Brazil - Proposed Resolution defines the chapter "water for pharmaceutical purposes" of the Brazilian Pharmacopoeia.

Brazilian Health Regulatory Agency (Anvisa) has issued Resolution defines the chapter "water for pharmaceutical purposes" of the Brazilian Pharmacopoeia.

In this chapter it is considered water for pharmaceutical use the various types of water used in the synthesis of ingredients; in the formulation and production of medicines; in laboratories; diagnostics and other applications related to health, including its use as the main component in the cleaning processof utensils, equipments and systems.

Purification process, storage and distribution of water must comply with the pharmacopoeia specifications. The water quality requirements will depend on its purpose and use, as well as the purification system designed to meet the purity level established. The user is responsible for selecting the type of water appropriate to its objectives, as well as for the necessary controls to guarantee the maintenance of the desired quality.

This chapter also addresses the two major groups of water contaminants: chemical and microbiological contaminants.

There are three types of water for pharmaceutical use: purified water (AP); water for injections (API) and ultra-purified water (AUP), whose monographs are found in this Pharmacopoeia. Official international compendiums specify, in addition to these, other types of water, such as: packaged in bottles, sterile or bacteriostatic, for irrigation or inhalation. However, all have purity characteristics similar to the threefundamental types already mentioned.

In addition to these, there are potable water and reagent water, which are widely used and have direct application in pharmaceutical facilities, mainly in general cleaning procedures. Thus, the five types of water are considered, in relation to their main characteristics and application. Specific monographs, where available, detail purity parameters established for each type.

Proposed date of adoption: To be determined after the end of the consultation period

Proposed date of entry into force: To be determined after the end of the consultation period

Final date for comments: 29 March 2017

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.