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We are often asked about the acceptance of third GMP audits at API manufacturers. The background for this is that more and more organisations offer such audits. Now, the question is what do you have to pay attention to?

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

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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.

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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

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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.

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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).

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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.

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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.

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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.

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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.

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