What should the dietary supplement manufacturing follow?

GMP or HACCP?? and why?

Thank you in advance

Hi aarrowzzz and welcome to the cove.

Dietary supplements have their own section in the US Code of Federal Regulations:

21 CFR PART 111--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS (http://www.access.gpo.gov/nara/cfr/waisidx_08/21cfr111_08.html)

I don't think a HACCP program is required yet, but your customers may expect one to be in place.

i think to decide where the best system for your company is up to the objective of your company.... both of system is usefull for make product save for customer... but for me.. i will choose HACCP, there is system consist of GMP too.. and if we want to get ISO 22000, HACCP more easier than GMP only to adapt the system of ISO 22000...

For us, it is regulated - GMP is minimum.

What should the dietary supplement manufacturing follow?

GMP or HACCP?? and why?

Thank you in advance

Hi arrowzzz,

It depends where you are marketing your dietary supplements. GMP is a requirement if your dietary supplement is sold in US as GMP is a FDA concept. Therefore, have GMP as a minimum for US and build upon HACCP.

But for rest of the world, you could have HACCP, ISO 22000 or other QMS like GMP also.

All the comments are true. well when implementing a Food Safety Management System (FSMS) e.g HACCP/ISO22000 you have to go through PRPs (prerequisite programs). PRPs are the minimum requirements that need to be in place for your FSMS to function well. PRPs include such programs as cleaning and sanitation and pest control and tend to be well covered in most GMP programs/requirements.

I strongly recommend that you implement HACCP. it works fine