New Questions in the RMM Discussion Forum

The ECA RMM Working Group online discussion forum comprises some new questions of group members. For more information please go here.


FDA Plans New Part 11 Inspections

The topic of electronic records / electronic signatures is again on the FDA's current agenda. On 8 July 2010, the Agency announced that it would increasingly focus on the implementation of the 21 CFR Part 11 requirements during upcoming inspections. Read more here.


Revision of EP chapter 5.1.6. Alternative Methods for Control of Microbiological Quality

European Pharmacopoiea: The Modern Microbiological Methods Working Party published a questionnaire to the revision of Chapter 5.1.6 “Alternative Methods for Control of Microbiological Quality Rapid Microbiological Methods. More details can be found here.


Revised Annex 13 on Investigational Medicinal Products (IMP) coming into operation

The European Commission has published on the EudraLex - Volume 4 webpage the new Annex 13 (Investigational Medicinal Products) of the EU Guidelines to Good Manufacturing Practice. The new Annex is coming into force in July 2010. Read what's new.


Part 2 EU GMP Guide on APIs Will No Longer Be Identical to ICH Q7

The European Commission published a revised Part 2 text on GMP for APIs which will enter into force by 31 July 2010. Click here to read more.


The New Role of PAT as an Integral Part of QbD

According to Ken Leiper, member of the Steering Committee of the University of Heidelberg QbD / PAT Conference 2010, PAT and QbD are not mutually exclusive but they are complementary. Read more here.


EMA Draft Guideline open for Comments: Guideline on Quality Aspects on the Isolation of Candidate Influenza Vaccine Viruses in Cell Culture

To provide guidance  to manufactueres of influenza vaccines on the quality issues associated with isolating candidate vaccine viruses in cell culture, the EMA lays down the quality recommendations for cells used to isolate candidate influenza vaccine viruses in a new draft guideline, which is open for consultation until September 2010. More information can be found here.


FDA Plans to Revise cGMP Guide Focussing on Outsourcing and Raw Materials

The FDA is going to revise 21 CFR 210/211 as part of their initiative to update cGMP requirements in a stepwise approach. Click here to read more


FDA Publishes Draft Guidance on Third-Party Audits of Medical Device Manufacturers

The FDA announces the draft of a guidance for medical device manufacturers aiming at including audit results according to ISO 13485 into a risk-based working programme by the FDA. One of the objectives is a reduction in FDA inspections. Read more here.


News on Turkey's Tracking & Tracing System

The current state of Turkey's serialisation system and upcoming milestones on the timeline were presented at the second ECA Tracking & Tracing Conference in Stockholm on 16-17 June 2010. Read more.


Clinical Trials: new Document for public Consultation

The European Commission has published a public consultation document: Draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use ('CT-3'). Read more. 


New Documents by CMD(h) on "Unforeseen Variations"

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has published two documents on unforeseen variations. Read more here.


Comprehensive Study about Verification of GMP Compliance at API Manufacturers published by DMA

On 20 May 2010 the Danish Medicines Agency (DMA) published results of a survey to examine the extent to which manufactureres of medicinal products comply with their obligation to ensure that APIs used in the manufacture of medicinal products comply with the GMP regulations. A number of deficiencies have been identified which need to be remedied in the future. You will find more here.


Clinical Trials: FDA proposes new Data Falsification Rule

The FDA proposed an updated regulation to require sponsors to report information pertaining to any individual that has or may have engaged in falsification of data in clinical trial studies involving human or animal subjects. Read more.


European Commission Decides to Establish a European Database for Medical Devices (Eudamed)

The European Commission has decided to establish a European database for medical devices (Eudamed) in order to be able to access safety-relevant data more quickly. Furthermore, it will help to facilitate the registration procedure for IVDs. Read more here.


FDA Guideline to Reduce the Risk of Transmission of CJD and vCJD by Blood and Blood Products

In May, FDA published the new Guidance for Industry "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products". More information can be found here.


Regulation amending the REACH Annexes relevant for SDS (Safety Data Sheet)

The Commission has adopted a Regulation amending the REACH Annexes relevant for SDS – Annex II and, to a lesser extent, Annex VI. Click here to read more.


Revised Q&A Document available in EudraLex Volume 10 - Clinical Trials

The "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. The revised version 6.0 of this document is available here.


EMA publishes Reflection Paper on ethical and GCP Aspects of Clinical Trials conducted in third Countries

The European Medicines Agency has published for public consultation a reflection paper on ethical and GCP aspects of clinical trials conducted in third countries for evaluation in marketing authorisation applications for medicines for human use, submitted to the EMA. Read more.


USP seeks Submission of Proposals for Monograph Modernization

USP is seeking submission of proposals to support the modernization of USP-NF small molecule and excipient monographs that utilize outdated technology (e.g., use of packed gas chromatography columns), have safety/environmental concerns (e.g., chlorinated solvents, etc) or are missing procedures for key aspects such as impurities. Click here to read more.


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