GMP News

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.


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