News

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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Current FDA's Warning Letters on IT Topics - Part 1: Medical Devices

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 more.

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FDA Guidance for Industry: Electronic Source Data in Clinical Investigations

The FDA published its new Guidance for Industry (GfI) - "Electronic Source Data in Clinical Investigations" in September 2013. The Guidance defines the expectations of the FDA concerning electronic source data generated in the context of clinical trials.  Find out more about this Guidance.

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ISPE GAMP R&D and Clinical Systems SIG publish first Concept Paper

When changing from paper-based to computerized systems and processes in the field of Good Clinical Practice (GCP), validating these systems is of critical importance, as inspectors are increasingly focussing on this facet of clinical trials. The ISPE GAMP R&D and Clinical Systems SIG has published a Concept Paper on the application of GAMP 5 validation principles to the GCP field.  Read more here about the Concept Paper

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1997 - 2003 - 2013: Quo vadis 21 CFR 11?

What is the current status concerning US 21 CFR Part 11 - Electronic Records, Electronic Signatures? 16 years after the release of the regulation and 10 years after a period of intensiv discussion you can read a short  summary about the situation today. To read more see here.

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FDA Guidance for Industry on Validation of Blood Establishment Computer Systems

Blood establishments use different and very specific computer systems. The FDA's new Guidance for Industry "Blood Establishment Computer Systems Validation in the User's Facility" published in April 2013 takes into consideration the particularities and validation approaches of such computerised systems. Read more here.

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