GMP News - Inspections/Audits


Non Compliance Report in Radiopharmaceutical Manufacturing

The Italian Medicines Agency published a "Non-Compliance Report" on radiopharmaceutical manufacturing and a suspension of the manufacturing authorisation.



Has GMP Inspection Report of Slovenian GMP Inspectors caused FDA and Health Canada Import Alerts?

In March 2015 the Slovenian GMP Inspectors have conducted a GMP Inspection at the company Polydrug Laboratories PYT. LTD. in Maharashtra, India. Now it seems that both Health Canada and the US FDA have used the GMP inspection report of the Slovenian Authority to decide on consequences for supplies to Canada and the US. Read more about the compliance actions taken against Polydrug.



WHO issues GMP Non Compliance Statement to India based Svizera Labs

After FDA and EU have raised concerns about Good Manufacturing Practice implementation at a number of Indian companies, now the Word Health Organisation (WHO) also found serious GMP deviations. The company Svizera Labs located in Mumbai, India, received a Notice of Concern - a letter similar to the FDA Warning Letters. Read more about the WHO Letter of Concern to Svizera Labs



FDA Inspection Reports: What is What

Repeatedly we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). There are three main documents.



FDA 483s and Responses available in the World Wide Web

Everyone can now review 483s, 483 responses, Consent Decree Correspondence and other interesting documents in an Electronic Reading Room of the U.S. Food and Drug Administration (FDA).



FDA Warning Letter on Data Integrity

The integrity of data is currently in the focus of international authorities. In particular the US FDA issued serious violations in Warning Letters to the companies concerned. Read more about the current complaints in a Warning Letter issued to the API manufacturer VUAB Pharma.



Aseptic Manufacturing Operation: Chinese Company Zhuhai United Laboratories does not comply with EU GMP

While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are in the spot light. On 15 June 2015 the National Agency for Medicines and Medical Devices of Romania entered a GMP Non-Compliance Report for Zhuhai United Laboratories into EudraGMDP. Read more about the GMP deviations observed at Zhuhai United.



Another Indian API Manufacturer found to be out of GMP Compliance by EU Authorities

India continues to be the place were many manufacturing sites are found to be out of GMP compliance. This time POLYDRUG LABORATORIES was inspected and 17 GMP compliance violations were found. Read more about the GMP-Non Compliance Statement.



Is it possible to ask the Authorities for a voluntary Inspection of an API Manufacturer?

Can an API manufacturer ask for an inspection to receive an EU GMP certificate? This is answered in the Question and Answers section of the EMA together with a question regarding the obligation to audit.



New comprehensive GMP Inspection Database available

Just recently a so called "inspection tracker" was launched by Health Canada. Now, the agency offers an additional database which contains 3,821 inspections (per March 2015) which have been performed since 2012 - many of them outside Canada, e.g. in Europe or Asia. Please read more about the GMP Inspection database.



Data Integrity - Again Import Alert issued for Indian company IPCA

Data Integrity has become one of the most important GMP compliance issues in the past two years. This has enormous consequences for the concerned companies but also for companies and authorities in EU and US.  Again the US FDA has identified a company that violates regulations and put patients at risk. The company IPCA was already known for not meeting the GMP requirements. Read more about the GMP findings at IPCA and the consequences for companies and authorities dealing with Indian partners.



FDA plans a new approach to facility inspections

The "FDA Voice" is a Blog which has been developed by the US Agency to post current initiatives, presentation and views. In a recent post published on March 24, 2014 Howard Sklamberg and Cynthia Schedar discuss ideas to improve the quality of inspections. Read more about the new FDA inspection appraoch.



Pre-Inspection Compliance Documents published by MHRA

The MHRA has published a revised set of documents which are part of the risk based inspection system of the GMP Inspectorates in the UK. These documents are intended to help MHRA to get information prior to an inspection. Please read more about the MHRA risk ranking and the required Reports.



New Website about GMP-Non-Compliance Statements

Information about manufacturing sites that are out of GMP compliance is urgently needed. In a globalized world manufacturing is no longer located in the market where the medicinal products are sold. Health Canada is the next authority which reacts on the need for information to identify companies and sites that do not meet GMP standards. Read more about the GMP Inspection Tracker.



Warning Letters in Fiscal Year 2014 - "Compounding Pharmacies" are Targets of the FDA

A large part of the Warning Letters sent by the FDA in fiscal year 2014 was addressed to "compounding pharmacies". Against this background, the statistics of the most frequent deviations highlight other focuses. Read more here.


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