GMP News

Does the FDA expect an assessment for effectiveness after a GMP Training?

Is there an FDA requirement to perform a success control after GMP training? Actually, the answer is no.

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Derogation for Process Validation due to Covid-19

In order to be able to continue to provide the population with high-quality, effective and safe medicinal products during the Covid-19 pandemic, Europe is taking exceptional measures. A Q&A document has been prepared in cooperation between the European Commission, the Coordination Group on Mutually Recognised and Decentralised Procedures (CMDh), the Inspectors Working Group and the European Medicines Agency (EMA). At the end of May, special features for process validation (question 6.2) were added under the heading "GMP Flexibilites".

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FDA Warning Letter to US Drug Maker

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a US-based drug maker for significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the failure to investigate out-of-specification (OOS) test results and to follow proper documentation practices.

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FDA expands Guideline Activities around Gene Therapies

With the publication of six final guidelines on gene therapies and one additional draft guideline, the FDA is further expanding its activities in the area of advanced therapies.

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MHRA´s Expectations during GCP Inspections

The MHRA recently shared their expectations regarding electronic systems used in clinical trials and what they want to see during a GCP inspection.

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Design Qualification from the FDA's Perspective

Is there a specific FDA requirement for a Design Qualification? The answer is (actually) No.

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FDA Warning Letter: Lab Data Integrity still in the Focus

The U.S. FDA issued a Warning Letter to the US American contract testing laboratory “International Trading Pharm Lab Inc” due to significant violations of cGMP regulations and the inaccurancy of electronical data for Active Pharmaceutical Ingredients (APIs).

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Is Cannabis an API, a Herbal Drug or a Herbal Medicinal Product?

The classification defines, among other points, which kind of GMP certification is needed for export / import of Cannabis Flower to the EU and Germany.

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WHO's Pharmaceutical Water Guideline to be revised

The WHO guideline "Good Manufacturing Practices: water for pharmaceutical use" is currently being revised. The WHO issued a draft for public comment in May 2020.

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COVID-19: How to manage temporary GDP Process Changes and Risks

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a post on temporary changes in Good Distribution Practice (GDP) in the MHRA Inspectorate Blog.

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COVID-19: Update of the Q&A document - Validity of GDP Certificates and Wholesale Authorisations

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first revision of the common document "Questions And Answers On Regulatory Expectations For Medicinal Products For Human Use During The Covid-19 Pandemic". The update includes a question on GDP certificates and wholesale authorisations.

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What Marketing Authorisation Holders need to know now about their Registrations

On 10 April 2020, the European Medicines Agency (EMA) together with the Heads of Medicines Agencies (HMA) and the European Commission (EC) published a first version of the document "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", which is continuously updated and adapted.

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WHO Guideline on "Cold" Generation of WFI finalized

In the middle of 2019, the WHO published the draft of the guideline entitled "Production of water for injection by means other than distillation" for the production of WFI by non-distillative methods. This finalised guideline has now been published as Annex 3 in the WHO Technical Report Series (TRS) 1025.

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Update on COC / COP and Extractable Elements in Plastic Materials

Three drafts for new Ph. Eur. chapters on plastic packaging materials have been published for comment in the recent issue of Pharmeuropa: Cyclo-olefin polymers (COP), Cyclo-olefin copolymers (COC), and Extractable elements in plastic materials for pharmaceutical use.

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Postponement of the Medical Devices Regulation - Notified Body Team Statement

With its new Regulation 2020/561, the EU has postponed the beginning of application of the Medical Devices Regulation 2017/745 for one year to May 26, 2021. The Regulation will only be effective after this date. The European Association of Notified Bodies in the Medical Devices sector (Team NB) has now issued a statement on the new regulation.

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IMDRF publishes Guidance Document on Medical Device Cybersecurity

The International Medical Device Regulators Forum (IMDRF) is the succeeding organisation of the Global Harmonisation Task Force (GHTF) in the field of medical devices. The aim of the group is to issue harmonised guidelines. The latest is a guidance document on "Principles and Practices for Medical Device Cybersecurity" from March 2020.

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FDA Feedback after an Inspection at a Medical Device Manufacturer - Update 2020

An FDA draft guideline describes (non-binding) feedback after an FDA inspection of a Medical Device manufacturer. This guideline has now been finalized and was released in April 2020. What changes have been made?

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EMA clarifies Computer Validation and Data Integrity responsibilities in Clinical Trials

The EMA recently published a notice to sponsors which clarifies the responsibilities in regard to the qualification and validation of computer systems and data Integrity in clinical trials.

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USP´s Quality Considerations for Medical Cannabis

The USP Cannabis Expert Panel has published an article on the quality requirements for medical cannabis in the Journal of Natural Products. The article describes the appropriate use of USP General Chapters related to chromatographic methods and controls for contaminants.

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More and more Inspectorates are performing Remote Inspections

TGA has published a media release stating that they have started to undertake "remote and/or hybrid GMP domestic inspections" in place of on-site inspections.

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Audit Trail in the Centre of an FDA Warning Letter

The modification and deletion of electronic data must be documented by an audit trail. A missing audit trail led to a Warning Letter to the Indian company Shriram Institute for Industrial Research.

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New Ph. Eur. Chapter on Essential Oils

The general Ph. Eur. monograph on Essential Oils has been published for comment in the recent issue of Pharmeuropa together with a proposed new Ph. Eur. chapter 5.30. Monographs on essential oils.

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Remote Access to Critical GxP Systems by Service Providers

The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 8: Must there be regulations for remote access by service providers to GxP-critical systems and what data integrity requirements must they contain?

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Fraud in the Supply Chain: Beware of false Offers during Corona Crises

During the current Sars-CoV-2 outbreak, there are sometimes delivery problems with medicines, medical devices and protective equipment. Unfortunately, this also brings up many fraudsters, as a case revealed by Interpol shows.

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