News

Track&Trace - IT Implementation ordered by European Pharmaceutical Associations

The "European Medicines Verification Organisation" (EMVO) has developed a model for the practical and cost effective implementation of the system for data storing and has also signed framework agreements with three partners. Find out more about the EMVO model.

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Data Integrity - Indian Government puts EU under pressure

One of the largest scandals with regard to data integrity and data manipulation has been detected by French Inspectors of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) in India. But the government in India will not accept the finding.  Read more about the data integrity and data manipulation issues observed at GVK and the consequences.

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MHRA revises its Guideline on Data Integrity in the short Term

The MHRA revised their Data Integrity Guidance in the short term. Read in this news what the current "GMP data integrity definitions and guidance for industry" requires with regard to the GMP compliant handling of data and records.

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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.

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Data Integrity: New Inspection Focus of the FDA

Reviewing data integrity is FDA's new inspection focus. Concerning this, new requirements in form of questions and answers have been added to FDA's Q&A webpage on Current Good Manufacturing Practices. Also the recent Warning Letters indicate a clear focus on the data integrity topic. More information can be found here in the News.

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GMP Data Integrity: New MHRA Guideline

In January the MHRA, UK, published a Guideline on data integrity in the GMP environment. Now, a data governance system for data in the GMP manufacture and analytical laboratories is required in addition to the existing quality systems. More information can be found here in the News.

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Warning Letters on Data Integrity: What does the FDA expect from Third Party Auditors and Consultants?

Again and again, Warning Letters keep on reprimanding GMP-violations of the handling of electronic data. In some cases, the FDA urgently recommends the support of an external consultant. Read more here about what FDA's expectations regarding consultants are.

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What are the EU GMP Requirements for the Validation of Excel Spreadsheets?

Everyone uses Excel Spreadsheets. Also in pharmaceutical companies, Excel Spreadsheets are used in different departments. But what are the EU GMP requirements for the templates. Read more in our GMP News about Excel Spreadsheets.

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Current FDA's Warning Letters on IT Topics - Part 2: Finished Medicinal Products and APIs

In cases of serious deviations from the GMP requirements, the US FDA issues Warning Letters to the companies concerned. In some current Warning Letters from 2014, significant GMP deficiencies with regard to IT topics can be found. Read on.

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MHRA's Guidance for Software as a Medical Device (including Apps)

The British MHRA (Medicines and Healthcare Products Regulatory Agency) has published a guidance for developers of "software as a medical device"  = "stand-alone software". The text also expressly addresses "apps". Get the details here.

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