WHO issues Update of Pharmaceutical Water Guideline - 31 Oct 2012
The WHO has updated it guideline on manufacture and distribution of water for pharmaceutical use as published in the current TRS 970 of the WHO, Annex 2. This revised guideline is a revision of WHO good manufacturing practices: water for pharmaceutical use, previously published in WHO Technical Report Series, No. 929, Annex 3, 2005. The objective of the guideline is to provide information on the quality of water to use for pharmaceutical manufacture and guidance on GMP regarding the design, installation and operation of pharmaceutical water systems.
The revision addressed the major comments received by the WHO Expert Committee during the latest circulation phase and adopted subject to inclusion. The key modifications adopted in the revised document include;
- Narrowing of the guideline’s scope by excluding the processing of small amounts of water utilised in pharmacies to compound individually prescribed medicines
- Emphasis on the importance of water system design in inhibiting microbiological growth in the system (previously sanitisation was the recommended approach)
- Placing the onus on the pharmaceutical manufacturer to ensure that the feed water supplying the purified water treatment system meets the attributes of drinking water, and where this isn’t the case appropriate measures must be in place prior to the treatment phase.
- Monitoring of drinking water has also been amended to consider seasonal effects in addition to environmental or supply changes which have an impact on the source water quality
Apart from these highlights the revised document is essentially the same as the previous version, with same layout and chapters.