New EMA Guideline on the Investigation of Bioequivalence

The European Guideline on the Investigation of Bioequivalence came into effect on 1 August 2010. Further details can be reviewed here.


FDA Inspection Reports: What is what?

We are asked about the different inspection reports of the US-American health authority FDA (US Food and Drug Administration) again and again. In this newsletter, we would like to present the three most important documents to you. Read more.


English Supervisory Authority MHRA Publishes Answers to FAQs on Risk Management

On its homepage, the English supervisory authority, MHRA, has published answers to frequently asked questions regarding the topic of quality risk management. Here you can read the answers.


The New GAMP Good Practice Guide: How to Operate Computerised Systems in a GMP-Compliant Way

Alongside validation, the (GMP-compliant) operation of computerised systems is also becoming an increasingly higher priority. A new GAMP Good Practice Guide gives comprehensive support on this matter. Read more here.


Specific Requirements on Plastic Packaging Materials for APIs and Solid Dosage Forms?

Which requirements do plastic packaging materials intended for packaging solid oral dosage forms and for packaging active pharmaceutical ingredients have to fulfil? The EMA's Q&A section provides important information.


Revision of EP chapter 5.1.6. Alternative Methods for Control of Microbiological Quality

European Pharmacopoiea: The Modern Microbiological Methods Working Party published a questionnaire to the revision of Chapter 5.1.6 “Alternative Methods for Control of Microbiological Quality Rapid Microbiological Methods. More details can be found here.


Part 2 EU GMP Guide on APIs Will No Longer Be Identical to ICH Q7

The European Commission published a revised Part 2 text on GMP for APIs which will enter into force by 31 July 2010. Click here to read more.


New Best Practice Guides for the Submission and Processing of Variations published

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human has updated the Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Find further information here.


Recent Statement by FDA on Process Validation - 3-Batch Validation Obsolete?

In a recent questions-and-answers paper, the question if, according to cGMP, the manufacture of 3 validation batches is required before a new active pharmaceutical ingredient or medicinal product can be marketed is answered by the FDA in the negative. The reasons for the no can be found here.


FDA Guidance on "Mechanical Calibration of Dissolution Apparatus" Passed

The final FDA Guidance for Industry on mechanical calibration of dissolution apparatus 1 and 2 was published in January 2010. Compared to the 2007 draft version, the guideline was completely revised; however, the conclusions and the recommended method for mechanical calibration remained unchanged. Read more here.


New CAPA Guidance Published

A concrete instruction for the implementation of the CAPA requirements cannot be found in the hitherto existing guidelines. Here, a newly proposed guidance by the GHTF can help. Read more here.


FDA Publishes Statement on the Frequency of Media Fills

In the document "Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs", the FDA publishes statements on topical subjects. Recently, the authority published a statement on the number of annual media fills in relation to the number of shifts and depending on the use of isolators. Find more here.


Riboflavin Test for Cleaning Validation - Standardisation regarding Information Sheet of VDMA

An information sheet by the VDMA (German Process Plant and Equipment Association) gives recommendations on the standardisation of the riboflavin test (test of cleanability). Read more here.


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