GMP NEWS 2014

FDA issues Guidance for a clear Identification of pharmaceutical Companies

In November the US FDA has issued a Guidance for a clear identification of pharmaceutical companies. The authority now definitely prefers the DUNS system. Get more information.

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Frequent GMP Question: How many Signatures are required for Validation Protocols/ Reports?

As part of the validation and qualification activities for the production of medicinal products, the following question often arises: how many signatures have to be put under the respective protocols and reports? Which part do the Heads of Production and QA play for the signatures? Read more about the answers provided by the EU GMP Guide.

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ICH Working Group Elaborates Training Materials on ICH Q3D

In two recently published documents, the ICH has informed about the establishment of an "Implementation Working Group" for ICH Q3D "Elemental Impurities" and the elaboration of training materials on the requirements of this guideline. Read more here.

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Best Practice Paper on Visual Inspection now available for download

After the transition of the ECA Visual Inspection group from a working to an interest group, it is now possible to join the group for free. Group members have access to the full site content including the download of the best practice paper on visual inspection. Read more.

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Corrigendum of the EU Counterfeit Directive

In the Official Journal of the European Union from 9 August 2014, two corrigenda to the counterfeit directive have been published with regard to the prevention of the entry into the legal supply chain of falsified medicinal products. Please read more details here in this News.

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Delegated Regulation on GMP for APIs published in the Official Journal of the EU

The bindingness of the GMP principles for APIs has been set in a EU-wide applicable regulation - in a so-called "Delegated Act". Read more here.

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Warning Letter: Deficiencies in Visual Inspection

In October 2014, the US FDA issued a Warning Letter to the company Hikma Pharmaceuticals justified by deficiencies in the visual inspection of vials. Read more here.

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Shared and Dedicated Facilities: EMA publishes final Guideline on Setting health based exposure limits (PDEs)

The EMA has now published the long awaited final version of the Guideline which sets the exposure limits of products manufactured in so-called shared facilities. Read more here.

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New USP Proposals on "Supply Chain Integrity"

In a publication in the Pharmacopeial Forum, the USP describes the future USP chapters planned for Good Distribution Practices (GDP). The new Chapter <1083.4> focuses on the supply chain integrity and security. More information can be found here in the News.

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New Q&A concerning Visual Inspection

The topic 100 percent visual control of parenterals constantly raises new questions, especially as concerns the use of automatic inspection machines or if statistical issues emerge concerning AQL inspections. To find some of these questions and answers by Dr. Tobias Posset (Head of Production Support at Roche Diagnostics) please read here.

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Managing CAPA and Investigation Processes still in the Focus of Inspectorates

Deviations and CAPA remain hot topics in inspections, as a new MHRA report shows. Read more.

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EMA Guideline on similar Biological Medicinal Products adopted

On 23 October, the CHMP adopted the revised Guideline on similar biological medicinal products. Get more details here.

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Import Restrictions for some Products from Japan

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human CMD(h) has revised a document defining restrictions for medicinal products from certain areas in Japan. Read more.

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New USP Requirements on Plastic Packaging Systems

The USP describes in an article of the Pharmacopeial Forum the future requirements for plastic packaging systems. Here, the importance is laid on the selection of suitable, safe plastic materials and the verification of potential interactions. More information can be found here in the News.

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Frequently asked Questions about Good Distribution Practice Implementation (EU)

The implementation of the new EU Good Distribution Practice Guideline is a challenging task for pharmaceutical companies, wholesalers, storage facilities and transportation companies. However, a very helpful document is available from the EU Commission which provides answers to a number of questions for GDP implementation. Read more about the Good Distribution Practice Q&As here.

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Ph.Eur Chapter 2.6.8. Pyrogens Revision open for Comments

In Pharmeuropa issue 26.4, the EDQM published the draft of the revision of chapter 2.6.8. Pyrogens. It is open for comments until 31. December 2014. Read more.

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Question and Answers to Endotoxin Masking and Low Endotoxin Recovery (LER)

Following ECA's webinar on Endotoxin Masking, the speaker summarized the questions related to masking and LER in a Q&A document. Read more here.

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EDQM revises 5.1.10. Guidelines for using the Test for Bacterial Endotoxins

Recently, the EDQM published the revision of 5.1.10. "Guidelines for Using the Test for Bacterial Endotoxins" and added alternative methods like recombinant factorC. More details can be found here.

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ECA and PQG publish next chapter of the interpretation of the EU GDP Guide

The ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG) have published an additional chapter of the interpretation of the EU Good Distribution Practice (GDP Guide). Click here to read more about the GDP interpretation

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New FDA Inspection Guidance gives the Agency more Power

Some companies delay or deny an inspection or even refuse the inspector to enter. A new FDA Guidance descibes what FDA can do when dealing with uncooperative companies. Read more.

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