GMP News - Inspections/Audits

31.03.21

MHRA starts combined Distant / On-Site Inspections

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is launching a sensible and likely workable approach to resuming domestic inspections - a combination of distant and on-site inspections.

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17.03.21

EU accepts MHRA inspections

The EMA has updated its Q&A document on the implementation of the Protocol on Ireland and Northern Ireland and clarified the recognition of inspections.

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17.03.21

FDA stops another Delivery of Hand Sanitizer at the US Border

The U.S. Food and Drug Administration (FDA) has once again stopped a delivery of hand sanitizers with too low alcohol content. The Mexican manufacturer received a Warning Letter.

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03.03.21

APIC: Annual Update of the ICH Q7 "How to do" Document

Version 14 of the "How to do" Document - Interpretation of the ICH Q7 Guide and "Review form" for APIs, which has been available since the beginning of the year, mainly includes additions and updates in the chapters 11, 15 and 16. The How to do document is intended to facilitate the implementation of the ICH Q7 Guide and lists recommendations on how to interpret it.

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03.03.21

FDA criticises Supplier Qualification in Warning Letter

Although the FDA currently conducts virtually no inspections, Warning Letters continue to be issued; in January, for example, to a pharmaceutical manufacturer in Florida.

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24.02.21

Inspection of biotechnological Manufacturers - PIC/S AiM Updated

In January, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a revised version of its Aide Memoire "Inspections of Biotechnology Manufacturers".

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24.02.21

FDA stops Hand Sanitizers with too low Alcohol Content at the US Border

The U.S. Food and Drug Administration (FDA) pays close attention to what is inside hand sanitizer products imported into the United States. Recently, a product labeled as containing 75% ethanol, but in fact contained only 58%, was detained and refused admission at the border. As a consequence, the Chinese manufacturer received a Warning Letter.

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17.02.21

GAO criticizes FDA's current Inspections Approach

In a report published end of January, the U.S. Government Accountability Office (GAO) asks the US Food and Drug Administration (FDA) to review its inspections approach during the pandemic.

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17.02.21

FDA Applications during Covid-19: better Communication planned

With an updated Guidance document, the US Food and Drug Administration (FDA) plans to improve communication with industry.

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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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