GMP News

FDA Warning Letter for Canadian Drugmaker - HPLC and Data Integrity in the Focus

The U.S. Food and Drug Administration (FDA) has recently published a Warning Letter to a Canadian over-the-counter (OTC) drug producer. During an inspection, the FDA found significant violations of current good manufacturing practice (CGMP), including data integrity issues related to HPLC analysis.

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Publication of the WHO Document on Limits in Cleaning Validation

The issue of (cross-) contamination and, in this context, cleaning validation have played an important role in the GMP environment for decades. For some years now, health-based exposure limits have been added as a possible alternative. In a draft guideline, the WHO has addressed this topic.

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Pharmaceutical Associations underline Importance of MRA with UK

Several European pharmaceutical associations are calling on the EU to give priority to access to medicines in the ongoing Brexit negotiations. Specifically, they are calling for an MRA.

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CEPs: What Applicants and Authorisation Holders should know!

Due to the corona pandemic, many processes and regulations are currently in change - information regarding the current procedures for applying for CEPs is listed on the EDQM website.

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CMDh: Update of the Q&A List Variations

The Q&A document on variations entitled "Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008" of the CMDh and CMDv was updated again in May 2020.

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23rd APIC/CEFIC Global GMP & Regulatory API Conference 2020 - Regulatory Affairs part

Recommended Event

Amsterdam, Netherlands

29/30 October 2020

23rd APIC/CEFIC Global GMP & Regulatory API Conference 2020 - Regulatory Affairs part

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