GMP News

FDA Guidance for Industry concerning Wholesale Distributor Verification Requirement for Saleable Returned Drug Products published

The U.S. Food and Drug Administration (FDA) has published the final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies".

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Swissmedic publishes Information concerning an official Warning from Brazil regarding Falsified Medicinal Product

The Swissmedic has been informed by the Brazilian Health Regulatory Agency ANVISA that Brazil has suspended all imports of medicinal products from three Turkish wholesalers. In this regard, an information for Swiss companies was published.

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Warning Letter to Indian Manufacturer: Dead Legs and Missing Validation

Due to the deficiencies identified during an inspection that the FDA had already conducted in February 2020, an Indian pharmaceutical manufacturer has now received a Warning Letter. The main reasons for this were deficiencies in equipment design, validation and incoming goods inspection. Read more here.

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Brexit: MHRA updates Guidance

MHRA has issued/ updated a set of guidance documents for UK companies, which will also have impact on EU companies supplying medicines into UK.

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FDA and Design Qualification

The term Design Qualification is not used in the current FDA Guidance on Process Validation. However, it is addressed that the design of a facility plays a role within the scope of a qualification. Moreover, in a current Warning Letter the FDA criticizes design deficiencies in a water system.

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How to Demonstrate GACP-Compliance?

The requirement for a "written GACP declaration" is contained in the current draft of the EMA HMPC Guidance Document "Quality of Herbal Medicinal Products". However, some questions remain: Who creates the declaration and what does it look like?

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Track and Trace: What to do with Recalls?

When complying with the requirements of the Anti-Counterfeiting Directive, the status message "recall" for recalled batches is of great relevance for the entire supply chain. What has to be considered here?

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Can Cannabis be Imported into the EU without GMP Certification?

The answer to this question is: It depends. Recently, medical cannabis grown in a non-EU-GMP-certified facility in Uruguay became available on the German market.

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MHRA joins Consortium of Regulators - without EU

The British MHRA has joined an Australia-Canada-Singapore-Switzerlan Consortium to explore opportunities for information and work-sharing.

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Pyrrolizidine Alkaloids: USP Proposal for Contaminant Analysis

In addition to the new USP Chapter <1567> Pyrrolizidine Alkaloids announced recently, the USP is proposing a new chapter entitled <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs).

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Warning Letter for US Repacker: Deficienceis in Cleaning and Stabilities

A repacker in the US has recently received a Warning Letter from the FDA. The described deficiencies are repackaging of products in non-equivalent primary packaging, the lack of cleaning validation and the establishment of a suitable quality unit.

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Q&As Cleaning Validation - Part 2

In last week's newsletter you could read about part I of Q&As on cleaning validation - asked during ECA's first Cleaning Validation Online Training Course in September. The ECA would like to share a selection of these Q&As on Cleaning Validation - now in part II.

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GMP Deficiencies in Packaging

A US-American pharmaceutical manufacturer has recently received a Warning Letter from the FDA due to deficiencies in packaging and quality assurance.

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CSA (Computer Software Assurance) - Position Paper from GAMP Francophone

About 2.5 years ago, the FDA announced a Guidance for Industry on Computer Software Assurance (CSA). However, this guidance has not yet been published. Currently, GAMP Francophone has published a first position paper on this issue.

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Q&As Cleaning Validation - Part I

In September the ECA offered the first Cleaning Validation Online Training Course - with many questions for the speaker. The ECA would like to share a selection of these Q&As on Cleaning Validation with the community.

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Audit Alternatives of Notified Bodies in Covid-19 Times

Due to the Covid-19 pandemic, on-site audits by Notified Bodies are partly only possible to a limited extent or not at all. What are the alternatives? A guideline of the Medical Device Coordination Group (MDCG) provides information on this.

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FDA Publishes Catalog of Tools for the Development of New Medical Devices

Medical devices are essential medical tools and that is why health authorities are also interested in their development. For this purpose, the FDA has presented a catalog of tools for the development of medical devices.

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Reprocessing of Medical Devices - Implementing Regulation for Single-Use Devices

The reprocessing of single-use devices in the medical device sector is left to the EU Member States. However, only the national law of the respective member states must allow this. Now, an implementing regulation is available which describes common specifications for reprocessing single-use devices.

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How does an Authority react if no Process Validation is available?

A successfully completed process validation is one of the basic GMP requirements for a product to be marketed. So, how does an authority react if a product is already on the market but no process validation has been carried out? The FDA provides answers in a current Warning Letter.

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Free Access to FDA 483s

FDA's Office of Regulatory Affaires (ORA) is publishing electronic copies of various inspection and related records on their websites.

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How Extensive is GMP and GDP Training in the Pharmaceutical Industry: Survey Results

In the course of a survey in the GMP/GDP environment, about 200 questionnaires were filled out. The aim of the survey was to record the current status of the implementation of GMP/GDP training measures in the pharmaceutical industry. Read more here about the results of the survey on GMP/GDP training.

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Version 18 of the Q&As on Safety Features for Track & Trace

The European Commission has published the 18th version of the "Questions & Answers" on safety features.

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ECA GDP Association represented at 5th Annual International GDP Conference in Serbia

The "5th Annual International Conference - Good Distribution Practice" organised by the Quality Association of Serbia was held in Belgrade, Serbia on 26th September 2020. The Director of Regulatory Affairs and Communications, Prabjeet Dulai, was invited by the Program Committee to represent the ECA GDP Association and give the introductory session, aptly titled "The Power of Building Relationships - role of the European GDP Association."

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Brexit: Acting as a Responsible Person (import) (RPi)

The Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a Guidance called "Acting as a Responsible Person (import) from 1 January 2021". The guidance describes the role of the Responsible Person (import) (RPi) and how to become a RPi.

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FDA clarifies "Intended Use"

The U.S. FDA revised the text of their "intended use regulation" to provide additional examples and explanation. In particular clarity is provided by describing examples of types of evidence the agency would consider relevant to determining the intended use of a product. 

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