GMP News - Validation


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.



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).



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.



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.



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.



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.



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. 



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.



How important is "Data Governance" for your Company?

In August 2016, the PIC/S published the draft of the Guideline "Good Practices for Data Management and Integrity". Here, organisational measures and controls are required to review and assure the effectiveness of the internal data governance system. Read more about the PIC/S requirements for the pharmaceutical data governance systems.



EMA publishes Q&A on Health Based Exposure Limits - Does the 1/1000 dose criterion come again into play in Cleaning Validation?

In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. This publication triggered a discussion about the Permitted Daily Exposure (PDE) values in the Pharmaceutical and even in the API Industry, especially regarding crosscontamination and cleaning validation. Now a draft of a Q&A paper from the EMA provides some concretisation.



EMA revises Process Validation Guideline

A News from March 2014 reported about EMA's revised process validation guideline entitled "Guideline on process validation for finished products - information and data to be provided in regulatory submissions". Now, the EMA has surprinsingly published a new revision of its Process Validation Guideline.



ECA Validation Group: Survey Results

The ECA Validation Group which currently counts 193 members is one of ECA's seven Working/ Interest Groups. We've asked the members of the Validation Group about their topics of interest and in which direction the group should evolve. Find out more about the survey results.



APIC updates its Guidance on Cleaning Validation with regard to the PDE Concept

A news in June 2014 already reported about the APIC "Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Now, a revision has brought the APIC guidance in line with EMA's guideline on "Shared Facilities".



Data Integrity - two new documents from PIC/S and EMA

Data Integrity is one of the hottest topics in regulatory activities at the moment. After the publication of draft documents by FDA in April 2016 and MHRA in July 2016, the PIC/S and the European Medicines Agency (EMA) followed on 10 August 2016 with two new documents. Please find here a short overview of the PIC/S draft PI 041-1 "Good practices for data management and integrity in regulated GMP/GDP environments" and the EMA  "Questions and Answers: Good Manufacturing Practices - Data Integrity".



MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft Version for Consultation

In January and March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published a "GMP Data Integrity Definitions and Guidance for Industry". The agency has recently published a new version of the Guidance. Please find here a short overview of the new features in the "GxP Data Integrity Definitions and Guidance for Industry: Draft version for consultation".


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