GMP News - Validation

14.03.18

New MHRA "GxP Data Integrity Guidance and Definitions" published

On 09 March, 2018, the British supervisory agency MHRA published the final version of its guideline on data integrity which has been available as a draft since July 2016. Find out more on a first analysis of the new document "GXP Data Integrity Guidance and Definitions" .

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14.03.18

Inspectors' Aide Memoire on Process Validation - a Detailed Analysis

With the Annex 15 revision, the issue of process validation became significantly more complicated. What is an authority's view on the topic of process validation?

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07.02.18

How is the Data Governance System to be implemented in your Company?

The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented? Find out more about the requirements and specifications of the PIC/S guideline for the pharmaceutical Data Governance System.

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31.01.18

Regulatory requirements for Audit Trail Reviews

Audit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain. Read more about the EU, PIC/S and FDA requirements concerning Audit Trails and their reviews.

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22.11.17

Data Integrity - Implementation status

Data Integrity deviations are still in the focus of regulators. Nevertheless you will find only general requirements regarding Data Integrity in the GMP Guidelines. More detailed guidelines on Data Integrity are on the way but mostly available as drafts. Get an overview on the current situation and the first implementation steps of Data Integrity activities. 

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08.11.17

Data Integrity from an Inspector's Point of View

Even though the integrity of data has always been one of the basic principles of GMP, the topic has come more and more into the focus in inspections of the last 3-4 years. Read more about an inspector's viewpoint on data integrity.

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30.10.17

FDA criticises Process Validation Deficiencies

In a recent warning letter issued to "Wuxi Medical Instrument Factory", the FDA criticised deficiencies concerning process validation, amongst other things.

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18.10.17

Important Questions and Answers concerning the Audit Trail Review - Part 2

The webinar "Audit Trail Review" took place in February 2017 - with the goal to address the main elements of data integrity and audit trail reviews. During this webinar more than 50 questions were asked. As time did not allow to answer all of them, the webinar's speaker, Dr Wolfgang Schumacher, provided comprehensive answers later. Find out what questions regarding Audit Trail Review were asked and how they were answered.

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27.09.17

FDA criticises missing Step 3 in the Process Validation Cycle

Since publishing the FDA Process Validation Guidance in 2011, the FDA regards process validation as a three-step lifecycle. In a recent Warning Letter, the FDA criticises the absence of step 3 (Continued Process Verification).

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20.09.17

Important Questions and Answers concerning the Audit Trail Review

The webinar "Audit Trail Review" took place in February 2017. Its aim was to address the main elements of data integrity and audit trail reviews. Participants have sent more than 50 questions regarding the webinar which the speaker, Dr Wolfgang Schumacher, has partly answered in writing. Learn more about the Webinar Audit Trail Review and about the corresponding questions asked.

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30.08.17

ECA Validation Group - Update on Activities

The ECA Validation Group was established with the goal to gather knowledge on validation, for example by continuously developing a Process Validation Good Practice Guide. Find out more about what is new in the ECA Validation Group.

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17.05.17

European authorities' viewpoint on validation deficiencies

An article from April reported about the publication of inspection results by the British MHRA for 2016. Amongst other things, this publication addresses deficiencies concerning validation/qualification.

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01.03.17

Quo vadis Cleaning Validation in Annex 15?

In the draft revision of Annex 15 of the EU GMP Guide (Validation / Qualification) there were significant changes in the chapter on cleaning validation threshold determination. Which of these changes will still to be found in the final document? Read on here.

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15.02.17

Serious FDA Warning Letter issued to European Manufacturer of Sterile Drugs, Part 3 - Data Integrity

As a consequence of significant GMP violations, the American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Read more about the details concerning data integrity issues listed in the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd. 

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01.02.17

European Authority's Inspection Findings in the Area Validation/Qualification

The US American Food and Drug Administration (FDA) has long been publishing inspection results in so-called Warning Letters. Those letters are freely available on the Internet. Since a few years now, major violations of GMP have been published in a European inspection database. The British Regulatory Authority (MHRA) does this in a much more detailed way. Read the following examples published by the MHRA on the topic area validation/qualification from 2015.

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