 |
 
GMP
What is GMP?
Goods Manufacturing Practices (GMP) are issued by national and legal
authorities for health, such as the Food and Drug Administration (FDA)
in the USA and the European and national agencies in Europe. They
are also issued in relation to standardization policies and professional
codes.
Pharmaceutical Product Evaluation
In the health care products, field quality is critical. Equipment
(including facilities), utilities (pure gases, pure waters) and
process installations must be qualified and the associated processes
validated. Functional tests need to be performed to prove that equipment
and processes are designed, installed and maintained in a manner
that is appropriate for their required and predetermined use.
GMP benefits:
|
 |
Clean rooms and clean air devices qualification |
|
|
Sterilization systems |
|
|
Chambers with regulated temperature |
|
|
High purity water and gas systems |
|
|
Functional tests for temperature |
|
|
Product Assay and Hygienic Qualification |
|
|
Microbiological Test |
|
|
Chemical Assays & Heavy Metal Analysis |
|
