The MRA between Japan and EU will be extended

The Mutual Recognition Agreement on GMP products (MRA) between the EU and Japan will soon be amended to include APIs, biologics, and vaccines.


Heparin in the FDA's Focus once more: Warning Letter for Chinese Contract Lab

Despite many regulatory initiatives resulting from the heparin scandal, inspections still discover companies linked to contaminated heparin. Read more about the GMP violations concerning the analysis of heparin and the handling of raw data in a Chinese contract laboratory.


EMA's updated Implementation Plan for the Introduction of Safety Features

The soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use. Read more about the EMA's implementation plan for safety features.


FDA Warning Letter for inadequate Batch Record Review

The US Food and Drug Administration (FDA recently posted a Warning Letter for a Chinese API manufacturer criticising the quality unit for not exercising its responsibility adequately.


What is GMP compliant Equipment Design?

It's a frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP compliant equipment design.


How to use Freezers and Refrigerators

In a recent post MHRA describes some of the main issues with freezers used by pharmaceutical wholesalers.


GDP: Questions & Answers about the Scope of the EU-GDP Guidelines

Do the EU-GDP Guidelines apply for Veterinary products and IMPs? These questions are answered in a new set of Q&As of the European GDP Association.


Comprehensive Overview on WHO Storage and Transportation Guidelines

The European GDP Association has now put together WHO's GDP documents to provide a better overview and easier access.


Glass Particles due to Delamination

The formation or flakes of glass particles on the inside of glass containers is referred to as delamination. These glass fragments, created by the interaction of the solution with the container walls, can pose a risk, especially when it comes to parenterals.


WHO's Position on the Import Alert for a Chinese API Manufacturer's Products

When an inspection unearths severe GMP violations, the FDA sometimes issues a ban on imports for the concerned products of a company. Read here what conflicts can arise when such an import alert concerns APIs of a Chinese manufacturer which were classified as prequalified in an inspection by the WHO beforehand.


EU Clinical Trial Regulation will come into application during 2019 instead of October 2018

The European Medicines Agency (EMA) recently posted on its website that the new EU Clinical Trial Regulation will come into application during 2019 instead of in October 2018, as previously announced. Read more about the new time schedule for application of  the Clinical Trial Regulation EU No. 536/2014.


New USP Chapter <1062> Tablet Compression Characterization

A new USP general Chapter that describes the basic principles and practices used in the characterization of tablet compression has been approved and published. Read more about the new USP chapter <1062> Tablet Compression Characterization.


Being inspected by ANVISA? Or COFEPRIS?

Quite a few supervising authorities in the health care sector come for GMP inspections also to foreign countries. Here you can read what the Brazilian ANVISA and the Mexican COFEPRIS will expect.


How often do HEPA Filters have to be changed?

In the pharmaceutical industry, HEPA filters are used as terminal filters for the processing or filtration of air in production spaces. They are mandatory in sterile production, although they are somtimes also used in the manufacture of solid or semisolid dosage forms. Amongst the HEPA or high-efficiency particulate filters are Filter Classes H13 to H14 (DIN 1822), the latter with a retention rate of 99.995%. But how often do HEPA filters need to be changed?


FDA Draft Q&A on Electronic Records and Signatures in Clinical Trials

FDA recently published a draft document on the use of electronic records and signatures in clinical trials. Read more about FDA´s draft document Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.


Visual Inspection Board finishes work on Container-/Closure-Integrity Document

Members of the ECA Visual Inspection Board have finished their work on a position paper regarding Container-/Closure-Integrity testing. The new document is now available in the download section of the ECA Visual Inspection website.


Elemental Impurities - Binding Risk Assessment for Authorised Medicinal Products

EMA's document on the implementation of ICH Q3D for already marketed products contains essential recommendations for marketing authorisation holders. Learn why risk assessments with regard to elemental impurities for existing marketed products are so important and how to decide about the necessity of a variation procedure.


Swissmedic specifies Requirements for RPs

The current edition of the Swissmedic Journal 05/2017 and the Technical Interpretation I-SMI.TI.17 specify the requirements with regard to the independence and the obligation of presence of the Swiss QP.


Maintenance Cycles of pharmaceutical Water Systems

To maintain the qualified state of a pharmaceutical water system, a reliable maintenance plan is necessary. This is an official requirement, though it does also make sense from an operational viewpoint. Maintenance intervals based on the criticality of individual components are usually defined during qualification. But what is the rule here?


Burkholderia cepacia - FDA Advice on Contamination Risk

Recent recalls determined FDA advice to drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products.


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