WHO good manufacturing practices: water for pharmaceutical use – Free PDF download

TRADELABOR has more than 20 years of experience in the control and treatment of air, working with an experienced and qualified technical staff and with the most advanced technology in this area, which together guarantee the quality of the services provided.

 

 

Pharmaceutical water production, storage and distribution systems should be
designed, installed, commissioned, quali”ed and maintained to ensure the reliable
production of water of an appropriate quality. It is necessary to validate the water
production process to ensure the water generated, stored and distributed is not
beyond the designed capacity and meets its speci”cations.

The capacity of the system should be designed to meet the average and the
peak $ow demand of the current operation. If necessary, depending on planned
future demands, the system should be designed to permit increases in the capacity or designed to permit modi”cation. All systems, regardless of their size and
capacity, should have appropriate recirculation and turnover to assure the system
is well controlled chemically and microbiologically.

The use of the systems following initial validation (installation quali”cation
(IQ), operational quali”cation (OQ) and performance quali”cation (PQ)) and a%er
any planned and unplanned maintenance or modi”cation work should be approved
by the quality assurance (QA) department using change control documentation.

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Download PDF file

 

Continue at:  https://www.who.int/medicines/areas/quality_safety/quality_assurance/GMPWatePharmaceuticalUseTRS970Annex2.pdf?ua=1

 

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