Noor's Pharmaceutical Home

Pharmaceutical  News

(Regulatory)

 

February 2010

 

CEP News

• Updated application forms for New applications and Revisions/Renewals

  • New CEP

  • Revision of CEP

Lab Compliance News

• FDA Launches a new Risk-Assessment Tool for Better Drug and Food Import Control

• ICP Systems for Metal Impurity Analysis Must be Part 11 Compliant

• USP Changes Dissolution Performance Verification Tests

• OOS of Stability Chambers not Investigated" Draws FDA Warning Letter

• FDA Publishes New Guidance for Calibration of Dissolution Apparatus

• FDA Warning for Data Manipulation

 

GMP News

• European Medicines Agency develops European Network of Paediatric Research

• Genotoxicity Research - New HMPC Guideline for Herbal Medicinal Products

• Inspection Results of the MHRA Published

  •  Presentation

• PQR and Management Review: Increasing Importance

  • New Draft on Chapter 1 of the EU GMP Guide

• Q&A Document on Variations Regulation published

  •  Document

• European QP Association To Release the Database "QPSHARE" Soon

• Warning Letters Report 2009 - Increasing number of Warning Letters

• FDA Guidance on "Mechanical Calibration of Dissolution Apparatus" Passed

• EDQM announces new System for Revision/Renewal of CEP Certificates

• Recall of USP 33 - NF 28

• EU commission finally issues Guidance on new variation rule

• Inspection results on Investigational Medicinal Products Published

• EMA update on dedicated Facilities

  •  Concept Paper

• Overview of New and withdrawn FDA guidances 2009

  •  Withdrawn List, Complete list

• EC Commission Publishes Draft on the Creation of a Site Master File

• New CAPA Guidance Published

  •  Guidance

• Current Status of the Counterfeit Directive in the EU Parliament

• Recent Changes Concerning the USP Dissolution Performance Verification Test

 

USP News

• New Draft Pending Standard for the month of February

  •  Presentation

• Calculation Tool for the Performance Verification Test (PVT) of Dissolution Assemblies

• Performance of Equipment to Test Dissolution of Medications Further Assured

 

January 2010

CEP News

•  New system for Revision/Renewal of certificates

• Guideline on revision/renewal of CEP

• Procedures for management of revisions/renewals of CEP

 

Lab Compliance News

• A Vendor's Statement not Enough Evidence for Software Validation

• USP Proposes three new Chapters for Heavy Metal Impurity Analysis

• Not Putting Finished Drugs on Accelerated Stability Studies Draws FDA Warning

• Using Changed Software before Revalidation Cited in FDA Warning Letter

• New Audio Seminars in 2010 - Schedule Available

 

GMP News

• PIC/S publishes Example of Methodology for the Implementation of Quality Risk Management (QRM) in pharmaceutical Industry

• European Commission Publishes Proposal for Part 3 to the EC GMP Guide

• FDA Publishes Statement on the Frequency of Media Fills

• The APIC Publishes Templates for Quality Agreements

• European Commission Publishes Proposal for Part 3 to the EC GMP Guide

• EDQM Announces the Suspension of Further CEPs

• Revision of EU GMP Guide Chapter 1 Published

• When Will the New Variations Regulation Come into Operation?

• Riboflavin Test for Cleaning Validation - Standardisation regarding Information Sheet of VDMA

• Interpretation of the New Annex 1 to the EC GMP Guide by PIC/S

 

USP News

• Revision Bulletins

• USP pending monographs

• USP seeks comments on proposed revisions to General Chapter <1163> Quality Assurance in Pharmaceutical Compounding

• USP has recalled USP 33–NF 28 because of text errors and intends to reissue the publication in March 2010. Information about the recall is available in two public notices released on

  • January 8, 2010

  • January 12, 2010.

• New and Revised General Chapter <797> FAQs