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Saturday, August 16, 2008

WATER SYSTEM VALIDATION MASTER PLAN SAMPLE DOCUMENT DOWNLOAD HERE

WATER SYSTEM VALIDATION MASTER PLAN FOR WHO GMP PHARMACEUTICAL MANUFACTURING COMPANY.

i am giving here a sample of this document you can use it for your self .

WATER SYSTEM VALIDATION MASTER PLAN FOR WHO GMP PHARMACEUTICAL MANUFACTURING COMPANY.

Your Company Name
Quality Assurance Department

WATER SYSTEM VALIDATION MASTER PLAN


Introduction :
The Site manufactures Injections , sterile powder for injection, creams, ointments, gels, Liquid orals ,Tablets and capsules and powders . The manufacturing of topical creams, gels and liquid orals is being done using demineralised water produced by DM water plant Model .
The Site has now replaced the demineralised water plant with the existing one
and concurrent validation of this DM Water Plant will be carried out as per the
Validation Protocol Ref. No. .1234

OBJECTIVE:
This DM Water Plant is installed with additional charcoal bed and
quartz filter , and reverse osmosis water purification system  and introduce a loop system and storage facility maintained at not less than 700 C to produce better quality of DM water .

APPROACH :
The basic function of an DM Water Plant is to produce better quality of water
which is anion & cation free and microbiologicaly free by passing it through
ultraviolet light.

Retrospective validation of DM Water Plant will be carried out with respect to
the DQ, IQ & OQ. Concurrent validation will be carried out as per the protocol
ref. no. .DMP/ xzy
Validation plan & protocols will be drawn by Executive , Quality Assurance in
consultation with the Production Manager.

For details refer " Organisation and Responsibilities "

SCOPE :
This is applicable to manufacturing of creams, ointments and liquid orals and tablets and cleaning of equipments.

JUSTIFICATION :
The validation exercise when performed and completed as per the validation plan shall conclusively demonstrate the adequacy / non adequacy of the equipment to produce better quality of water ( chemical and microbiological ) and effectivity of regeneration system.
Output of better quality of water will indicate the effectivity of the charcoal bed , the quartz filter, Cation and Anion bed , Mixed bed , UV and heat Treatment.




ACCEPTANCE CRITERIA :
As mentioned in the protocol ( Ref. No. .1234)


SUPPORT PROGRAMME :
SOP for operation of the DM Water Plant, must be in place. (SOP ref. no.----xyz)
• Training & evaluation of the operators and the records for the same.
• Annexures pertaining to each stage of validation activity.

ORGANISATION AND RESPONSIBILITIES :
NAME DESIGNATION RESPONSIBILITY


VALIDATION SUMMARY REPORT:

The Validation of DM Water Plant was carried out as per the Validation protocol ref. no. ./WP/2011. The observations were found to comply with the Acceptance criteria at every stage of validation .

Hence DM Water Plant can be used for futher operation.

VALIDATION REVIEW & REVALIDATION:

Review of the validated status of the DM Water Plant will be carried out at a frequency of once in a year. Revalidation will be performed in case of any modification made to the DM Water Plant which will affect the existing validated status of the DM Water Plant.


NEXT VALIDATION ON :

WATER SYSTEM VALIDATION MASTER PLAN SAMPLE DOCUMENT HERE

Pints should be covered during validation of water system

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1 comment:

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This website consist of detail Information about Pharma Guidelines Pharma Regulatory Affairs USFDA Guidelines WHO Guidelines Pharmaceutical Quality Management System Pharma Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test