GMP Risk Analysis RA 2x5

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

2012-05-08
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 ...

NEW: Checklist GMP Inspections available for Download now

for preparation and enforcement of audits

This ebook contains questions typically asked during inspections, arranged by subject-matter. The information sources include the

• 21 CFR 210/211/11 and the
• EU-GMP-Guide Parts I and II.

The Checklist GMP Inspections is great for both sides:

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