{ENGLISH} CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – PART 2

CHAPTER 5 WATER FOR THE MANUFACTURE OF PHARMACEUTICALS – PART 2

5. Overseas standards for pharmaceutical water

The types and uses of pharmaceutical water have been described based on the JP (Japanese Pharmacopoeia), but this is a domestic standard, not a universal standard.

The US Pharmacopeia (USP) and the European Pharmacopoeia (EP) are the standards for pharmaceutical water in the U.S. and Europe, respectively.

The EP is issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM) within the Council of Europe. Medicines and HealthCare (EDQM), which is part of the Council of Europe.

6. Different standards in the three regions

Table 4 shows the types of pharmaceutical water in USP and EP corresponding to those in JP, whereas JP specifies “Water” as raw water to produce “Purified water” and “Water for injection”.

In contrast, USP and EP do not have a standard for “Drinking water” and define it as drinking water or potable water.

Tables 5 and 6 compare the water quality specified in the respective pharmacopoeias for bulk water used in the manufacturing process of pharmaceutical products.

In order to keep the impurity content below a certain level, each pharmacopoeia specifies a conductivity and TOC value, while the EP requires that some impurities be chemically analysed and kept below a certain level.

Regarding specific values, each of the pharmacopoeias specifies a TOC value of 0.5 mg/L or less, but the values for conductivity differ slightly.

As for microbiological control, each Pharmacopoeia sets the standard values of the number

of viable bacteria in purified water (PW) at 100 cfu/mL or less and…