GMP Trends and Analyses!

The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance

WRITTEN CONFIRMATIONS: TIME IS RUNNING OUT!

As of 2 July 2013, all active substances imported into the EU need to be accompanied by a Written Confirmation that they were manufactured in accordance with European Good Manufacturing Practices (GMP) or according to equivalent rules. However, many countries outside the EU have not yet commented yet whether - and if yes, when - they will issue these Written Confirmations. Please read more here

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eTACT PROJECT: INTERVIEW WITH DR SUSANNE KEITEL, DIRECTOR OF THE EDQM

The authenticity of medicinal products has to be ensured in order to protect European citizens against falsified products. For that reason industry and regulators are working on appropriate systems to ensure this authenticity - among them the EDQM.  Please read more here

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CLOUD COMPUTING FOR REGULATED "GXP" ENVIRONMENTS - PART ll

During the last 5 years, various service providers developed multiple models for hosting services based on cloud computing. There is a big temptation for regulated organisations to consider such cloud services to reduce operational costs. However such decisions should be taken carefully since data are not only subject to GxP regulation but because they represent one of the most valuable parts of the company's capital. Please read more here

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ECA VALIDATION GOOD PRACTICE GUIDE: A VALUABLE SOURCE OF INFORMATION

Since the US FDA issued the draft of the Validation Guidance in 2008, the issue is no longer to complete three validation runs. It is much more the evidence of process knowledge and understanding. The ECA Good Practice Guide was thus developed to support industry in implementing the new requirements. Please read more here

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THE NEW EU GMP GUIDE ANNEX 2: GOOD THINGS COME TO THOSE…

The tremendous developments and the increasing importance of biopharmaceutical products in the recent years made it necessary to review the EU GMP Guide's Annex 2. Please read more here

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5TH EUROPEAN GMP CONFERENCE DEDICATED TO 50 YEARS OF GMP

GMP is the accepted worldwide "gold standard" for the manufacturing and control of medicinal products. Since its first publication in 1963 by the US FDA these Good Manufacturing Practices have been developed tremendously. These developments and how a harmonisation of GMP regulations could be promoted will be discussed during this conference. Please read more here

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THE CHALLENGE OF DEVIATION MANAGEMENT

Whenever an unplanned event results in a deviation, it must be handled accordingly. And the appropriate handling of these deviations presuppose a clear understanding of the steps involved in managing them. Please read more here

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THE STANDARD DIN ISO 14644-1:1999: PROGRESS OF THE REVISION

The fundamental standard for cleanrooms is the ISO 14644-1:1999. Following the publication of a new international draft of the standard in 2010 the respective ISO committee received lots of comments - making some significant changes in the draft very likely. Please read more here

 

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CLOUD COMPUTING FOR REGULATED "GXP" ENVIRONMENTS - PART 1

During the last 5 years, various service providers developed multiple models for hosting services based on cloud computing. There is a big temptation for regulated organisations to consider such cloud services to reduce operational costs. However such decisions should be taken carefully since data are not only subject to GxP regulation but because they represent one of the most valuable parts of the company's capital. Please read more here

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cGMP COMPLIANCE QUESTIONS TO AUTHORITY REPRESENTATIVES AND INDUSTRY EXPERTS.

During courses and conferences authority representatives and industry experts regularly answer questions from attendees - in this issue with respect to Annex 11. Please read more here

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