GMP News - Inspections/Audits

17.04.24

Counter-Espionage Law: Do GMP inspectors no longer go to China?

As we reported at the end of last year, China has revised its counter-espionage law. Now there are fears that this will also affect GMP inspections and audits, as the German Handelsblatt writes.

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17.04.24

FDA sends Warning Letter to Canadian OTC Manufacturer

A manufacturer of over-the-counter (OTC) drug products based in Canada received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

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10.04.24

APIC: Best Practices Guide for dealing with Suppliers

The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.

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10.04.24

FDA's current Thinking on KPIs and Quality Metrics

The FDA's current approach to monitoring pharmaceutical manufacturing emphasises the importance of quality metrics in ensuring product safety and efficacy. What is behind this?

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03.04.24

Warning Letter to Chinese OTC Manufacturer: Violations concerning Identity Testing, Stability Program and Quality Unit

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products. The violations were identified during the FDA's review of records submitted by the company in response to an official request.

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03.04.24

Inadequate Equipment and Facility Design

A sterile manufacturer in Jordan received a Warning Letter from the US FDA for inadequate equipment and facility design as well as other deficiencies.

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27.03.24

EU Non-Compliance Report issued after insufficient CAPA

A recent EU Statement of Non-Compliance with GMP contains significant observations and requires the inspected company to carry out a detailed analysis, particularly with regard to CAPA.

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27.03.24

Court Ruling: Suspended Sentence and Heavy Fine for Falsifying Stability Data

A court in the UK has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified stability data to the MHRA in order to obtain a Marketing Authorization for a product. This was preceded by years of investigation by the authority.

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19.03.24

FDA Warning Letter to Drug Manufacturing Facility in Thailand

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Thailand. The violations include failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to release and distribution.

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13.03.24

APIs in Brazil: how to register and obtain the GMP certificate

In February 2024, the ECA offered the Live Online Training "How to register APIs in Brazil - Focus on CADIFA and obtaining a Brazilian GMP certificate". During the Q&A sessions, many interesting questions were posed to the speakers' team. A list of useful abbreviations and definitions in regard on the Brazilian registration system are collected and provided in the following.

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06.03.24

Non-compliance Report (EudraGMDP): Cross-Contamination Risk at Indian pharmaceutical Company

A non-compliance report was issued by the inspecting Maltese authority following an inspection at an Indian pharmaceutical manufacturer. The inspection was the follow-up inspection to an inspection already carried out in 2022, which was intended to monitor the implementation of the measures. According to the authority, the remaining deficiencies and risks of cross-contamination were problematic.

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28.02.24

What is an FDA Post-Warning Letter Meeting?

When reading an FDA Warning Letter, you might have recognised that under GDUFA programme, the facility may be eligible for a so-called Post-Warning Letter Meeting. But what is this?

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28.02.24

Pest Control - Warning Letter to US Company

Even animals with legs can keep the regulatory authorities busy. In December, a US manufacturer received a Warning Letter, the first section of which deals with deficiencies in the area of pest control.

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28.02.24

FDA Warning Letter: Data Integrity issues while manufacturing APIs

In February 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Sichuan Deebio Pharmaceutical Co. Ltd." after having inspected its site in September 2023. According to the Warning Letter the firm has a lack of microbiology laboratory Data Integrity.

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21.02.24

Another FDA Warning Letter for Chinese Company based on Review of Records

The U.S. Food and Drug Administration (FDA) has issued another Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals, based on a review of records.

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