| Subject |
Title |
Date
Released |
Synopsis |
|
Quality
Systems:
Setup |
NHP Quality
Systems:
Setup
Click to view»
|
March 2010 |
• |
Provides an overview of the quality system setup requirements to bring a viable NHP to market |
|
| Overview |
Natural
Health Product
Regulations
Click to view»
|
March 2009 |
• |
Provides an overview of NHPs and what is new with NHP
regulations |
| |
|
|
Product
Licensing |
NHP Product
Licensing
Click to view»
|
March 2009 |
• |
Details the Product Licensing Application process and
post-licensing requirements for all types of PLAs |
|
| Site
Licensing |
NHP Site
Licensings
Click to view» |
March 2009 |
• |
Details the Site Licence
Application process |
| • |
Provides information on
Quality Assurance Reports
and the Site Licence Renewal
cycle |
|
| Good
Manufacturing
Practices |
NHP Good
Manufacturing
Practices
Click to view» |
Feb 2009 |
• |
Provides an overview of GMPs
for NHPs. |
| • |
Provides information on the
GMP requirements for places,
people, processes, and
products as they pertain to
NHPs |
|
| FDA Dietary
Supplement |
FDA Dietary
Supplement
Click to view» |
Feb 2009 |
• |
Details the FDA final rule
regarding cGMPs for dietary
supplements, including
requirements for
manufacturing, packaging,
and labeling and the
compliance date schedule |
