GMP News - Inspections/Audits

10.02.21

Insufficient Quality System leads to GDP Non-Compliance Report

Wholesalers must ensure that their Quality Management Systems (QMS) is aligned with the GDP requirements. Otherwise, this can lead to a GDP Non-Compliance Report, as a recent example entered into the EudraGMDP database by the Romanian authority shows.

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03.02.21

PMDA publishes Remote Inspection Guidance

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published an English version of a Procedure for Remote Inspections.

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27.01.21

Janet Woodcock new FDA Acting Commissioner

When the new US President Biden took office, the previous FDA Commissioner resigned from his position. Now, Dr Janet Woodcock was named Acting FDA Commissioner.

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20.01.21

Distant Assessment - an Option for the Future?

Due to the current pandemic and the associated restrictions, assessments are increasingly being performed remotely. Are these Distant Assessments also an option for the post-pandemic period?

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13.01.21

Brexit Agreement - what now?

Brexit: The agreement on the future relationship between the European Union and the United Kingdom is here. What are the consequences for medicinal products?

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05.01.21

FDA Warning Letter: No Adequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to a US over-the-counter (OTC) drug manufacturer due to significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

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16.12.20

Still no remote FDA Inspections: Criticism grows

Since the beginning of the pandemic and the associated travel restrictions, the FDA has been hesitant to decide whether to conduct distant assessments. Now, more and more criticism is spreading.

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16.12.20

Swissmedic clarifies Validity of GMP Certificates during the COVID-19 Pandemic

The Swiss Agency for Therapeutic Products Swissmedic has published a press release clarifying the validity of GMP certificates during the COVID-19 pandemic.

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09.12.20

EMA Distant Assessment Guidance

EMA has published a Guidance document, providing points for consideration relating to Distant Assessments.

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09.12.20

Warning Letter due to Inadequate Pressure Stage Concept and Particle Monitoring

Due to deficiencies in the ventilation system and particle monitoring in the sterile area, an Indian pharmaceutical manufacturer has recently received a Warning Letter from the U.S. FDA. In addition, the microbiology testing was also criticized.

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09.12.20

Blind Trust in Supplier Certificates and Inadequate Final Testing - An Analysis of FDA Warning Letter

A look at the warning letters to pharmaceutical companies of the last nine months of the current fiscal year (Oct. 2019 - June 2020) shows the most frequent GMP violations found by FDA inspectors. Read more about the Warning Letter Analysis in this article of the GMP Journal

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02.12.20

FDA Warning Letter for not Adequately Testing Components prior to Use in the Manufacture

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Mexican manufacturer. According to the FDA, the firm did not adequately validate the process and qualify the equipment used to manufacture the drug products. Furthermore, the company did not adequately test components prior to use in the manufacture of drug products destined for the US market.

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25.11.20

Covid-19: Swissmedic adapts Inspections

Swissmedic inspections may be carried either out on-site, (partly) by means of remote assessments or at a later point in time.

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18.11.20

Updated version of APIC's "How to do"- Document on GMPs for APIs

The updated version of the paperback "ICH Q7 Side-by-Side Comparison", which lists and compares the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" with the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" on GMPs for APIs, is now available.

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28.10.20

Warning Letter to Indian Manufacturer: Dead Legs and Missing Validation

Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.

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