GMP News - Validation


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



Validation - Revision of Annex 15: Industry's "problems" - Results of an ECA Industry Survey

With the publication of a draft on the revision of Annex 15 at the beginning of February 2014, movement was brought into the GMP requirements on validation and qualification - also in Europe. Changes attributable to revision of Annex 15 should not be underestimated. The European Compliance Academy (ECA) has carried out a survey and determined how industry assesses these possible changes and which uncertainties exist concerning the revision draft. To get a conclusion on the analysis of the survey read this news.



WHO publishes Draft on Process Validation

Dated April 2014 the WHO published a proposal for the revision of appendix 7 (non-sterile process validation) as a supplementary to the Guidelines on Good Manufacturing Practices. The reason given for the revision is compliance with actual GMP requirements. The following is an in-depth analysis.



EMA issues Draft Guideline on Process Validation for Biotechnological Products - an Analysis

In the GMP Newsletter last week we already reported about the EMA Draft Guideline of Process Validation for biotechnological products. To get a more detailed analysis please see this news.



EMA publishes Guideline Draft on Validation of biotechnology-derived Products

For the EMA, it was necessary to develop an independent guideline on the topic as - despite the existence of harmonised ICH documents - specific aspects of the validation of biotechnology-derived products have been missing. A draft is now available.



Is the end of the periodic revalidation coming with the revision of Annex 15?

The planned revision of Annex 15 doesn't provide for a periodic revalidation any more. Can it therefore be dropped in the future? The following is an overview of the actual requirements concerning the periodic revalidation or its possible cancellation.



Planned Annex 15 Revision: What Changes are really new in the Chapter on Cleaning Validation?

The number of sub items addressed in the chapter on cleaning validation regarding the revisions of Annex 15 has doubled. But what is really new? Get the answer here. 



Annex 15 Survey: Take your Chance and comment the Draft Revision

The EU GMP Guide Annex 15 was originally published in 2001. At the end of October 2012, the EU has announced to revise it. Now the draft for the revision of Annex 15 is published. All in all there is an abundance of new requirements. Some new terms ar a bit "nebulous" and the whole document seems to be a little "spongy". Therefore, the ECA has set up a survey to get a feedback from the pharmaceutical industry. A summary of the feedback will be forwarded to the EU Commission and will also be published as news. Read more.



Detailed analysis of EMA's new Guideline on Process Validation

It didn't really come as a surprise that EMA published its revised Guideline on Process Validation on 27 February 2014 after the publication of the draft on the revision of Annex 15 at the beginning of February. EMA had announced the revision in a concept paper already a long time ago. Read in the following a detailed analysis of the Guideline on Process Validation.



EMA publishes New Process Validation Guideline

After the publication of the Annex 15 draft at the beginning of February 2014, the EMA made a move towards the revision of its process validation guideline. The final document was published on 27 February 2014. For a long time now, the EMA had already announced this revision in a concept paper. What's new?



Revision of the EU GMP Annex 15 for Qualification and Validation published

The EU Commission has published the revision of the GMP Annex 15. Compared to the currently valid version the document has been revised extensively. Read more about the most important changes.



FDA Warning Letter Statistics 2013 with regard to Process Validation / Qualification / Calibration

In previous GMP News, we presented FDA "Findings" in the complex topics validation / qualification / calibration in manufacturing with regard to medicinal products. Read the News to get the analysis of the 37 Warning Letters.



Cleaning Validation Requirements in Asia

Since the nineties, cleaning validation has been one of the main validation topics discussed by the pharmaceutical industry and API manufacturers. Because of growing globalisation, countries in East Asia (Tiger States and Panther States) have also become interesting as consumer countries of APIs and/ or medicinal products. What about requirements on cleaning validation there? Read more here.



FDA publishes Guideline Draft on the Registration of Production Sites

In our News from 11 September 2013, we reported about FDA's initiative to identify production sites according to a  uniform system. The topic seems to be crucial for the FDA as it has now released the draft of a "Guidance for Industry" entitled ... Read on.



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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