Risk analysis

GOOD MANUFACTURING PRACTICE (cGMP) RISK ASSESSMENT
1

Good morning,

I am student of Gdansk University of Technology in Poland. I am currently writing my master thesis. Its subject is: ’ Risk analysis methods in complex technical plants oriented on functional safety assessmented’. And I need some examples of the risk analysis for process plants.

Thank you for help in advance

Regars,
Cezary Folejewski

2

sir,
Pls guide me for wrighting the sop for equipment validation.give me guidline or formate for preparation of sop for equipment validation.

thanks
anil saxena

3

[quote=anil saxena]sir,
Pls guide me for wrighting the sop for equipment validation.give me guidline or formate for preparation of sop for equipment validation.

thanks
anil saxena[/quote]

Dear Anil,
You will get free soft copy of equipment validation SOP on the site
www.validationonline.com
.

Regards,
Ameet M

4

Risk analysis is a technique to identify and assess factors that may jeopardize the success of a project or achieving a goal. This technique also helps to define preventive measures to reduce the probability of these factors from occurring and identify countermeasures to successfully deal with these constraints when they develop to avert possible negative effects on the competitiveness of the company.

5

Risk Analysis helps you identify and manage potential problems that could undermine key business initiatives or projects.
Risk is made up of two things: the probability of something going wrong, and the negative consequences that will happen if it does.
You carry out a Risk Analysis by first identifying the possible threats that you face, and by then estimating the likelihood that these threats will materialize.