News

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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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.

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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.

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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.

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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.

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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.

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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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The US Food and Drug Administration has initiated a comprehensive new organisation of their inspection activities. One of the key elements of this initiative is the Quality Metrics Program. This program will throw a complete new light on the compliance status of each manufacturing site. Please read more about Quality Metrics in this GMP News.

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Supplier Qualification is a hot topic in inspections. Some examples of observations were published recently by the U.K. authority MHRA. Read more.

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