GMP NEWS 2020

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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FDA Warning Letter for Canadian Drugmaker - HPLC and Data Integrity in the Focus

The U.S. Food and Drug Administration (FDA) has recently published a Warning Letter to a Canadian over-the-counter (OTC) drug producer. During an inspection, the FDA found significant violations of current good manufacturing practice (CGMP), including data integrity issues related to HPLC analysis.

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Publication of the WHO Document on Limits in Cleaning Validation

The issue of (cross-) contamination and, in this context, cleaning validation have played an important role in the GMP environment for decades. For some years now, health-based exposure limits have been added as a possible alternative. In a draft guideline, the WHO has addressed this topic.

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Pharmaceutical Associations underline Importance of MRA with UK

Several European pharmaceutical associations are calling on the EU to give priority to access to medicines in the ongoing Brexit negotiations. Specifically, they are calling for an MRA.

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CEPs: What Applicants and Authorisation Holders should know!

Due to the corona pandemic, many processes and regulations are currently in change - information regarding the current procedures for applying for CEPs is listed on the EDQM website.

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CMDh: Update of the Q&A List Variations

The Q&A document on variations entitled "Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008" of the CMDh and CMDv was updated again in May 2020.

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Q&A paper of EMA, EC and HMA updated once again

Again, the catalogue with "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" issued by the EC, HMA and EMA has been updated. It now includes the facilitated handling of existing marketing authorisations together with the handling of marketing authorisation procedures in times of Covid-19.

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MRA: 25% less FDA Inspection in the EU

In 2019 the US Food & Drug Administration FDA was able to reduce 25% of routine surveillance inspections in the European Union, as reported by the authority.

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