Month: October 2014

ABBREVIATED NEW DRUG APPLICATION (ANDA) by Anthony crasto

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ABBREVIATED NEW DRUG APPLICATION (ANDA) by Anthony crasto

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System Suitability for USP Chromatographic Methods

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System Suitability for USP Chromatographic Methods
How should system suitability tests (SSTs) be structured for USP monographs? More about USP experts group’s recommendations on the parameters and acceptance criteria for SSTs and the essential aspects of this new approach can be found in this News.

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http://www.gmp-compliance.org/enews_4539_System-Suitability-for-USP-Chromatographic-Methods_9150,8369,8488,Z-QCM_n.html

An interesting article from the USP experts group “Small Molecules” has been published in the Pharmacopoeial Forum 39(5). It deals with USP’s future requirements regarding system suitability tests (SST).

SSTs are performed each time an analytical method is used. Together with instruments qualification and methods validation, the SST ensures the quality of analytical test results. The SST shows that a procedure and an instrumental system are performing as they did when the procedure was validated and that the method is thus “fit for purpose” for the intended use.

General requirements can be found in the USP Chapter <621> Chromatography which also contains provisions and acceptance criteria for individual parameters of the SST. Nevertheless, parameters and acceptance criteria laid down in specific monographs always take priority over the general provisions provided in General Chapter <621>.

In the article, the USP Expert Committee has noted that because of many different sponsors who have submitted a number of various monographs to the USP, inconsistencies with regard to SSTs in the USP have arisen.

That’s why the USP Expert Committee has described in this article which data are required on SSTs for new monographs or monographs to be updated. The following descriptions are provided:

  • Assay
  • Impurities
  • Dissolution
  • Content Uniformity

You can find all information on the USP website of the Pharmacopeial Forums (PF).

Source: USP

NEWDRUGAPPROVALS Touches 4 lakh views in 198 countries

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New Drug Approvals

Inline image 1

NEW DRUG APPROVALS

ALL ABOUT DRUGS, LIVE, BY DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER, HELPING MILLIONS, 7 MILLION HITS ON GOOGLE, PUSHING BOUNDARIES, ONE LAKH PLUS CONNECTIONS WORLDWIDE, 4 LAKHS PLUS VIEWS ON THIS BLOG IN 198 COUNTRIES

ANTHONY MELVIN CRASTO

THANKS AND REGARD’S
DR ANTHONY MELVIN CRASTO Ph.D

amcrasto@gmail.com

MOBILE-+91 9323115463
GLENMARK SCIENTIST ,  INDIA

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Final Concept Paper ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle

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Final Concept Paper ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle
Currently, there are no harmonised approaches to technical and regulatory considerations for the lifecycle management of pharmaceutical products. Therefore, ICH has just published a Final Concept Paper for a new ICH Q12 Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle. The proposed ICH Guideline is intended to fill this gap. read

http://www.gmp-compliance.org/enews_4533_Final-Concept-Paper-ICH-Q12-Technical-and-Regulatory-Considerations-for-Pharmaceutical-Product-Lifecycle_8348,8360,Z-PDM_n.html

ICH has just published a Final Concept Paper for a new ICH Q12 guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle.

Currently, there is a lack of a harmonised approach to technical and regulatory considerations for the lifecycle management of pharmaceutical products. Although there are concepts in ICH Q8, Q9, Q10 and Q11 for a more science and risk-based approach for assessing changes across the lifecycle, several gaps exist which hinder a full realization of the benefits intended. The original aim of ‘operational flexibility’ in post-approval changes has not been achieved yet. The main focus at ICH to date is on early stages of the product lifecycle, especially on development and launch.

A similar focus is now needed for the commercial manufacturing phase in order to fill these gaps. Furthermore, there is an inconsistent utilization of post-approval change management plans and comparability protocols. The pharmaceutical industry needs a more strategic manner to prospectively manage future changes.

The proposed ICH Q12 Guideline is intended to work with ICH Q8 to Q11 Guidelines and will provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. This guideline will promote innovation and continual improvement, and will allow regulators (assessors and inspectors) to better understand post-approval CMC changes.

The new ICH Q12 guideline will foster a more efficient regulatory evaluation, both in review and inspection, and will address these topics:

  • Regulatory Dossier
    – Reducing the appropriate level of detail and information necessary for regulatory assessment and inspection in the dossier,
    – Post approval changes that facilitate continual improvement and encourage the adoption of innovative technologies.
  •  Pharmaceutical Quality System aspects (ICH Q10)
    – A risk-based change management system for changes,
    – Need for a knowledge management system over the product lifecycle.
  •  Post-Approval Change Management Plans and Protocols
    – Concept of a post-approval management plan including the assessment by regulatory authorities (assessors and inspectors)
    – Enhanced product development and control strategy approaches (Quality by Design (QbD) providing opportunities for scientific and risk based foundations for post-approval change management plans).

This lifecycle management guidance will also support the implementation of innovative technologies such as Process Analytical Technology (PAT) and Continuous Manufacturing, and will also facilitate “operational flexibility”.

For further information please see the complete Concept Paper ICH Q12 as well as the Business Plan

Nabriva’s lefamulin, BC 3781 receives FDA fast-track status to treat CABP and ABSSSI

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New Drug Approvals

2D chemical structure of 1061872-97-6

Nabriva’s lefamulin receives FDA fast-track status to treat CABP and ABSSS
Austria-based Nabriva Therapeutics has received qualified infectious disease product (QIDP) and fast-track status designation from the US Food and Drug Administration for its lefamulin (BC 3781).

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http://www.pharmaceutical-technology.com/news/newsnabrivas-lefamulin-receives-fda-fast-track-status-to-treat-cabp-and-absssi-4399182?WT.mc_id=DN_News

Antibiotics 02 00500 i025

BC-3781

Topical pleuromutilin antibiotic agent

Gram-positive, including MRSA, PHASE 2 COMPLETED,Infection, acute bacterial skin and skin structure (ABSSSI)

Nabriva (Austria), Nabriva Therapeutics AG

BC-3781

cas 1061872-97-6

UNII-61H04Z5F9K

(3aS,4R,5S,6S,8R,9R,9aR,10R)-5-Hydroxy-4,6,9,10-tetramethyl-1-oxo-6-vinyldecahydro-3a,9-propanocyclopenta[8]annulen-8-yl [[(1R,2R,4R)-4-amino-2-hydroxycyclohexyl]sulfanyl]acetate;

14-O-[2-[(1R,2R,4R)-4-Amino-2-hydroxycyclohexylsulfanyl]acetyl]mutilin

BC-3781 is a pleuromutilin antibiotic in early clinical development at Nabriva for the treatment of community acquired pneumonia and for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Pleuromutilin antibiotics interfere with bacterial protein synthesis via a specific interaction with the 23S rRNA of the 50S bacterial ribosome subunit. They have a distinct antibacterial profile and show no cross-resistance with any other class of antibiotics. In 2012, a codevelopment agreement was signed between Forest and Nabriva…

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