GB 28670-2012 (English Version) General rule of pharmaceutical machinery conforming to good manufacturing practice

Standard No.: GB 28670-2012
Language: Chinese, Available in English version
Release Date: 2012
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB 28670-2012

Scope: This standard specifies the general requirements for pharmaceutical machinery (equipment) to implement the Good Manufacturing Practice for Pharmaceuticals. It is also the basic requirement for the quality control and management of pharmaceutical machinery (equipment) products. This standard applies to product design, manufacture, inspection, installation, operation, maintenance and verification of pharmaceutical machinery (equipment).

GB 28670-2012 Referenced Document

GB 12158-2006 General guideline for preventing electrostatic accidents
GB 150.1-2011 Pressure vessels.Part 1:General requirements
GB 151-1999 Tubular heat exchangers
GB 17914-1999 Specifications for stoage and preservation of combustible and explosive goods
GB 17916-1999 Specifications for stoage and preservation of toxicant goods
GB 3836.1-2010 Explosive atmospheres.Part 1:Equipment.General requirements
GB 50231-2009 General code for construction and acceptance of mechanical equipment installation engineering
GB 5226.1 Safety of machinery--Electrical equipment of machines--Part 1: General requirements*， 2019-06-04 Update
GB 5959.6-2008 Safety in electroheat installations.Part 6:Specifications for safety in industrial microwave heating equipment
GB/T 15692-2008 Terms of pharmaceutical machinery
GB/T 28671-2012 Guidelines for pharmaceutical machinery validation
GB/T 4272-2008 General principles for thermal insulation technique of equipment and pipes
GB/T 9969 General principles for preparation of instructions for use of industrial products
HG 20660-2000 Classification of Toxicity Hazards and Explosion Hazards of Chemical Mediums in Pressure Vessels
TSG D0001-2009 Pressure pipe safety technology supervision regulation for industrial pressure pipe
TSG R0004-2009 Supervision Regulation on Safety Technology for Stationary Pressure Vessel

2012 GB 28670-2012 General rule of pharmaceutical machinery conforming to good manufacturing practice