Guidance: How to handle temporary Changes in the Quality System
A new Q&A Document gives guidance for temporary changes to certain scheduled quality related tasks and deferral of certain routine operations.
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.
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".
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.
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.
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.
New Chapter in the European Pharmacopoeia on Multivariate Statistical Process Control
In our News dated 19.08.19, we had mentioned the draft of a new Ph. Eur. chapter (5.28) regarding Multivariate Statistical Process Control. This chapter has now been adopted and will be published in the October 2020 issue.
Design Qualification from the FDA's Perspective
Is there a specific FDA requirement for a Design Qualification? The answer is (actually) No.
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).
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.
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.
Annual OMCL Network meeting focuses on role of OMCLs during the COVID-19 pandemic
The annual meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 12 to 15 May 2020, online and with a reduced programme due to the COVID-19 crisis. It was attended by more than 350 participants from 39 countries and was organised by the EDQM.
20th edition of the EDQM Blood Guide now available
The EDQM, Council of Europe, has just released the 20th edition of the Guide to the preparation, use and quality assurance of blood components (also known as the Blood Guide).
Guidance for medicine developers and companies on COVID-19 (updated)
COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
EMA is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the serious side effects that can result from treatment with these medicines.
Referral: Cyproterone-containing medicinal products , cyproterone , Article 31 referrals, Position provided by CMDh, 25/03/2020, 20/05/2020 (updated)
Periodic safety update single assessment: Ambroxol : List of nationally authorised medicinal products - PSUSA/00000130/201909 (new)
Periodic safety update single assessment: Ambroxol / clenbuterol: List of nationally authorised medicinal products - PSUSA/00000131/201909 (new)
Periodic safety update single assessment: Aminosalicylate sodium: List of nationally authorised medicinal products - PSUSA/00000165/201910 (new)
Human medicines European public assessment report (EPAR): Olanzapine Apotex, olanzapine, Schizophrenia, Bipolar Disorder, 10/06/2010,, 10, Authorised (updated)
Periodic safety update single assessment: Atenolol / chlortalidone: List of nationally authorised medicinal products - PSUSA/00000260/201909 (new)
Periodic safety update single assessment: Valsartan / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010735/201910 (new)
Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic.
FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Product
The U.S. Food and Drug Administration is announcing today that agency laboratory testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several lots of the extended-release (ER) formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes.
EUROPEAN MEDICINES REGULATORY NETWORK FULLY MOBILISED IN FIGHT AGAINST COVID-19
The development and availability of medicines and vaccines for all patients in the European Union, including those with COVID-19, is the number one priority for the European medicines regulatory network.
Press release ICH Assembly virtual meeting, May 2020
The International Council for Harmonisation (ICH) met virtually on 27 May, in place of the face-to-face meetings that were to take place in Vancouver, Canada. The meeting was preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee. ICH’s Working Groups have also been progressing their activities virtually...
Resolução do Conselho de Ministros n.º 40-A/2020 - Diário da República n.º 105/2020, 1º Suplemento
Prorroga a declaração da situação de calamidade, no âmbito da pandemia da doença COVID-19.
Comunicado de Imprensa - Infarmed e DGS recomendam suspensão do uso de hidroxicloroquina em doentes com COVID-19
O INFARMED, I.P. e a Direção-Geral da Saúde (DGS) decidiram recomendar a suspensão do tratamento com hidroxicloroquina em doentes com COVID-19. Esta decisão está em linha com a decisão da Organização Mundial de Saúde (OMS), na sequência da publicação de dados que questionam a segurança e a eficácia deste medicamento.
Building on the European Commission’s Roadmap for the EU Pharmaceutical Strategy
EFPIA welcomes the European Commission’s recognition of the importance of the pharmaceutical sector in the Pharmaceutical Strategy and looks forward to working with the EU institutions and Member States to building Europe’s health research eco-system, increasing our resilience to global health threats and driving our economic recovery.
Commission launches second-stage consultation of social partners on fair minimum wages in the EU
Today, the Commission launches the second-stage consultation of European trade unions and employers' organisations on how to ensure fair minimum wages for all workers in the European Union.
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