GMP NEWS 2014

Uniform Blood and Blood Component Container Labels

After a request of the International Council for Commonality in Blood Banking Automation, the FDA published a Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels. Get more details.

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Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

Related to the necessary assessment of environmental impacts, the FDA published a Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products. Read more here.

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EDQM updates Guideline on the "Requirements for revision/renewal of CEPs"

CEP holders have to consider new regulations when notifying changes to submitted application documents. Concerning this, the EDQM updated the corresponding guideline. Read more here.

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FDA defines Goal Dates for the Processing of Changes in Generics Authorisation Applications

The FDA is committed to compliance with certain deadlines for the processing of change applications and amendments in the approval process for generic drugs. Two recently published "Guidances for Industry" provide some information. Read more.

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PIC/S adopts EU GDP Guidelines

The Pharmaceutical Inspection Co-operation Scheme PIC/S has published a PIC/S Guide to GDP. This Guide is based on the EU GDP-Guidelines (2013/C 343/01) and quotes the EU Guide almost completely. Read more.

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EMA publishes Document on the Validation of analytical Methods

Is it possible to use the results of collaborative trials for analytical methods to prove the laboratory- and product-specific validation of a method? From the perspective of this EMA reflection paper the concrete specifications are missing. These will be developed in the future. Find out more in this news.

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IMPs: How do GDP Guidelines apply?

Is distribution of Investigational Medicinal Products covered by the new Guidelines on Good Distribution Practice (GDP)? What needs to be considered can be found here.

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European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D

The publication of the final ICH Q3D guideline, which has been announced for September of this year, will lead to extensive revisions to chapters and monographs in the European Pharmacopoeia. Find out in what steps the Pharmacopoeia Commission will proceed.

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Water Systems in FDA Warning Letters

Among the FDA Warning Letters of the past two years there are every now and then letters citing deficiencies in water systems. On the bottom line the reason for objections is always the same. Read more.

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Final ICH M7 Guideline on Genotoxic Impurities published

One and a half years after the release of the draft the finalized M7 Guideline for the assessment and control of genotoxic impurities in pharmaceutical products was issued. Read more about this.

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Every fifth FDA Warning Letter includes deficiencies regarding Equipment

In 19 of the total of 92 warning letters of the last two years, shortcomings regarding equipment are part of the complaints. The most commonly cited issues are maintenance (including calibration), cleaning and the qualification of equipment. Read more.

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Italian API Manufacturer Receives FDA Warning Letter for Data Integrity Issues

On July 7th the US FDA issued a Warning Letter to Trifarma S.p.A. for violating Good Manufacturing Standards at their facility in Rozzano, Italy. The company produces APIs and had been inspected early this year. Read more about this Warning Letter here

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ICH gets new Members and informs about the ICH Q3D Implementation

The International Conference on Harmonisation (ICH) is the most significant organisation for the harmonisation of requirements with regard to the authorisation and the manufacture of medicinal products. Read more about the current decisions of the ICH Steering Committees.

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Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters

An analysis of warning letters issued in the past fiscal year essentially shows the same pattern of frequently cited GMP violations. It also shows a noticeable increase in the GMP deficiencies relating to the qualification of suppliers and their certificates of analysis. Find out more.

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How can a CEP for a starting material be used in a CEP application for an API?

A CEP for a starting material offers several advantages, because it can be used for applying for an API CEP, which reduces the effort in the application process. However, this is linked to various conditions, which are described in a new document of the EDQM. Read more about this.

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When can a CEP be withdrawn?

In which cases does the EDQM temporary suspend an existing CEP or definitively withdraw it? When can an ongoing CEP application procedure be closed? You can find answers to those questions in a new document of the EDQM. Read more here.

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Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity

The applicant for an ANDA in the USA has to submit data of several stability tests. The FDA guidance on this topic coming into force last year left open some issues, however, that now are clarified with a questions and answers document published lately. Read more.

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New GMP Non-Compliance Reports in EMA Database

There are some new entries about GMP and GDP non-compliances in EudraGMDP, the European Inspection Database. Please read this news to find out more about the GMP and GDP Non-Compliance Reports.

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Austrian QP Association (aqpa) publishes Comments on the Annex 15 Draft

The publication of the revised draft of the EU GMP Guide's Annex 15 is the opportunity for the EMA to get comments on it. The opportunity has been used by the Austrian QP Associaton (aqpa). Read more about the comments.

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FDA Guidance for Industry: Electronic Source Data in Clinical Investigations

The FDA published its new Guidance for Industry (GfI) - "Electronic Source Data in Clinical Investigations" in September 2013. The Guidance defines the expectations of the FDA concerning electronic source data generated in the context of clinical trials.  Find out more about this Guidance.

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