXi AppTec – China

Best Technological Development in Clinical Trials

  • ArisGlobal’s Total Clinical
  • Covance’s Xcellerate
  • ICON’s ICONIK Monitoring for Patient Safety
  • INC Research’s Trusted Process
  • PPD’s real-time data offering
  • Quintiles’ Infosario Safety

Best Partnership Alliance

  • AstraZeneca with Bristol-Myers Squibb and Amylin in diabetes
  • AstraZeneca and LegoChem to develop two compounds as a combination antibacterial
  • for The Investigator Databank with Janssen R&D, Eli Lilly, Merck & Co and Pfizer
  • Roche with Isis Pharmaceuticals for antisense drugs…

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