Tag: Drug Quality Control

EMA Suspends Picato as a Precaution

EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety. EMA’s safety...

Main Deficiencies in PQS Were Discussed at RegLec-EAEU

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...

WCG Partners with Prudentia for Enhancing Compliance

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...

SID & GP summarized the work carried out over the past year

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'.

FDA Recommendations for Controlling the Risk of Contamination of Blood Platelets

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 ...

Insanitary Condition found in US Warehouse

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...

French pharma company Cristers to use Adents serialisation solution

Adents had its Adents Prodigi cloud serialisation solution chosen by French pharmaceutical company Cristers to ensure compliance with the EU Falsified Medicines Directive (FMD).

EMA published new guideline on the environmental risk of human medicines

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 recalls Amlodipine/Valsartan medicines in the USA

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).

EMA/EDQM inspection found 24 GMP violations at heparin manufacturing in China

pharmaceutical manufacturing
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.

‘SID & GP’ experts attended the VI international forum “Anti-counterfeit 2018...

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).

Valsartan from Mylan Laboratories is prohibited to use in EU medicines

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).

13,000 drugs have already passed through the tracking system in Russia

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.

EMA recommends to restrict the use of fluoroquinolone and quinolone antibiotics

european medicines agency
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics.

Chinese vaccine manufacturer is fined $1.3 billion

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 continue investigating sartan medicines

counterfeit drug
EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management.