GMP News - Computer Validation


Extensive Warning Letter for Indian Manufacturer of Sterile Medicinal Products - Part 2

Again, the US American FDA has issued a Warning Letter to a manufacturer of sterile medicinal products. Extensive and serious violations of the GMP principles have been discovered at the Indian manufacturer Emcure Pharmaceuticals Limited. Part 2 of this News addresses environment and personnel topics. Read more about the most significant deviations in this Warning Letter.



New FDA Draft Guidance 'Data Integrity and Compliance with cGMP' published

In the last years, the topic "data integrity" has become a priority for the FDA. Recently, the Agency has published the draft of a Guidance for Industry on the topic which presents the comprehensive opinion of the FDA on data integrity. Read more about the draft of the Guidance for Industry "Data Integrity and Compliance with cGMP".



ECA establishes new Interest Group on Pharmaceutical IT Compliance

The ECA Foundation has established various working and interest groups concentrating on different topics. To cover IT technologies with regard to international GMP requirements the Foundation now established a new Interest Group on Pharmaceutical IT Compliance.



New WHO Draft on "Good Data and Record Management"

Data Integrity as a topic has become one of the main focuses of the regulatory authorities. Mid-September, the WHO published a draft guidance for comment on this topic too. Read more about the WHO Draft Guidance on Good Data and Record Management.



The integrity of GMP data - part 2 of the new MHRA blog

In July 2015, the second MHRA blog on the theme of data integrity went live. This time, the focus is on designing systems properly. The ALCOA principles are considered to be very helpful. Read more about the MHRA Good Manufacturing Practice (GMP) Data Integrity blog part 2.



Integrity of GMP Data - New MHRA Blog!

In June 2015 the MHRA, UK, has started an online blog particularly on data integrity. From their perspective the great misunderstanding is that failures with regard to the integrity of data are only caused by deliberate fraud. Read more about the MHRA Blog on Data Integrity.



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.



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.



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.



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.



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.



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



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.



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.



Japanese Requirements on Computerised Systems

Japaneses GMP requirements are defined by the "Pharmaceuticals and Medical Devices Agency - PMDA". Now, a tentative translation of the requirements on Computerised systems into English is available. Read more.


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