SOP on Usage of purified water for batch manufacturing and cleaning purpose

April 5, 2016September 11, 2024 Pharmaceutical Guidanace

SOP on Usage of purified water for batch manufacturing and cleaning purpose

Objective: To lay down a procedure for usage of purified water for batch manufacturing and cleaning purpose.

Scope: This Standard Operating Procedure is applicable for formulation plant of Pharmaceutical company name with location.

Responsibility

Operator shall be responsible for usage of purified water as per this SOP.

Production Supervisor / officer shall be responsible for implementation of the procedure as per this SOP.

Head Production / designee shall be responsible for compliance of procedure as per this SOP.

Abbreviations and Definitions

SOP – Standard Operating Procedure

QA – Quality Assurance

Procedure

Remove the shrink wrap from the nozzle.

Open the valve of the nozzle.

Drain the purified water for minimum 2 minutes.

Close the valve.

Connect the Hose/pipe to the nozzle.

Open the valve and take the required quantity of purified water.

After usage remove the hose/pipe from the nozzle and clean the hose pipe as per SOP.

Shrink wrap the nozzle after usage.

Forms and Records

Not Applicable

Distribution

Master Copy- Documentation Cell (QA)

Controlled Copies- Production and Quality Assurance

History

Date	Revision Number	Reason for revision
–	00	New SOP

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