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Sunday, July 31, 2011

Pharma water system validation

Validation of water system in pharmaceutical:
Many time it happens that the purified water for pharmaceutical use is used up in the manufacturing of pharmaceutical product even before microbiology results are on, it is used after passing the chemical tests and microbiology tests are still waiting for results, as the final test results for microbiology tests requires at least 48 to 72 hours . This is one of the scenarios which is likely to be there, never the less the regulation are very stringent.
FDA and good manufacturing practice guidelines require that water must comply the both chemical and microbiology standards. Drug can be deemed adulterated if found the facility not in compliance with cgmp guidelines.

How to ensure that the water being used in the pharmaceutical manufacturing complies the test for microbiology. Validating water purification system assures that the water comply the test for microbiology as well. Validation of water system is a continuous process of establishing the evidence and assuring that the water produced as purified water complies with the predetermined standards of chemical and microbiological quality, which involves regular and extensive sampling and testing of source water as well as water produced and being handled in the water system. Validating the alert limit and action limit for tests results are most important tool in ensuring that the purified water produced comply with chemical and microbial limits. Conductivity and total organic content test are very important in assessing chemical and organic contamination level in water.

The most important part of validation of water system is validating the efficacy of water distribution system which involves distribution piping and storage, to the point storage vessels, which many times are found to be contributing to microbial growths.

Steps in validation of water system.
Validation of water system involves defining the water standards, qualification of the design for water purification system, qualification of installation as per required drawings and design, qualification operational standards .

Defining the predetermined quality of water, standards for final water and source water. This involves making a validation master plan. Define the standards required for water to produced in the system , for example is the water being used for sterile dosage form as water for injection then the limits and standards will be different than purified water, one can set their own requirements and standards as an internal quality assurance system.


Source of feed water
Feed water must comply to the quality of water with respect to 40 CFR 141 , or should comply EU guidelines or with the who guidelines for drinking water.Complying with these minimum limits for organic and inorganic impurities, heavy metal , trihalomethane, and microbial load, will ensure that the water pretreatment system will require to eliminate small amount of Source feed water must be free from coli form and pathogenic organisms .Even though source feed water meet the standards it may contain other microorganisms, and the organic and inorganic impurities which may be required to eliminate for its compliance as purified water for pharmaceutical use.

 Disigne qualification: An appropriate system design is selected based up on the requirements of water.
Which involves qualifying operations, operation controls, equipment and piping, and respective technology?

 Instalation Qualification: In this step the system is evaluated for compliance with installation with respect to its design its verification, inspection of drawings, calibration of monitoring systems.

 Operation Qualification: Testing the equipment if it is capable of producing required quality of water, if the monitoring system alerts properly, in this process the appropriate action and alert limits are set .

Performace Qualification: To establish that the all parameters and standards are meet , all alert and action limits perform properly . To establish pharma water system performs to its standards. Evaluating the effectiveness and efficacy of ongoing controls for example sanitization procedure.

Establishing system of continuous validation or validation life cycle, change control, calibration , corrective maintenance , preventive maintenance to ensure the validity/ validation, and revalidation criterias and time frame

Periodic review of the system, and qualification of the system.

Validation of sanitization procedures , the validation studies should establish that the sanitization process is efficient and effectively sanitize the water system , if the thermal method of sanitization is used then one should be able to demonstrate that the required temperature is attained at all points in the water system.
If chemical agents are used for sanitization then it is required that the chemical agent reach at all point and remain for sufficient time and in contact at all points.

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You will get all pharma regulatory affairs pharmaceutical  validation guidelines, pharma process validation, cleaning validation, clinical trail regulatory pharma guideline. here on whoguideline.blogspot.com, which has turned in to the worlds most popular pharma guidelines blog.
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