GMP News - Inspections/Audits


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.



FDA's new Quality Metrics Program to plan GMP Inspections

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.



Frequent Findings in Supplier Qualification

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



EMA publishes several GMP Non Compliance Reports

The European Database on GMP and GDP Inspections (EudraGMDP) provides a read-only access for industry. The database is a very useful tool to monitor compliance of suppliers and contract partners. It also contains information about inspection findings. Read more about the latest entries to EudraGMDP.



Managing CAPA and Investigation Processes still in the Focus of Inspectorates

Deviations and CAPA remain hot topics in inspections, as a new MHRA report shows. Read more.



New FDA Inspection Guidance gives the Agency more Power

Some companies delay or deny an inspection or even refuse the inspector to enter. A new FDA Guidance descibes what FDA can do when dealing with uncooperative companies. Read more.



Major Reorganisation at FDA will affect GMP Inspections

The US Food and Drug Administration has informed about a major reorganisation. The FDA has announced plans to introduce a new organisational structure which will become effective on January 2015. Read more about the FDA reorganisation



FDA's New Inspection Data Dashboard

The US FDA has recently introduced a new service on their webpage. A new "inspection dashboard" provides information and analysis about the inspections which have been performed by the FDA in the previous years. Read more in our GMP News.



EU GMP Inspectors find 26 GMP Deficiencies at Chinese API Manufacturer Hebei Dongfeng Pharmaceuticals

EU GMP Inspectors from the competent authority in Romania identified several GMP deviations during a GMP inspection at a Chinese API manufacturer. As a consequence, a GMP Non-Compliance Report has been issued. Read more here about the GMP Non-Compliance Report.



New GMP Non-Compliance Reports available in EudraGMDP

Last month, new GMP Non-Compliance reports were issued for three pharmaceutical companies. The facilities concerned are located in India, Taiwan and Bulgaria. Read more about these new GMP Non-Compliance Reports.



Chinese Company Refuses GMP Inspection and Gets an Import Alert from the FDA

The US FDA has placed the Chinese company Beijing Shunxin Meihua Bio-technical Co on an import alert. Read more here about the FDA Import Alert.


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