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Definition of raw and auxiliary packaging and semi-finished products in GMP standard

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the definition of raw and auxiliary materials in the supplementary provisions of Chapter 14 of GMP is: any material used in drug production except packaging materials

the good manufacturing practice for drugs (revised in 2010) (hereinafter referred to as the new version of GMP), which has been revised for five years and solicited public opinions twice, came into force on March 1, 2011

since its establishment on August 19, 1998, the State Drug Administration has attached great importance to the revision of GMP and held many symposiums to listen to the opinions of all parties, especially the opinions of drug manufacturers, the main body of GMP implementation

organize relevant experts to carry out revision work. The code for the quality control of drug production (revised in 1998) has been issued by the order of the director general of the State Drug Administration No. 9 and came into force on August 1, 1999

your question should be the definition of raw and auxiliary materials and semi-finished products? The definition of raw and auxiliary materials in the supplementary provisions of Chapter 14 of GMP is: any material used in drug production except packaging materials. In the “general cases” section of the Chinese Pharmacopoeia, the two terms are also explained in the “terms and terminology interpretation of biological products”: raw materials refer to all biological and chemical materials used in the production of biological products, excluding auxiliary materials. Auxiliary materials refer to the auxiliary materials used in the preparation of biological products, such as adjuvants, stabilizers, excipients, etc. Semi finished products refer to intermediate products that are uniformly prepared by diluting a batch of stock solution.

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