GMP News

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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2-Step Process for Implementation of Pharmacopoeial Procedures

A new Ph. Eur. draft chapter 5.26 proposes a two step implementation process for the use of pharmacopoeial procedures.

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Drug Shortages: a European Solution at Last?

The European Parliament wants the European Union to become more independent with regard to pharmaceuticals and medical devices. A report on this has now been developed and adopted.

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What happens when Product is delivered before Release?

A Warning Letter was sent to a company who shipped product without a release.

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Nitrosamine Impurities in Medicinal Products and APIs - the New FDA Guidance

The new FDA Guidance for industry reflects the current state of knowledge regarding nitrosamine impurities. Read more here about what measures the FDA expects from medicinal products and API manufacturers to take to mitigate the risk of nitrosamine contamination.

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Deficiencies in Media Fills and Smoke Studies: Warning Letter

A US-American pharmaceutical manufacturer was inspected by the FDA in February 2020. Due to serious deficiencies in the media fills and smoke studies in the aseptic area, the manufacturer has now received a Warning Letter.

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Inspection Report: What Inspectors are looking for

Roughly 10% of deficiencies raised by MHRA inspectors were directly attributable to poor investigations. So what do inspectors observe?

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What are FDA's Requirements for Pharmaceutical Quality - YouTube Videos give Answers

The FDA presented its requirements for pharmaceutical quality, including quality assurance aspects in a webinar. This webinar focused on stakeholders in the pharmaceutical supply chain worldwide. The presentations are available as YouTube videos.

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Herbal Medicinal Products: HMPC's Statement on Pyrrolizidine Alkaloids

The Herbal Medicinal Products Committee (HMPC) of the EMA has published the draft of the updated public statement of the HMPC on pyrrolizidine alkaloids (PAs). The document contains, among other things, the limits for the maximum daily intake of PAs.

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British Authority Criticizes Insufficient Prevention of Cross Contamination

The British health authority MHRA has recently published a statement in its blog, which reports about insufficient measures to avoid cross contamination in multipurpose facilities. This has been noticed in recent inspections.

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Medical Device Warning Letter Statistics for the first Half of the Fiscal Year 2020

The ECA regularly provides you with analyses of the deficiencies in FDA Warning Letters regarding medical devices. In the comparable period of the years 2017, 2018 and 2019 (1 October - 30 September), we mentioned the noticeably low number of Warning Letters. This trend is also evident for the first half of the fiscal year 2020 (1 October 2019 - 31 March 2020). Learn more about the top 3.

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FDA Feedback on Combination Products

There is a draft guideline on combination products describing the ways in which a sponsor can communicate with the FDA during the development of a combination product. What does it say?

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Marketing of Medical Devices in the UK after the Transitional Period

The UK Medicines and Healthcare Products Regulatory Agency MHRA has published a guide the marketing of medical devices after the transitional period in the UK.

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Eurasian Pharmacopoeia Available

The Eurasian Economic Commission published Volume 1 of the EAEU Pharmacopoeia. This Volume contains 157 general texts and general monographs.

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