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Guideline on the European Drug Master File Procedure updated

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Guideline on the European Drug Master File Procedure updated

http://www.gmp-compliance.org/ecanl_619_0_news_3750_7935,S-RGL_n.html

The “Guideline on Active Substance Master File Procedure” which was developed by EMA’s Quality Woring Party, describes the procedure that can be used to document an API’s quality for a regulatory authority. This guideline was already revised several times since it was initially issued in 2006. The last update was published in October 2012. This 3rd revision was updated again now to “support the Working Group on Active Substance Master File Procedures in their initiatives to improve the ASMF procedure across the European Regulatory Network” as mentioned in the remarks on page 2 of the Guideline.

The Guideline comprises updates mainly referring to its Annexes:

  • Annex 1: In part 3.2.S.2.1 of the ASMF all sites where manufacturings steps (e.g. the manufacturing of intermediates, quality controls, in-process controls, milling and sterilisation processes) take place have to be indicated.
  • Annex 2: With this Letter of Access the API manufacturer (ASMF Holder) grants the authority insight into the ASMF’s restricted part. According to the respective passage which was included in the letter template, the API manufacturer agrees that the authority exchanges the ASMF evaluation reports with the EDQM’s certification department.
  • Annex 3: This “Submission Letter and Administrative Details for documents relating to an ASMF” has to be submitted together with the ASMF as part of a new marketing authorisation application or a variation. The updated template of this letter comprises much more detailed requirements. For instance, the active substance (where applicable) has to be specified regarding its salt form, water content and grade.
  • Annex 4: Withdrawal of Access Letter. With this letter the ASMF Holder can withdraw the authorisation for the authority to use the ASMF (restricted part). The reasons for this can be the termination of API manufacture or the replacement of the ASMF procedure by the CEP procedure (CEP = Certificate of Suitability). This Annex is new.
  • The Annexes 5, 6 and 7 (previously Annexes 4 and 5) were modified only slightly. The glossary (Annex 7) includes references to the respective VICH GL39-Guideline which is based on ICH Q6A.

The Guideline text itself was adapted according to the updated Annexes.

Please see the “Guideline on Active Substance Master File Procedure”; CHMP/QWP/227/02 Rev 3/Corr” for more detailed information.

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FDA’s Portal To India

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Regulatory Compliance Digest

SacksOfSpicesA cursory look in our kitchens confirms the fact that it is indeed a small world after all.  Those of us living in the U.S. take know that as part of our daily routines, including the foods we consume.  India is a case in point.

According to the U.S. Commerce Department, nearly one quarter of the spices, oils and food colorings used in the U.S. comes from India.  Overall, in 2011, India was the second largest drug exporter and the seventh largest food exporter to the U.S.

It makes sense then that a high-level U.S. agency plays a prominent role in coordinating the interests of Americans in this ever-expanding global village.  As part of its broader regulatory functions, the U.S. Food and Drug Administration (FDA) works to ensure that foreign-produced foods and drugs are safe, effective and of good quality.

FDA Collaboration with India

As part of its response…

View original post 453 more words

FDA’s Portal To India

Posted on

Regulatory Compliance Digest

SacksOfSpicesA cursory look in our kitchens confirms the fact that it is indeed a small world after all.  Those of us living in the U.S. take know that as part of our daily routines, including the foods we consume.  India is a case in point.

According to the U.S. Commerce Department, nearly one quarter of the spices, oils and food colorings used in the U.S. comes from India.  Overall, in 2011, India was the second largest drug exporter and the seventh largest food exporter to the U.S.

It makes sense then that a high-level U.S. agency plays a prominent role in coordinating the interests of Americans in this ever-expanding global village.  As part of its broader regulatory functions, the U.S. Food and Drug Administration (FDA) works to ensure that foreign-produced foods and drugs are safe, effective and of good quality.

FDA Collaboration with India

As part of its response…

View original post 453 more words

FDA’s Portal To India

Posted on

Regulatory Compliance Digest

SacksOfSpicesA cursory look in our kitchens confirms the fact that it is indeed a small world after all.  Those of us living in the U.S. take know that as part of our daily routines, including the foods we consume.  India is a case in point.

According to the U.S. Commerce Department, nearly one quarter of the spices, oils and food colorings used in the U.S. comes from India.  Overall, in 2011, India was the second largest drug exporter and the seventh largest food exporter to the U.S.

It makes sense then that a high-level U.S. agency plays a prominent role in coordinating the interests of Americans in this ever-expanding global village.  As part of its broader regulatory functions, the U.S. Food and Drug Administration (FDA) works to ensure that foreign-produced foods and drugs are safe, effective and of good quality.

FDA Collaboration with India

As part of its response…

View original post 453 more words

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

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Quality means fitness for intended use. Pharmaceutical quality refers to product free of contamination and reproducibly delivers the therapeutic benefit promised in the label to the consumer. The Quality of the pharmaceutical product can be evaluated by in vivo or in vitro performance tests. Quality by design assures in vitro product performance and In vitro product performance provides assurance of in vivo product performance. “Hence Quality by design relate to Product Performance”.

see all at

http://www.askaboutvalidation.com/pharmaceutical-quality-by-design-qbd-an-introduction-process-development-and-applications/

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

Author-Mr. UMESH PATIL. Pursuing Master of Pharmacy (PHARMACEUTICS), KLE Society’s College of Pharmacy, Hubli. Karnataka.

Forest Announces U.S. Availability of New Once-Daily NAMENDA XR

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New Drug Approvals

 

memantine

Forest Announces U.S. Availability of New Once-Daily NAMENDA XR

— Treatment for moderate to severe Alzheimer’s Disease is now available to patients in a convenient extended release formulation —

NYSE:FRX.NEW YORK–(BUSINESS WIRE)–Forest Laboratories, Inc. announced today that NAMENDA XR(TM) (memantine hydrochloride) once-daily formulation is now available in pharmacies throughout the United States. NAMENDA XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe dementia of the Alzheimer’s type.

http://www.pharmalive.com/once-daily-namenda-xr-launched-in-us

Memantine is the first in a novel class of Alzheimer’s disease medications acting on theglutamatergic system by blocking NMDA-type glutamate receptors. It was first synthesized by Eli Lilly and Company in 1968. Memantine is marketed under the brandsAxura and Akatinol by MerzNamenda by ForestEbixa and Abixa by Lundbeck andMemox by Unipharm. Memantine has been shown to have a modest effect in moderate-to-severe Alzheimer’s…

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