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Introduction of the new version of GMP to prevent production process

Release Date: March 27, 2018

New GMP regulations on preventing pollution and cross-contamination during production

Article 197 During the production process, measures shall be taken as far as possible to prevent pollution and cross-contamination, such as:

(1) producing different varieties of medicines in separate areas;

(2) adopting staged production methods;

(3) Set up necessary air lock rooms and exhaust air; areas with different levels of air cleanliness should have differential pressure control;

(4) The risk of untreated or insufficiently treated air entering the production area again and causing pollution shall be reduced;

(5) In a production area prone to cross-contamination, operators should wear special protective clothing for that area;

(6) Equipment cleaning shall be carried out using verified or known effective cleaning and decontamination operating procedures; if necessary, the residue on the surface of the equipment in direct contact with the materials shall be tested;

(7) Production in a closed system;

(8) The air inlet of the drying equipment shall be provided with an air filter, and the exhaust air shall be provided with a device for preventing air from flowing backward;

(9) During the production and cleaning process, the use of fragile, desquamable, and moldy appliances should be avoided ; when using the screen, there should be measures to prevent pollution caused by the break of the screen;

(10) The preparation, filtration, potting and sterilization of liquid preparations shall be completed within the prescribed time;

(11) Storage periods and storage conditions shall be specified for semi-solid preparations such as ointments, creams, gels and suppositories.

Article 198 The measures to prevent pollution and cross-contamination shall be regularly checked and their applicability and effectiveness shall be evaluated.