GMP News

FDA gets expanded Power to prevent Medical Device Supply Disruptions

Due to the Corona pandemic, there were supply shortages of medical device products in the USA. To get these shortages under control in the future, the FDA gets expanded power. What is planned?

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Final EMA Guideline: Quality Requirements for Combination Products

Following a draft version, the EMA has now published the final guideline, which describes what documentation is required on the subject of quality for combination products in order to gain and/or maintain a marketing authorization. The guideline consists of 22 pages with 10 chapters.

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ICH publishes Guideline Q13 on Continuous Production

End of July 2022, the ICH (International Council for Harmonisation) published the draft guideline on continuous manufacturing, which had been awaited for two years. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues.

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EMA adopts final Public Statement on Pyrrolizidine Alkaloids

The HMPC adopted the final Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination with PAs. Amongst others, it is stated that PA specifications are no longer considered necessary for essential oils.

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API Testing in the Focus of the Inspections of the U.S. FDA

In May 2021, the U.S. FDA issued a Warning Letter to a Turkish over-the-counter (OTC) drug manufacturer called "Gulsah Uretim Kozmetik Sanayi Anonim Sirketi" due to significant violations of cGMP regulations for drug products.

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Current FDA Requirements for Cleaning Validation

Since the GMP regulations are sometimes not very specific, concrete regulatory guidance on implementation is very helpful. In a current Warning Letter, the FDA specifies their requirements for cleaning validation. What does the FDA require?

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GDP Non-Compliance Report for German Wholesale Distributor: RP is not Continuously Contactable

The competent authority of Germany has entered a new GPD Non-Compliance Report dated 21 July 2021 into the EudraGMDP database due to critical violations of GDP requirements. One of the reasons is that the Responsible Person (RP) does not fulfil the responsibilities personally and is not continuously contactable.

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New MHRA Inspectorate Blog GDP Post: Protecting the UK Medicines Supply Chain

One of the objectives of Good Distribution Practice (GDP) and an important aspect for distributors of medicinal products is preventing falsified medicines entering the legal supply chain. In this context, a new post, entitled "Too good to be true? How to play your part in protecting the UK medicines supply chain" has been published on the MHRA Inspectorate blog.

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European GDP Association publishes new Q&A Document

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The European GDP Association has answered these questions and combined them in a Q&A document.

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FDA sends Warning Letter to Australian OTC Drug Products Manufacturer

The United States Food and Drug Administration (FDA) has recently published a Warning Letter sent to an Australian manufacturer of over-the-counter (OTC) drug products. The Warning Letter summarizes significant violations of current good manufacturing practice (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing.

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EMA and FDA update Principles for Parallel Scientific Advice in the Marketing Authorization Process

Scientific advice and recommendations from regulatory authorities are usually of great benefit for specific medicines in the development phase. The principles for this have recently been updated by the U.S. and European regulatory authorities. Read here how parallel scientific advice from the EMA and the FDA works and what benefits it brings to the approval process.

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FDA Warning Letter due to contaminated Hand Disinfectants

As a result of problems with contamination of hand disinfectants - like with Burkholderia cepacia, a manufacturer in the USA receives a Warning Letter from the FDA.

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System Descriptions in GMP Inspections

As part of inspections the authorities also check computerised systems. Klaus Feuerhelm, former inspector at the Regierungspräsidium Tübingen, has created a TOP 3 list of the most frequent complaints for 2020. TOP 2 of the list - system descriptions. What were the deficiencies found here?

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Batch Documentation: who needs to review?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of a batch. But is the QP obliged to review the batch documentation?

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Clinical Trials: Application of the CTR confirmed as of 31 January 2022

It is official now: the EU Commission has confirmed the full functionality of the Clinical Trials Information System in the Official Journal of the EU. This means that the Clinical Trials Regulation 536/2014 (CTR) will become applicable on 31 January 2022. What are the GMP / GCP changes associated with this?

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What is Similarity?

The EMA published the final reflection paper on "Similarity". The paper shows how statistics should be used in drug development when a comparative assessment of quality attributes (QAs) needs to be made for pre- and post-manufacturing changes, biosimilar development as well as generics´ development.

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FDA Publishes New Near Infrared (NIR) Guidance

Near infrared (NIR) analytical procedures are widely used in the pharmaceutical industry for identification testing and assay measurements and for monitoring and controlling manufacturing processes. In this context, the U.S. Food and Drug Administration (FDA) has published a new Guidance for Industry entitled Development and Submission of Near Infrared Analytical Procedures.

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FDA: Warnings about Side Effects and Contamination with Hand Disinfectants

The FDA is warning against certain hand sanitizers because of side effects and contamination, especially during the COVID-19 pandemic. The latest notifications concern alcohol-based hand sanitizers.

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Warning Letter regarding Insufficiencies Around Access Control

During an inspection the FDA found insufficiencies around access authorization. Read more about remediation activities required by the US FDA. 

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Dealing with Particulate Findings in 100% Visual Inspection

Parenterals must be 100% visually inspected. This is a clear requirement of the pharmacopoeias, just as it is clear that containers with particles must be sorted out. But do the particles found always have to be identified?

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Audit Trail-Deviations in the course of Inspections

Computerised systems are also audited as part of inspections by the authorities. Klaus Feuerhelm, former GMP inspector at the Regierungspräsidium Tübingen, has compiled a TOP 3 list of the most frequent complaints for 2020 based on his inspections. TOP 1 on the list is the audit trail review. What deficiencies were found here?

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FDA Warning Letter Highlights the Importance of Analytical Methods Validation and System Suitability Tests

In a recently published Warning Letter sent to a Chinese company, the FDA criticises, among other aspects, that analytical test methods were not adequately validated and no system suitability requirements were present.

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Medical Cannabis in Malta

Malta´s Medicines Authority issued a document which provides general guidance on medical cannabis production. According to the agency applications for medical cannabis production must be completed and the licence and EU-GMP certificate must be granted before production activities are carried out.

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FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients

The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.

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Nitrosamine Impurities: FDA Rejects the Extension of Deadline for Submission of Risk Assessments

The U.S. Food and Drug Administration has set a narrow window for the submission of risk assessments on nitrosamine impurities for drugs containing chemically synthesised APIs. Read more here about the arguments used by the pharmaceutical industry to request an extension of the deadline and the reasons given by the FDA for rejecting this request.

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