GMP News - Validation


Qualification Guideline ASTM E2500 revised

The ASTM norm E2500 should provide a modern and alternative approach to qualification. The classical qualification levels DQ, IQ, OQ, PQ are not mentioned anymore but Subject Matter Experts (SMEs) who should take care of the organisation of verification. Moreover, Good Engineering Practice (GEP) is highly valued. The norm has now been revised. Read more 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.



How many Validation Runs are State-of-the-Art today?

For many years the "magical three validation runs" completed successfully were regarded as state-of-the-art in order to be able to define a process as validated. But in the new FDA Guidance on Process Validation no number of validation runs is mentioned any more. How many runs are state-of-the-art today? Read more.



Second Publication of PDA's Technical Report on Process Validation

From time to time the Parenteral Drug Association (PDA) releases so-called "Technical Reports" (TR) on GMP topics. They provide useful and up-to-date information on the respective topic. The newly published Technical Report No. 60 deals with the topic "Process Validation". Read more here.



Validation on the move: How should the Annex 15 of the EU GMP Guide be revised?

Together with the EMA Process Validation Guideline the Annex 15 should also be revised. A very vague concept paper is available which the EMA is requesting comments for. Now we would be interested in finding out what your thoughts are with regard to the planned revision. For that purpose the ECA has prepared a brief questionnaire. Read more.



Where can Indications on the Riboflavin Test be found? Are there any alternatives?

In the context of cleaning validation reference is often made to the riboflavin test when it comes to wettability and spray shadows. But how is the test carried out exactly? Are there any alternatives to this test? Read more.



PDA publishes Technical Report on Cleaning Validation

At random intervals the Parenteral Drug Association (PDA) publishes so-called "Technical Reports" (TR) concerning GMP topics. They are a potential source to get more information on the state of the art concerning the respective topic. The PDA published the Technical Report No 29 on "Points to Consider for Cleaning Validation" as early as 1998. This report has now been published again in an updated version. Read more.



EMA publishes Concept Paper on the Revision of Annex 15

In November 2012, the EMA released a Concept Paper of 3 pages on the revision of Annex 15. The introduction presents the reasons why the EMA has planned the revision, Read more here.



ECA publishes Good Practice Guide on Process Validation

An ECA Working Group has developed a Version 1 of a Good Practice Guide on Validation. This document is intended to provide support to both regulators and industry. Go here to read more.



FDA Warning Letter Statistics 2011 with regard to Process Validation / Qualification and Calibration

In the Warning Letter Report 2011, statistics have been published about FDA’s Warning Letters (issued to drugs and API manufacturers) during the fiscal year 2011 (from October 2010 to September 2011). The topics Process Validation / Qualification haven’t been considered separately. In the following, you will find a summary from the 39 Warning Letters 2011 on GMP deviations regarding Process Validation, Qualification and Calibration in the manufacturing environment.



ISPE Guide bridges traditional Qualification and risk- and science-based Qualification

In last week's news we talked about an ISPE Mapping Document that illustrates relationships to other ISPE Guides on qualification. One of these ISPE Guides, the ISPE Good Practice Guide "Applied Risk Management for Commissioning and Qualification" is used as bridge in order to connect traditional qualification approaches according to ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&Q) to a modern risk- and science-based qualification approach. Read more.



ISPE Mapping Document explains Relationship between different Qualification Guides

The ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&G) has been available since 2001. Now, an ISPE mapping document explains the relationship between the ISPE Baseline Guide Volume 5 and the new ISPE Guide "Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment" (FSE Guide). The mapping document also presents an ISPE Guide (Applied Risk Management Guide) which has the function of a "bridge" between these two documents. Read this news to get an overview of this "Mapping-Document for ISPE Specification and Verification Guides" that explains the relationship of different ISPE Guides with regard to qualification.



Actual GMP Deficiencies concerning Validation/Qualification/Calibration as seen by the MHRA

In our news from 4 July 2012 we reported on a publication on the results of inspections carried out by the MHRA (Medicines and Healthcare Products Regulatory Agency, MHRA). It is worthwhile to take a look at this publication also beyond the actual top ten list of deficiencies, since there are relatively few publications on GMP deficiencies by European authorities. The following observations focus on the topics process validation/equipment qualification/calibration.



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.



FDA Warning Letters relating to Computerised Systems

Problems in connection with computerised systems have also been addressed in two actual FDA Warning Letters. Read more here.


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