3 replies to this topic

[ChrisN]

Hello people,

 

Does anybody have experience with making a Haccp for pharmaceutical products?

 

Kind Regards,

Chris 

[mesophile]

Hi Chris,

 

It shouldn't matter what products you are making a HACCP for providing you follow the 12 steps thoroughly. HACCP is all about food safety therefore your first few steps are vital here to determine the latter principles.

 

Have you got a team that can be brought together to design the HACCP and discuss each of the steps? These should be as varied and knowledgeable as possible. You will need to be a strong leader here to stop the team from going off in tangents and missing the big pictures. 

 

Good luck,

 

Simon

[skredsfan]

Hello people,

 

Does anybody have experience with making a Haccp for pharmaceutical products?

 

Kind Regards,

Chris 

 

I've been waiting for this question to arise!! I work in the paperboard packaging industry, and recently led our company through implementation of our food safety programs, as well as certification to a GFSI Standard (FSSC 22000). We manufacture food, beverage, as well as other consumer packaging, including pharmaceutical! I often wondered why similar standards/equivalents didn't exist for the pharmaceutical industry, since the FDA regulations are so stringent? I learned recently that an ISO Standard exists for pharmaceutical packaging, and is relatively new! Here's to round 2!!

[Charles.C]

Hello people,

 

Does anybody have experience with making a Haccp for pharmaceutical products?

 

Kind Regards,

Chris 

Dear Chris,

 

"Pharmaceutical" is a rather wide scope.

 

It may/may not be a totally different ballgame to food depending on the specifics.

 

From a quick look at some internet texts, traditional HACCP is obviously in use in some cases. But everywhere, no idea.

 

More info might help -

 

Product / specification ?

Process details, eg Rigorously sterile environment ?.

I anticipate that Legislatory requirements will exist ? Presumably as per Netherlands ?

 

Rgds / Charles.C

 

PS - added - just as an example of Primary haccp features, PRPs, CCP tree etc, here is a reasonably detailed haccp system for manufacture of ethanol by a pharmaceutically oriented company. One omission as compared to some typical food processes is a limited formal discussion of risk assessment, partly due to the nature of the product maybe.

 

 haccp plan, ethanol.pdf   247.4KB   29 downloads