NHPD Stage 1: The Site Licensing System
By December
31, 2005, all manufactures, importers, packagers and labelers will employ good
manufacturing practices (GMPs) and have site licenses.
This
transition period allows two years for a person currently manufacturing,
packaging, labeling or importing a NHP to comply with the site license
requirements of the Regulations.
This system
requires that all manufacturers, packagers, labelers and importers be licensed
with respect to:
·
having documented procedures in place
respecting distribution records and product recalls;
·
having procedures in place for the handling,
storage and delivery of their products;
·
meeting good manufacturing practices (GMPs).
GMPs are to be employed to ensure product safety and quality.
The provisions required to meet these standards cover product
specifications, premises, equipment, personnel, sanitation programme,
operations, quality assurance, stability, records, product sterility, lot or
batch sample and recall reporting.
The
Regulations also set out circumstances for refusing, suspending or canceling a
site license.
