ISO 13485:2003
FDA
cGMP
ISO 9001:2008
Good Manufacturing Practice or GMP
is part of a quality system covering the manufacture
and testing of active pharmaceutical ingredients,
diagnostics, foods, pharmaceutical products and medical
devices. The current GMP requirements set forth in the
Quality System (QS) regulation require that domestic or
foreign manufacturers have a quality system for the
design, manufacture, packaging, labeling, storage,
installation, and servicing of finished medical devices
intended for commercial distribution in the United
States. GMPs are guidelines that outline the portions
of production and testing that can impact the quality
of a product. GMP is a system for ensuring that
products are consistently produced and controlled in
accordance with quality standards. GMP covers all steps
of production; from the starting materials, premises
and equipment to the training and personal hygiene of
the staff. Detailed, written procedures for each
process that could affect the quality of the finished
product are necessary. There must be systems in place
to provide documented proof that accurate procedures
are consistently followed at each step in the
manufacturing process, each time a product is
made. .
ISO 13485:2003 ISO 13485:2003