GMP NEWS 2013

Recombinant and Human Plasma-derived Factor VIII Products

The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor VIII products. Find out more.

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Plasma-derived Medicinal Products

Providing guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products the "Guideline on plasma-derived medicinal products" became effective in 2012. Read on here.

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New EU Template for QP Declaration (IMPs)

The European Commission has published a draft template for the QP's declaration concerning GMP compliance of IMPs manufactured in non-EU countries. Read more.

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New Eudralex Vol.10 Guidance

The EU Commission has published a technical guidance providing a visual representation of the clinical trial results data that is required to be captured by EudraCT. Read more.

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EMA issues Concept Paper for Antimicrobial Resistance Risk Assessment Guideline

Antimicrobial resistance is an important issue for the marketing authorisation of veterinary medicinal products. On January, the European Medicines Agency published a concept paper for a guideline on antimicrobial resistance risk assessment. It is open for public consultation now. Find out more.

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Responses to the public Consultation on the Paediatric Regulation

The results of a public consultation on the experience acquired with the Paediatric Regulation have been published. Read more.

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New Guidance for Recall of IMPs

The European Commission has published the revised EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely and also details additional requirements for recalling IMPs. Read more.

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FDA publishes List of planned Guidances for Medical Devices

At the end of 2012 the Center for Devices and Radiological Health (CDRH) published a list with the Guidances planned for the fiscal year 2013 (1 October 2012 to 30 September 2013). Read more here.

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Regulatory Requirements concerning Quality Assurance of Medical Devices in Japan

Japan is an interesting market, also for medical devices. There exists a translation of the relevant Japanese regulation in the English language as concerns the regulatory requirements on the quality assurance of medical devices. The Japanese Ministry of Health, Labour and Welfare issued a Ministerial Ordinance under the number 136 in 2004 which also is available in English. Read more.

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China-Europe: Information on Standards and Market Requirements

The Europe-China Standards Information Platform provides bi-lingual information to Chinese and European businesses on everything from technical regulations to market access requirements. Read more.

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Guidelines for formalised Risk Assessment of pharmaceutical Excipients issued

Recently the EU Commission issued draft guidelines on the formalised risk assessment of pharmaceutical excipients. These drafts comprise definite specifications for determining the risk profile of the excipient and the manufacturer which the pharmaceutical manufacturer using these excipients has to apply. Read more.

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Laboratory Data Integrity in FDA Warning Letters 2012

Demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful inspection for any GMP regulated quality control laboratory. Please find in our News selected key citations regarding Laboratory Data Integrity in FDA Warning Letters from 2012.

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WHO GMP approaching EU-GMP

The current good manufacturing practices (GMP) for pharmaceutical products of the WHO are going to be updated. Read more.

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Up to $190.389 for FDA's New Inspections Fees

Many in the GMP environment haven't realised the consequences of the so-called Generic Drug User Fee Act (GDUFA) yet. The FDA has now published the exact fee rates for facility inspections. Read more here.

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Discussion of elemental Impurities in pharmaceutical Water

The question arose if pharmaceutical water need to comply to the requirements of USP <232> with regard to elemental impurities, especially if water is the main component of a medicinal product. These requirements are much more tighten than the traditional test on heavy metals (pb) which has been replaced by the conductivity measurement. Read more.

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Cross-contamination: Topic of the Revisions of Chapters 3 and 5 EU GMP Guideline

The revisions of the chapters 3 and 5 of the EU GMP Guideline published in January concern exclusively the topic cross-contamination and the measures aimed at minimising the risk of cross-contamination. Read more.

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PDA publishes Technical Report on Cleaning Validation

At random intervals the Parenteral Drug Association (PDA) publishes so-called "Technical Reports" (TR) concerning GMP topics. They are a potential source to get more information on the state of the art concerning the respective topic. The PDA published the Technical Report No 29 on "Points to Consider for Cleaning Validation" as early as 1998. This report has now been published again in an updated version. Read more.

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Outcome of the public Consultation on the Review of the Variations Guidelines

The European Commission has published a document summarising 40 contributions made by stakeholders. Read more.

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India Preparing for the Issuance of Written Confirmations

The Indian website "Drug Regulations" reported on 14 January about the first concrete steps regarding Written Confirmations taken by India. Read more here.

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New: ICH Q4B - Annex 13 on the Density of Powders

The procedures described in the pharmacopoeial texts for the determination of the density of powders now were judged to be equivalent in the three ICH regions Europe, USA and Japan and were published in the ICH Guideline Q4B Annex 13. You can obtain more information in this news. 

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