GMP News

ISO TR 24971 Guidance on Risk Management published

The new ISO TR ISO/TR 24971:2020 Guidance on Risk Management for medical devices has been published last month. This Technical Report provides additional guidance on how to implement a Risk Management System according to ISO 14971.

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FDA Warning Letter: Lack of Lab Data Integrity

Once again, the lack of laboratory data integrity, beside other observations, caused the issuance of a US-American FDA Warning Letter and resulted in deficiencies mainly focused on the solvent recovery processes.

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Pharmacovigilance Audits and Inspections during COVID-19

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes new Q&As relating to pharmacovigilance activities like CAPAs, Audits and Remote-Inspections.

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CHMP's Assessment Report on Nitrosamines published

The recently published final assessment report of the CHMP describes in great detail the state of knowledge on nitrosamines in human medicinal products. All you need to know about risk assessment, calculation of limit values and analysis of nitrosamine contamination can be found in this document.

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Current Developments in Piping Technology: Bending and Passivation

The costs for construction - but also for reconstructions - vary considerably. Tenders for this also often vary considerably. Currently, there are two interesting developments in this area: the increased use of bending machines and the renunciation of chemical passivation. Read more here.

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EMA finalises Guideline on the Use of Pharmaceutical Water

The European Medicines Agency (EMA) has published the final version of its guideline on the use of the different pharmaceutical water qualities. The revision had become necessary due to the possibility to produce WFI using methods other than distillation. Read more here.

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Regulatory Authorities worldwide work more closely together because of COVID-19

Regulatory authorities around the world want to work together more closely on the basis of Covid-19 and have identified three areas for this: research during pregnancy, medicines in clinical trials and monitoring of vaccines. Read more here.

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FDA offers online courses for the pharmaceutical industry

The FDA offers diverse online material as part of their CDERLearn Training and Education Program. A special section contains courses for the pharmaceutical industry.

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Covid-19: Handling of Marketing Authorisations

In order to ensure a smooth and efficient cooperation between the authorities and marketing authorisation holders even in the times of Covid-19, the documentation and templates to facilitate the handling of marketing authorisations have now been bundled, listed and published on the website of the HMA (Heads of Medicines Agencies).

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New Version of the Q&A Catalogue published

In July, new topics were added to the question and answer catalogue "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC".

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New Brazilian ANVISA Guide for the Validation of Computerised Systems

On 14 April 2020, the Brazilian regulatory authority ANVISA published a new guideline for the validation of computerised systems which is to replace the guideline of the same name from 2010. Find out more about the main contents and further developments here.

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FDA Warning Letter due to Lack of Validation of the Aseptic Manufacturing Process

In this Warning Letter from the FDA to a manufacturer of unauthorised tissue-based products, deficiencies in current Good Tissue Practice (cGTP) and violations of fundamental GMP regulations are described. 

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Revised Ph. Eur. Raman Spectroscopy Chapter published for Public Consultation

The European Pharmacopoeia (Ph. Eur.) has published the revised chapter 2.2.48 on Raman Spectroscopy for public consultation. All interested users are encouraged to review the draft and submit their comments from July to September 2020.

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Dissolution Test for Solid Oral Dosage Forms: WHO publishes Draft for Comments

The World Health Organization (WHO) has published a draft proposal for revision in The International Pharmacopoeia. The document entitled DISSOLUTION TEST FOR SOLID ORAL DOSAGE FORMS will be posted on the WHO Medicines website. The deadline for comments is 31 August 2020.

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Pharmacist as new EMA Executive Director

Emer Cooke from Ireland will be the new director of the European Medicines Agency (EMA) in Amsterdam. This was announced by the EMA Management Board.

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Data Integrity - Do Data Flow Diagrams have to be available?

The topic data integrity generates a multitude of questions. Current questions are addressed in a loose sequence of News. Question 9: Must data flow diagrams be available?

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Distant Assessment leads to GMP Non-Compliance Report

The Austrian competent authority has published a Statement of Non-Compliance with GMP to an Austrian manufacturer after a distance assessment. The Manufacturing Authorisation was now revoked.

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Extractable Elements in Plastic Materials - Extended Deadline for Comments

The drafts for the new Ph. Eur. chapters on plastic packaging materials (COP, COC, and Extractable elements in plastic materials for pharmaceutical use) have been re-published in Pharmeuropa to give stakeholders sufficient time to comment.

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Survey results on the Postponement of the Medical Devices Regulation

Due to the Covid-19 pandemic, the EU had decided to postpone the date of application of the Medical Devices Regulation by one year to 26 May 2021. What consequences does this have for the industry?

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New FDA Guide on Inspections of Medical Device Manufacturers

A FDA draft guideline entitled "Review and Update of Device Establishment Inspection Process and Standards" on FDA inspections of medical device manufacturers has now been finalized.

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Is an Update of the QPPV´s Contact Details a Variation?

The CMDh and CMDv recently published a revised version of the Q&A paper regarding variations including a new question on how to notify about an update of the QPPV´s contact details.

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Impact of COVID-19 on EudraVigilance Reporting and Labeling

The European Commission, the HMA and the EMA released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling.

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MHRA and FDA release Joint Paper on Data Integrity in Clinical Trials

GCP Inspectors from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US FDA have published a joint paper on data integrity in global clinical trials.

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Warning Letter to Canadian Manufacturers of Injectable Homeopathic Products

The FDA issued a Warning Letter to a manufacturer of aseptic homeopathics in Canada after the deficiencies listed in a 483 letter sent last October were not satisfactorily addressed.

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New GDP Monograph for Active Substances published

The Good Distribution Practice for Active Substances Guidance on interpretation and implementation has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute.

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