GMP Clean Room and GMP Standards
GMP
Introduction
GMP
is the abbreviation of Good Manufacture Practice, is the reasonableness of the
production process, the applicability of the production equipment, accuracy and
normative of the production operations made mandatory requirements.
The latest edition of " Good Manufacturing Practice ( revised 2010 ) ‘’
was October 19, 2010 defined by the Health Ministry for consideration by hereby
release , since March 1, 2011 came into effect.
GMP is the
basic criteria for pharmaceutical production and quality management, is the key
processes affected product quality in production of pharmaceutical preparations
entire process and the manufacture of APIs. Vigorously promote drug GMP, in
order to avoid possible contamination of pharmaceutical production processes
and cross-contamination to reduce all kinds of errors occur, is an important
measure to improve the quality of medicines .
At present,
drugs produced in China sales in worldwide required manufacturers not only to
comply with the of China 's version of 2010 GMP norms, but also in line with
international EU / GMP standards, FDA-c GMP requirements.
GMP
did not list the biological clean room design, construction, testing and other
requirements. The details should refer to the relevant GMP implementation
guide, drug GMP certification examination assessment standards, FED209E,
ISO14644, ISO14698, IEST, international GB / T, EN1822 standards
Clean
room and contamination control technology is one of the main means to ensure
that GMP successful implementation.
Biological
Clean Room Standards
Air
Clean Class Level
Bio- clean room air clean area is divided into four areas:
Class A - high-risk operation area, which directly affects the operation area. Like sterilization tunnel oven, aseptic filling, bottle opening, autoclave cooling zones required 100 clean class laminar flow. Direct impact on the quality of products, called Class A.
Class B - indirect effects of the sterile operating area directly surrounding the class A area, like aseptic filling room, autoclave cooling room.
Class C and D - into the transition clean zone of the sterile production area. Preparation Room, changing rooms and a buffer room.
Bio- clean room air clean area is divided into four areas:
Class A - high-risk operation area, which directly affects the operation area. Like sterilization tunnel oven, aseptic filling, bottle opening, autoclave cooling zones required 100 clean class laminar flow. Direct impact on the quality of products, called Class A.
Class B - indirect effects of the sterile operating area directly surrounding the class A area, like aseptic filling room, autoclave cooling room.
Class C and D - into the transition clean zone of the sterile production area. Preparation Room, changing rooms and a buffer room.
GMP RSP Grading in Different Standards
Roughly Contrast
Prepared By: Vanessa Wang from Web: www.cleanroomffu.com
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