GMP News - Inspections/Audits

26.01.22

FDA: Delays in Resumption of Inspections

The FDA announced that the agency is adjusting its planned inspection activities to the spread of the Omicron variant and has therefore temporarily postponed certain inspection activities.

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26.01.22

Inadequate OOS Investigations lead to FDA Warning Letter

Recently the U.S. Food and Drug Administration (FDA) issued a warning letter due to inadequate investigations into out-of-specification (OOS) test results.

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18.01.22

The GDP Non-Compliance Reports of 2021 - An Overview

Wholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority. If the outcome of an inspection is that the wholesale Distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP. For your information please see the comprehensive overview of the GDP non-compliance reports entered in 2021 and the respective reasons for issuing them.

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05.01.22

Q&As: China GMP and Registration of APIs

In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers' team.

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21.12.21

Revised IPEC GDP Audit Guide for Pharmaceutical Excipients Available to the General Public

In September 2021, the International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021). After the guide was initially only accessible exclusively to IPEC members for three months, the document was now made available to the general public.

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21.12.21

GDP Non-Compliance Report for German Wholesale Distributor: No GDP Conform Quality System and No Suitable and Adequate Premises

The competent authority of Germany (Bezirksregierung Köln) has entered a new GPD Non-Compliance Report dated 03 December 2021 into the EudraGMDP database. Due to the seriousness of the violations, the Wholesale Distributor Authorisation was revoked.

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15.12.21

Remote Inspections: Reflections on the global Transformation of international Inspections

The ICMRA has published a report on remote inspections with valuable advice for the pharmaceutical industry, also for its own preparation and implementation.

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08.12.21

Q&As from the EMA Webinar for Industry on Integration of EudraGMDP and OMS

At the beginning of October, we reported on important changes for entries in the EudraGMDP Database. To inform about the new developments, the EMA had organized a webinar for industry on the integration of EudraGMDP and OMS. The EMA has now published a 13-page Q&A document with 87 questions raised during that webinar.

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01.12.21

TGA: On-going use of Remote Inspections

As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.

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24.11.21

New FDA Commissioner - Online FDA Symposium available free of Charge

With Dr Robert Califf, President Biden has now nominated an expert in clinical trials who has previously served as an FDA Commissioner.

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17.11.21

In 2021 again Numerous FDA 483s due to Deficiencies in the Stability Program

Only recently, we reported that in fiscal years 2019 and 2020, deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms. The FDA has now published the data for the fiscal year 2021. About a fifth of the 483s revolve around the issue of stability.

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10.11.21

Fire in Production! What are appropriate CAPAs?

An interesting case of two fires occurred at an API manufacturer in the USA. This is described in a Warning Letter from the FDA that was recently published.

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03.11.21

EU: Important Document for Inspections revised

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.

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03.11.21

Contract Manufacturing as a Topic in a new Warning Letter

Supplier qualification, contracts and quality oversight are also important to the FDA. This is reflected in a recent Warning Letter from the authority.

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27.10.21

GMP Inspections: Do you know IRIS?

In the course of an expansion, the IRIS platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.

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