News

The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available on the Internet. Since a few years now, major violations of GMP have been published in a European inspection database. The British Regulatory Authority (MHRA) does this in a much more detailed way. Read the following examples published by the MHRA on the topic area validation/qualification from 2015.

A News from March 2014 reported about EMA's revised process validation guideline entitled "Guideline on process validation for finished products - information and data to be provided in regulatory submissions". Now, the EMA has surprinsingly published a new revision of its Process Validation Guideline.

A news in June 2014 already reported about the APIC "Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Now, a revision has brought the APIC guidance in line with EMA's guideline on "Shared Facilities".

At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016. Please find here an analysis of this draft.