GMP News - Inspections/Audits

02.08.23

MRA between Switzerland and the USA now effective

The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of GMP for medicinal products has entered into force. It applies to both human and veterinary medicinal products.

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26.07.23

FDA criticised over inadequate GMP Inspections in India and China

Republican Congress members are worried that the US is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA regulations and express this in a letter to the FDA Commissioner.

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26.07.23

FDA Warning Letter: Using non-validated and not appropriate Test Methods from an Internet Search is not a good Idea

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. The company in question manufactures over-the-counter (OTC) topical drug products, e.g. antibacterial hand soaps and hand sanitizers. The list of GMP violations is quite extensive and concerns, among others, QU oversight, handling of out-of-specification (OOS) results, identity testing, and laboratory controls in general.

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26.07.23

New in the ECA Members Area: "QA Responsibilities" in the Mirror of Warning Letters

The FDA's Warning Letters contain detailed descriptions of GMP deficiencies and thus provide a useful perspective in the context of preparing for an FDA inspection. In the members' area of the ECA Academy website, topic-focused descriptions of these GMP deficiencies are available, e.g. a compilation on GMP violations in the area of quality assurance.

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25.07.23

CEP 2.0: Insights into Inspection Reports

As part of the implementation of the new "CEP 2.0", the EDQM has now published on its website a list of authorities and organizations that have insight into inspection and assessment reports.

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18.07.23

Turkish Authority publishes new Guideline on GDP Inspections

The Turkish Medicines and Medical Devices Agency (TITCK) has published a new revision of its guidelines related to inspections regarding the storage and distribution of medicinal products for human use.

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11.07.23

FDA now also assesses Countries and Regions as a Risk Factor

The FDA has updated one of its internal manuals to add a risk factor for facilities in countries where there has been an increase in violations. This is nothing more than a risk factor for a region or an entire country.

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05.07.23

Packaging of Solid Dosage Forms: Warning Letter in the USA

Due to numerous GMP deficiencies, a US company in the field of solid dosage form packaging received a Warning Letter from the FDA. The inspection had already taken place in November 2022. Since the FDA found the company's response to the Form 483 as insufficient, the Warning Letter now followed.

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14.06.23

Appearance as a Release Test? This is not the Way to get through an Inspection

The FDA has issued a Warning Letter to a manufacturer in the USA who has not adequately tested its drug products. And the manufacturer relied on others for supplier qualification.

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14.06.23

Inadequate Cleaning of Product-Contact Surfaces

In a Warning Letter, the FDA describes the inadequate cleaning of product-contact surfaces and the associated risk of cross-contamination at an Egyptian pharmaceutical manufacturer.

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07.06.23

MRA: EU-US Agreement to recognise GMP Inspections for Veterinary Medicines

The Mutual Recognition Agreement (MRA) between the EU and the US will be extended to veterinary medicines. This was announced by the EU Commission in a press release.

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31.05.23

FDA Form 483 due to Insufficient Investigations after OOS and OOT Results

The U.S. Food and Drug Administration (FDA) has published a Form 483. During an inspection at an Indian drug manufacturing side, several CGMP violations were documented. These concerns, among others, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, where results were invalidated by retesting the batches without a scientifically justified root cause.

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31.05.23

Registration of APIs in Brazil - Q&As

In March 2023, the ECA offered the Live Online Training "How to register APIs in Brazil". With regard to Brazil's Registration procedures for APIs, a set of the most important questions raised during the training and the respective answers provided by the speakers Ms Marieke van Dalen, Global Regulatory Specialist, Aspen, The Netherlands, and Ms Susan Swiggers, Customer & Regulatory Support Officer, Aspen, The Netherlands, are listed in the following.

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31.05.23

What does the FDA actually mean by CGMP?

Good Manufacturing Practice is referred to as GMP in the EU, in almost all PIC/S countries and at WHO. The FDA, however, refers to it as CGMP. But what exactly is behind it? The FDA has published a paper on this.

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17.05.23

Dead Leg in Pharmaceutical Water System leads to Warning Letter

Due to deficiencies found in an FDA inspection, a US pharmaceutical manufacturer has now received a Warning Letter. Among other things, a dead leg in the pharmaceutical water system is listed as a deficiency.

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