Tag: GMP inspection

SID&GP and Thai FDA Agreed to Conduct Joint Inspection

On August 15, the meeting between national GMP-inspectorates took place at the Russian-Thai Business Forum venue, organized by the Ministry of Industry and Trade of the Russian Federation. Thai FD...

GILS and NP Presented Overview of Results of Inspections of Foreign Medicines’ Manufacturers

sid&gp
Director of the Federal State Budgetary Institution “GILS and NP” of the Ministry of Industry and Trade of the Russian Federation Vladislav Shestakov presented, within the framework of the 20th annive...

Pharma Company Planned to Shred Quality Control Records before FDA Inspection

An Indian pharmaceutical company attempted to dispose of quality-control records a week ahead of a US Food and Drug Administration (FDA) inspection, found FDA officials. Documents were found awaiti...

EU and US Fully Implemented MRA for Inspections of Manufacturing Sites

With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspection...

Joint GMP Inspection of the Eurasian Economic Union Inspectorates

On 18-20 June a joint pharmaceutical inspection of the Eurasian Economic Union inspectorates, organized within the Working Group on formulating common approaches in regulation of drugs circulation wit...

How to Read Indefinite Legal Terms of GMP Regulators

The GMP regulations are "bombarded" with indefinite legal terms. Things should be appropriate, regularly repeated, or sufficient. To be precise, this can also be found as a requirement in the EU GMP G...

EC Published New Aide-Memoire for GMP Inspections

Back in 2011, the European Commission (EC) published Directive 2011/62/EC, the so-called Falsified Medicines Directive (FMD).The main goal was to support the fight against counterfeit medicines. The n...

What to Expect from Russian GMP Inspection

Although the idea and content of GMP guidance in different countries or regions is quite comparable, there are no common global GMP regulations - and inspectors from various national competent authori...

FDA Found Violations of cGMP in Canadian OTC Manufacturer Facility

FDA sent a warning letter, dated May 7, 2019, to Petra Hygienic Systems International, LLC after an inspection of the company’s Concord, Ontario facility found violations of current good manufacturing...

FDA to accept GMP inspections from Bulgaria and Cyprus

eu-us
In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level e...

Typical PQS Deficiencies Found at Drug Manufacturers: What Does a GMP Inspection Focus On?

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 this day at th...

WuXi STA Passed First GMP Inspection by MPA

STA Pharmaceutical Co., Ltd., – a subsidiary of WuXi AppTec – announces that its new drug product manufacturing facility in Shanghai Pilot Free Trade Zone has passed its first GMP inspection by the Eu...

Two More Countries in EU-US Agreement of GMP Inspections

In February 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a leve...

Russia to Inspect British Pharma Manufacturers

The Russian Ministry of Industry and Trade’s State Institute of Drugs and Good Practices plans to inspect five British pharmaceutical manufacturers for compliance with GMP standards in 2019. That’s ac...

FDA Commented Recalling Lots of Blood Pressure Drugs

The US agency has said a problem with the manufacturing process is the likely source of contaminants. The recall of hundreds of lots of contaminated blood pressure drugs last summer has been the su...

SID & GP Organized Workshop about GMP Requirements

At the end of December, experts of the State Institute of Drugs and Good Practices of Minpromtorg of Russia held an open expert-advisory workshop «Requirements and application of GMP rules for API man...