GMP NEWS 2010

New Best Practice Guides for the Submission and Processing of Variations published

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human has updated the Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Find further information here.

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Outcome of the survey to the new EU GMP-Guideline Chapter 1

Last year the European Commission has released the draft Chapter 1 Quality Management System of the EU Guidelines to GMP for public consultation. In order to get some broad feedback, the ECA decided to conduct a survey among its members. Outcome of the survey.

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Discussion of the EU Pharma Package in the European Council of Ministers

The EC pharma package meant to combat counterfeit medicinal products and amending Directive 2001/83/EC has now been discussed in the European Council of Ministers. Find the details here.

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New Template for Drug API Quality Agreements

The Bulk Pharmaceuticals Task Force (BPTF)* has developed and published a Quality Agreement template. Read more.

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FDA Inspections in China - Consequences from the Heparin Case

The USA is still systematically evaluating the experience in the Heparin case. More precisely this means that the former FDA inspections at Heparin manufacturers in China were analysed. Read more here.

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Warning Letter Analysis for Process Validation

Because the US GMP Regulations do not address Process Validation in an own paragraph, it is not easy to immediately catch deficiencies in this area in Warning Letters issued by the FDA. For that reason you will find a detailed analysis for process validation deficiencies for the fiscal year 2009 here.

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Database "QPSHARE" for Planning Joint Audits Already Used Intensively

Recently, the European Qualified Person Association made the database "QPSHARE" accessible to its members, which enables QPs to increase the efficienvcy of the supplier qualification of their companies. The database is already used intensively. Read more here.

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Why Are There More and More Serious GMP Deficiencies on the Basis of Inspections?

The number of serious GMP deviations identified during inspections is growing. But what is the reason for this? Have the firms really become "worse"? Read more here.

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Revised EMA Paper Specifies Requirements on Preparation, Conduct and Follow-Up of Official Inspections

A revised EMA paper specifies requirements on the preparation, conduct and follow-up of official inspections. In the sense of a changed perspective, the document is also worth reading for manufacturers of medicinal products, investigational medicinal products and active pharmaceutical ingredients. Read more.

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Webinar with FDA's John Murray on Software Validation in the Field of Medical Devices

Webinars are an efficient method for imparting information. A recent webinar with John Murray, FDA, is now available. Here you can read more.

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FDA answers questions to ICH Q8, Q9, and Q10

The FDA has published a new Guidance for Industry: Q8, Q9, and Q10 Questions and Answers reflecting the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances. Summary

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EFPIA Publishes Results of the Track & Trace Project

In April, the EFPIA published the report about the pilot project on the tracing and verification of medicinal products in Sweden. Read more.

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Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC

Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC: summary of responses to the public consultation paper published. Read more.

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EDQM initiates survey about the production of Water for Injection (WFI)

Currently, the European Pharmacopoeia only allows distillation for the production of Water for Injection (WFI). The EDQM has initiated a survey through industry associations to gather suitable information and data. You will find more here.

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Further CEPs suspended and withdrawn by EDQM

The EDQM continues to inspect manufacuturers of APIs - especially in Asia. As a consequence further CEPs were suspended or withdrawn. You will find more information here.

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Shared Audits: How Can You Find Partners in Order to Share Audit Costs?

'Shared audits' are on everyone's lips. The term describes the fact that several firms hold a joint audit of the same supplier. Such a procedure can reduce the costs considerably. Read here how this can be done and what has to be taken into account.

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FDA Finalises Guidance on the Standardisation of the Numerical Identification for Medicinal Products

In March, the FDA published the final version of its guidance on the standardised numerical identification for prescription medicinal products. Read more.

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FAQs on the EMA-FDA GCP Initiative published

The EMA and the FDA have published a set of Q&As on their new GCP-Initiative. Read more.

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Public Consultation on Annex 2 started

The European Commission published the revised Draft of Annex 2 "Manufacture of Biological Medicinal Substances and Products for Human Use" for the second pubic consultation with deadline for comments 15th July 2010. More details can be found here.

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New FDA - NIH Initiative on a Formulations Framework for paediatric Drugs

A collaborative initiative between the FDA and the National Institute of Health is currently being developed to define a formulations framework for drugs that are used in pediatric patients. Read more.

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