GMP News 2017

And the EMA goes to ... Amsterdam

When Britain leaves the EU, the European Medicines Agency (EMA) will have to move as well. The final decision where to was made by drawing the name of the new EMA location out of a hat. How could that happen?

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USA: Track & Trace Realisation Postponed by a Year

In June, the FDA reported that the enforcement of requirements for the safety of supply chains will be postponed by a year. The new date is now November 27, 2018. Find out more about the change of the date in the FD&C Act.

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Data Integrity - Implementation status

Data Integrity deviations are still in the focus of regulators. Nevertheless you will find only general requirements regarding Data Integrity in the GMP Guidelines. More detailed guidelines on Data Integrity are on the way but mostly available as drafts. Get an overview on the current situation and the first implementation steps of Data Integrity activities. 

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GVP Update 2017

There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more about the revisions of several GVP Modules and the published draft of Product- or Population-Specific Considerations IV: Paediatric population.

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EudraVigilance: EMA's new Signal Management Guide

In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry.

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FDA's new Guidances on the Approval of Generic Drugs

The FDA has recently published various guidelines on application procedures for generics. Read here, which special requirements have to be met for the authorisation application of generics for the US market.

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Will FDA now stop conducting GMP inspections?

The European Medicines Agency (EMA) has updated its Q&A section on the Mutual Recognition Agreement. These questions mainly refer to the start of the operating phase of the MRA on 1 November 2017.

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Insufficient Media Fills in FDA Warning Letter

Insufficiently planned and performed media fills were at the centre of an FDA Warning Letter. Read more about the criticised deficiencies from a Warning Letter to the Korean manufacturer Firson Co., Ltd.

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Revision of the USP chapter on Raman

Raman is a technique often used for incoming API and excipients inspection besides IR and NIR. New suggestions for updating the chapter were published in the USP's Pharmacopeial Forum. Find more information on USP chapter <858> Raman Spectroscopy.

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The ICH E11 Addendum on clinical investigation in children now enters into implementation

The ICH E11 Addendum reached Step 4 of the ICH Process and now enters into the implementation period. Read more about ICH E11 Clinical Investigation of Medicinal Products in the Pediatric Population.

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EMA publishes Concept Paper on Guidance Development on non-clinical Evaluation of Radiopharmaceuticals

The European Medicines Agency (EMA) evaluated an additional use for guidance relating to non-clinical evaluation of radiopharmaceuticals and published a new concept paper on the development of such a guidance.

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Positive Balance for Implementation of the Falsified Medicines Directive

The soon-to-be required safety features for the realisation of the Falsified Medicines Directive must be implemented by February 09, 2019. The German initiative securPharm strikes a positive mid-term balance. Read more on the securPharm press release.

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MRA: FDA now recognizes EU Inspectorates in 8 of 28 countries

Since 1 November, the MRA has been in the operational phase. The FDA now recognizes EU inspectorates in 8 of 28 countries - the majority of countries is not yet recognized.

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Data Integrity from an Inspector's Point of View

Even though the integrity of data has always been one of the basic principles of GMP, the topic has come more and more into the focus in inspections of the last 3-4 years. Read more about an inspector's viewpoint on data integrity.

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Violation of GDP Guidelines and Counterfeiting of Medicines - a Current Case Demonstrates the Dangers

The trade press has extensively covered the counterfeit of Harvoni, a pharmaceutical produced by Gilead. The background circumstances as well as the consequences to be drawn from this incident are of interest here. Read more about the counterfeit case and the GDP consequences.

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European GDP Association nominates two new Advisory Board Members

The European GDP Association has been growing steadily since its foundation as Good Distribution Practice Interest Group in 2013. Now it represents close to 1.900 professionals from all over the world. Recently the Association announced that two new members joined the Advisory Board.

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FDA criticises Process Validation Deficiencies

In a recent warning letter issued to "Wuxi Medical Instrument Factory", the FDA criticised deficiencies concerning process validation, amongst other things.

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FDA Form 483 due to Particle Findings in a Product

The company Celltrion in South Korea received a so-called Form 483 report as a result of an inspection of the facility in May and June 2017. Amongst other things, it criticised particle findings in released products, insufficient environmental monitoring and deficiencies in aseptic activities. Read more about the deficiencies found during the inspection.

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FDA Finalises Guidance on Emerging Technology Applications

The "Emerging Technology Applications for Pharmaceutical Innovation and Modernization" Guidance was already published as a draft in December 2015. Now the final Guidance is available.

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EU Inspection Complaints due to inadequate Handling of OOS Results

The recall of already released batches, the withdrawal of the currently valid GMP certificate and the import ban for Europe are amongst the most notable consequences of an EU GMP inspection in India. The main focus was on faulty OOS management. Read this news for more information about the "Statement of Non-Compliance with GMP" for Dr. Reddy's Laboratories Ltd.

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Harmonisation of the pharmacopoeial Texts for use in the ICH Regions on Micro Enumeration finalized

Reaching step 5 of the harmonisation process, the European Medicines Agency (EMA) adopted the ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration.

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Specified Microorganisms - Harmonisation of the pharmacopoeial Chapters completed

The International Council for Harmonistion (ICH) finalized their recommendation relating to the use of the pharmacopoeial texts on tests for specified microorganisms.

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EDQM publishes Press Release on microbiological Control Symposium

Two weeks after their microbiology symposium in Strasbourg, the European Directory for the Quality of Medicines and HealthCare (EDQM) summarized the event in their press release entitled "Microbiological control symposium: consensus on readiness of new methods emerges".

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Rationale to the revision of USP Chapter <381> Elastomeric Closures for Injections

The USP has recently undertaken an in-depth review of chapter <381> which has resulted in significant revisions especially to the heavy metals and functionality tests. In a stimuli article the USP now provides the rationale for the proposed changes to USP general chapter Elastomeric Closures for Injections <381>.

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Important Questions and Answers concerning the Audit Trail Review - Part 2

The webinar "Audit Trail Review" took place in February 2017 - with the goal to address the main elements of data integrity and audit trail reviews. During this webinar more than 50 questions were asked. As time did not allow to answer all of them, the webinar's speaker, Dr Wolfgang Schumacher, provided comprehensive answers later. Find out what questions regarding Audit Trail Review were asked and how they were answered.

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