New FDA Guidance for shared Manufacturing of Biologics

Due to the more and more complex manufacturing of biologics there is an increased need for flexible manufacturing agreements between different companies for sharing or contracting development and manufacturing of biologics to optimise costs and risk. For that reason the FDA recently issued a new guidance. Read more here.


Guidelines concerning Paediatric Clinical Trials and EudraCT published

Eudralex Volume 10 has been amended with guidelines concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT), and on EudraCT information to be made public. Read more.


EMEA Publishes New Version of the Reflection Paper on QP Discretion

The EMEA published a revised version of the "Reflection Paper on a proposed solution for dealing with minor deviations from the detail described in the Marketing Authorisation". Read more about the changes here.


API Focused MHRA Inspections at Dosage Form Manufacturers

In the recently issued document entiteled “API focused MHRA Inspections at dosage form manufacturers" the UK authority emphasised final dosage form manufacturers' responsibility relative to the GMP compliant API manufacture. Find out more.


Medical Devices Warning Letters Report 2008 - CAPA 1st

The Medical Devices Warning Letters Report for 2008 shows that CAPA deficiencies are in the lead again. To find out more details about the top 5 "hit list" please read here.


FDA Globalization Act: Far-reaching Consequences for the Pharmaceutical Industry

The US Congress has introduced the so-called Food and Drug Globalization Act of 2009 to the US House of Representatives. This act contains points concerning the FDA's future orientation, some of which will have significant impact on the pharmaceutical industry. See some examples.


Warning Letters Report 2008 - Frequent Deficiencies in Deviation Reviews

In the past fiscal year (October 2007 through September 2008) the FDA issued severly more warning letters due to GMP deficiencies than in the previous year. To find out more, please see the systematic analysis of the authority's warning letters.


Compliance Problems through Acetonitrile Shortage?

Acetonitril shortage is a key issue in analytical laboratories at the moment. It will be addressed at ECA's Education Course "Maximising HPLC Productivity". Read more here. 


Monoclonal Antibodies - Comments received on the Guidelines

The European Medicines Agency (EMEA) published an overview of comments it received on the Guideline "Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products". Please read here.


Annex 8 of ICHQ4B in Step3

In the context of the ICH activities, the ICH Topic Q4B Annex 8, Sterility Test, General Chapter in Step 3 has now been published as well. It shows the results of the ICH Q4B Expert Working Group on the chapters Ph.Eur. 2.6.1. Sterility, JP 4.06 Sterility Test, and USP <71> Sterility Tests. Get more information here.


Dissolution Test - New ICH-/EMEA-Document

For several years now, the Pharmacopoeial Discussion Group and the ICH Q4B Working Group have been dealing with the harmonisation of the requirements laid down in the pharmacopoeias. In the meantime a number of ICH Topic Q4B Annexes have in fact been published. Read on here.


WHO Guide regarding GMP-Training Requirements

The WHO offers a guide to good manufacturing practice regarding training requirements. It is a very helpful document because there are a lot of practical examples available in the document (e.g. training SOPs, feedback questionnaires). Get more details here.


Acceptance of Third-Party Audits - Will There Be an Accreditation?

With regard to third party GMP audits, discussions frequently revolve around their acceptance. But actually the EMEA already defined in a Q&A document in 2006 that the drug manufacturer's QP has to select and authorise the third party. Get more information here.


List of new, withdrawn and revised FDA guidances published

The FDA has published its yearly list of new, withdrawn and revised CDER guidances. Read more.


Pediatric Drug Development: FDA Requirements

Under the Pediatric Drug Development Website, FDA's CDER has summarised all important links to applicable Regulations, Guidances and other important information. Read more.


New FDA Guidelines for an Increased Safety of Medicinal Products and Foodstuffs

Only five weeks after the publication of the European Commission's strategy for increasing the safety of medicinal products in the EU, on 15 January 2009 the FDA also released a package of three new guidelines for commenting. Read more.


FDA Starts Secure Supply Chain Pilot Programme

The FDA starts a pilot programme to improve the safety of imported medicinal products and active pharmaceutical ingredients, which is called Secure Supply Chain Pilot Programme. Read more.


Track and Trace - New EU Requirements on the Packaging of Medicinal Products

In December we reported about the European Commission's package of measures intended to ensure the supply of safe, innovative and accessible medicines to European citizens. To get more information on the legislative proposals meant to stem the increasing number of counterfeit medicines, please read here.


The New APIC Quick Guide for Procuring GMP-Compliant APIs

The new "APIC Quick Guide for API Sourcing" includes suggestions on how suppliers of active ingredients and starting materials can be evaluated. However, it is also directed at the API manufactures themselves and gives them recommendations for confidence-building measures towards their customers among the pharmaceutical companies. Get the details here.


Which Changes Have to Be Made to the Validation Strategy Due to the New FDA Process Validation Guide?

After the publication of the new FDA Process Validation Guidance, the companies will have to change their validation approaches. The classic 3 validation batches are no longer enough. With the help of a survey we intend to find out which conclusions the companies will draw. Furthermore, the results will be sent to the FDA within the framework of the commenting period. Find more here.


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