The topic of the pharmaceutical quality system being an integral part of the entire drug manufacturing process, the peculiarities of its implementation and data integrity were discussed at the «RegLec...
Aims to deliver a comprehensive solution aimed at enhancing the quality, safety and regulatory compliance of adverse event monitoring in drug development.
The WIRB-Copernicus Group's (WCG) Clinical...
The results of the work by the GMP-inspectorate became the main topic of the meeting with representatives of the top Russian mass media held by the Director of the FSI 'SID&GP'.
With the current document "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion", the FDA ...
The U.S. Food and Drug Administration announced that, on behalf of the agency, the U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held under insanitary co...
Adents had its Adents Prodigi cloud serialisation solution chosen by French pharmaceutical company Cristers to ensure compliance with the EU Falsified Medicines Directive (FMD).
The European Medicines Agency (EMA) has published a iconrevision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation.
Teva Pharmaceuticals has initiated a voluntary recall in the USA due to an impurity detected in an active pharmaceutical ingredient (API) manufactured by Mylan (India).
The inspection identified 24 GMP deficiencies and seven were categorized as major. The extraction of substance, physical processing and packaging and biological testing were found to be noncompliant.
The representatives of the State Institute of Drugs and Good Practices of Minpromtorg of Russia took part in the International Forum «Anti-counterfeit 2018» in Moscow (Russia).
Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad (India).
The functions of the operator of the information system for monitoring the movement of drugs were transferred to the Center for the Development of Advanced Technologies.
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics.
Chinese manufacturer of rabies vaccine was fined 9.1 billion yuan ($1.3 billion) for falsifying production records in a scandal that prompted a nationwide crackdown on the industry.
EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management.
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