Please click here, if the newsletter is not displayed correctly.
 
Logfile /

GMP Risk Analysis RA 2x5

No. 15/2012 - May 2012
       
Contents

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!

Regards,
Thomas Peither

       

Image

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".

Image

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.

Paper or digital? - Take your pick

Paper and CD-ROM | CD-ROM only | Online Named User Licence | Online Corporate Licence |
Paper and Online Named User Licence
>>> More information: GMP MANUAL

GMP Subject Downloads, e.g. Risk Management:

Separate chapters of the "GMP in Practice" section of the GMP MANUAL are available for download!
>>> More information: GMP Subject Downloads

Image

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 ...

Image

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:

  • Get prepared for an approaching audit
  • For your own inspection and documentation

112 pages | PDF file | ISBN: 978-3-943267-26-6 | Excerpt from the GMP MANUAL

Price: € 199.00* / US$ 299.00*
*plus tax if applicable

>>>Order now: Checklist GMP Inspections - PDF Download

Image

You receive this newsletter because you have previously registered on www.gmp-publishing.com. If you want to unsubscribe from this service, please click here
This email was sent by logfile@gmp-verlag.de
Maas & Peither AG | GMP Publishing | Karlstrasse 2 | 79650 Schopfheim Germany
Phone +49(0)7622 666 86-70 | Fax +49(0)7622 666 86-77

Maas & Peither America, Inc. | GMP Publishing | 1060 First Avenue, Suite 400 | King of Prussia, PA 19406 USA
Phone +1 (610) 768-8028 | Fax +1 (610) 337-9548
 
Copyright © 2014 Maas & Peither AG