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.


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.


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.


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.


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.


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.


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>.


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.


Warning Letter due to Deficiencies in Filling System Design/Testing Particulate Matter

Due to deficiencies in the design of the filling system as well as the testing for particulate matter, the FDA has issued a warning letter to an Italian manufacturer of sterile products in Rome. Read more about the deficiencies resulting in a Warning Letter. 


Responses to public consultations on recommendations related to clinical trials

The feedback to the public consultations on recommendations related to clinical trials is now available online. Read more about the comments to the four draft guidelines issued in June 2016 regarding clinical trials.


New EU GMP Guideline for IMPs

The EU Commission published two new GMP documents in the Official Journal of the European Union. Learn more about the GMP Directive 2017/1572 for medicinal products for human use and the Delegated Regulation 2017/1569 on GMP for investigational medicinal products (IMPs) and requirements for inspections.


Similarity by Design: EMA Reflection Paper on statistical Methodology for comparative Assessment of QAs

The European Medicines Agency (EMA) recently released a draft Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.


"Analytical Procedure Lifecycle Management" Guidance for all participants of the APLM Conference

ECA's Analytical Quality Control Group (AQCG) is currently drafting a comprehensive new Guideline on 'Analytical Procedure Lifecyle Management' (APLM) to support the lifecycle approach for analytical procedures. Find out more about this new and important APLM Guidance document and the related APLM Conference.


FDA Draft Guidance on CMC Postapproval Manufacturing Changes for Specified Biological Products

In August, the FDA published a Draft Guidance for Industry on CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.


FDA publishes Biological Product and HCT/P Deviation Reports for Fiscal Year 2016

The US Food & Drug Administration (FDA) published a deviation report for Biological Products and HCT/P for Fiscal Year 2016, comparing the results with the two years before.


EDQM publishes Guidance for root-cause Analysis of non-satisfactory external Quality Assessment Results

The European Directory for the Quality of Medicines and Healthcare Products (EDQM) published a guidance document on the handling and root-cause analysis of Non-Conformity results in quality assessments. 


New Timeline Announced for the Implementation of the EU GCP Regulation

The European Medicines Agency, EMA, announced a new timeline in its press release dated 6 October 2017. According to this, the EU GCP Regulation will be applied mid-2019 at the earliest.


Inspections: Switzerland changes Conditions

The Federal Assembly has revised Art. 64a of the Therapeutic Products Act which regulates cross-border inspections. Read more about the changes in the Swiss Therapeutic Products Act.


Frequent GMP Violations in pharmaceutical Companies (1): Testing and Release for Distribution

More and more frequently, FDA inspectors find fundamental GMP deficits at facilities producing finished medicinal products. The following analysis of recent warning letters shows that the final testing of pharmaceutical products for compliance with the specifications can not always be taken for granted.


MHRA elaborates on new EU regulations for medical devices and IVDRs

Despite Brexit, the British "Medicines and Healthcare products Regulatory Agency" (MHRA) informs about new EU regulations for medical devices.


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