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GMP Risk Analysis RA 2x5

No. 15/2012 - May 2012

Dear Colleagues,

the final rule on sterility testing for biologics is coming into operation in June (see the GMP News). Biological products are more and more in the focus of the regulators. But also the risk based approach is a hot topic in the field of GMP.

In our feature today - out of the practice - we givt you insight into a modification of the traditional FMEA approach which is appropriate to all machinery suppliers of the pharmaceutical industry. Imagine you would save 30% of your effort when performing a GMP risk analysis!

Thomas Peither



Risk Analysis RA 2x5

Learn in our today's feature how to perform a risk analysis of a technical system efficiently and GMP compliant. Save time and ressources by performing the RA2x5 approach.

Learn, why it makes sense not to rate the probability of detection when you deliver equipment and machinery. With the RA2x5 approach you concentrate on critical functions within the qualification procedure and increase the efficiency and GMP compliance with a modification of the FMEA.

One click and you can read the feature "GMP Risk Analysis2x5".


Over 4500 pages of GMP knowledge

GMP MANUAL: GMP-data presented in two sections:

GMP in Practice, written by noted industry specialists and according to international GMP Regulations. All articles are reviewed for accuracy and validity by an international Advisory Board and industry experts.

GMP Regulations, continuously updated, contain important GMP Regulations from Europe, USA, Japan, China, Canada, PIC/S, ICH and WHO.

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GMP News

FDA: Sterility Testing of Biologics - Final Rule

The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.
Read more ...


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