Clinical Trials if there is no Brexit Deal

To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.


Non-Compliance at Chinese Heparin Manufacturer

A Non-Compliance Report due to several GMP violations has been issued to a Chinese heparin manufacturer after an inspection conducted by the Italian Health Authority. This report is now available on the EMA website for Non-Compliance Reports.


Swissmedic Document on the Role of the RP in Contract Manufacturing

The Swiss authority Swissmedic has published a new auxiliary document for the so-called "RP Declaration".


New WHO Guideline on Testing of Counterfeit Medicines

The World Health Organization (WHO) has published a new guideline describing the procedure for testing supposedly counterfeit or suspect medicines.


New ISO Standard for Tamper-Evident Packaging

The International Organization for Standardization has published the new ISO standard "Packaging - Tamper verification features for medicinal product packaging".


News from the ICH on Continuous Manufacturing

In June 2018 already, the International Council for Harmonisation (ICH) announced the coming issuance of a new ICH Guideline on continuous manufacturing. Now, the ICH has released further news about the planned content of the new guideline ICH Q13.


Cleaning Validation of Medical Devices: What should it look like? An ASTM Guide provides Answers

There are regulations for cleaning validation in the pharmaceutical sector and in the manufacture of active ingredients. But what about the cleaning validation of medical devices?


Things to Consider for Medical Device Manufacturers when Relocating

In December 2018, the FDA  published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?


Foreign FDA Inspections of Medical Device Manufacturers increase by 243% over the last 10 Years

In its "Medical Device Enforcement and Quality Report", the FDA has published current data on its monitoring activities with regard to medical device manufacturers. Find out what's new.


Hard Brexit: MHRA proposes necessary Arrangements

To face the possibility of a Hard Brexit, the British MHRA has issued an updated guidance proposing some necessary arrangements.


Cleaning Validation: What can a Quality Risk Management Approach Look Like?

With the implementation of the ICH Q9 document, risk management has become mandatory in virtually all GMP areas. This also applies to cleaning validation. But what can such a quality risk management approach look like for cleaning validation? The American Society of Testing and Material (ASTM) has recently issued a guideline on a Science-Based and Risk-Based Cleaning Processes Development and Validation. What does the Guide suggest?


Will EMA Plans change the Landscape of GMP?

EMA has published a strategic reflection paper "EMA Regulatory Science to 2025". As a consequence, the regulatory landscape, including GMP requirements and standards, needs to be adapted.


Process Validation: The Impact of Equipment Change

In a previous News you could already read about the cleaning issues at a US-American pharmaceutical company. Now, the Warning Letter issued provides much more information - also with regard to process validation.


New VDI Guidelines for Clean Room Technology

The Association of German Engineers (VDI ="Verein Deutscher Ingenieure") has recently released two new draft guidelines from the area of clean room technology: one regarding central air handling systems, and the other one regarding air filter systems.


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