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The documentation connected with technological process is worked out in accordance with requirements of GMP. We have elaborated procedures of preparing, drawing, revising, confirmation and circulation of documentation, as well as introducing changes to it. The documentation connected with technological process is divided into documents on quality system and documents connected with production and control.
These are specifications, production formulas, technological instructions and instructions on packing, methodizes and production protocols of series and protocol of series packing. There are specifications worked out on exit raw materials, packing materials and ready products. Every pharmaceutical has production formulas and technological instructions.
Every pharmaceutical has confirmed instructions on packing. Technological process and all preparation processes are reflected in the protocol of series production. This allows observing the whole history of series production. |