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Water is one of the most widely used substances, and raw material, or an ingredient in the production, processing, and formulation of pharmaceuticals. Control of the organic and inorganic impurities and microbiological quality of water is important because proliferation of micro-organisms ubiquitous in water may occur during the purification, storage, and distribution of this substance.

Although there are various quality grades of water used for pharmaceutical purposes, all kinds of water are usually manufactured from drinking water or comparable grade water as a source water.

Grades of water are closely related to the manufacturing methods and distribution systems of water. Major differences among these grades of water consist of the following quality attributes:

  • Microbial counts
  • Endotoxin, which is due to the presence of microbes
  • Organic and Inorganic impurities

Grades of water specified in the compendia (USP) are classified according to the quality attributes as:

  • Portable water
  • Purified water
  • Water for injection
  • Sterile water for injection
  • Sterile water for inhalation
  • Sterile water for irrigation
  • Sterile bacteriostatic water for injection

Selection of Water for Pharmaceutical Purposes

The quality attributes of water for a particular application are dictated by the requirement of its usage. Sequential steps that are used for treating water for different pharmaceutical purposes include:

  • Softening
  • Dechlorination
  • Deionization
  • Reverse Osmosis
  • Ultrafiltration
  • Distillation

The manufacturing method and distribution system also have a close relationship with the construction design of facilities and equipment. The most important items to consider are:

  • Selection of the most suitable quality grade of water for its intended use.
  • Determination of the water manufacturing system elements, including facility and equipment.
  • Design of water manufacturing system, including the design of system equipment.
  • After construction of the water system is completed based on its design, the system has to be scrutinized as to whether it has been built to design specification or not.
  • After confirming the installation of facility and equipment, the quality of water produced is examined from various viewpoints according to the predetermined specifications.
  • In the routine production of water, representative quality items of water have to be monitored to confirm the performance of normal operation, and if any undesirable trends or out of specification values are found, corrective action should be taken.
  • The steps of checking design and construction, confirming proper installation and operation, and documenting these processes are collectively called qualification or validation.

Major items of quality attributes that should be controlled and specified for pharmaceutical use are:

  • Organic Impurities
  • Inorganic Impurities
  • Particulates
  • Microbes
  • Endotoxins

Design Qualification of Water Systems

The quality attributes of water for a particular application are dictated by the requirements of its usage. Production of pharmaceutical water employs a combination of sequential unit operations that address specific water quality attributes.

The validation plan should be designed to establish the suitability of the system and provide a thorough understanding of the purification mechanism, range of operating conditions, required pre-treatment, and the most likely mode of failure. It is also necessary to demonstrate the effectiveness of the monitoring scheme and to establish the requirements for validation maintenance.

The selection of specific unit operations and design characteristics for a water system should take into consideration the quality of the feed water, the technology chosen for subsequent processing steps, the extent and complexity of the water distribution system, and the appropriate requirements.

In a system for WFI, the final process must have effective bacterial endotoxin reduction capability and must be validated for each specific bacterial endotoxin reduction capability and must be validated for each specific equipment unit. The final unit operations used to produce WFI have been limited to distillation, reverse osmosis and/or ultafiltration. Distillation has a long history of reliable performance for the production of WFI.

Other technologies, such as reverse osmosis and ultrafiltration, may be suitable in the production of WFI if they are appropriately validated for each specific set of equipment.

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  • Kuldeep Yagik

    Dear,
    Allthough its good Article but I want to discuss that “Is it required to validate or monitor Water Treatment system also with generation system & distribution system.” So please let me know.

  • Kuldeep Yagik

    Dear,
    Allthough its good Article but I want to discuss that “Is it required to validate or monitor Water Treatment system also with generation system & distribution system.” So please let me know.

  • Dr.RDPATRO

    please send the validation of WFI,Fermentors and dry heat sterilizers

  • Dr.RDPATRO

    please send the validation of WFI,Fermentors and dry heat sterilizers

  • vpandya2006@yahoo.co.in

    i want to valiadtion guild line for Havc system

  • vpandya2006@yahoo.co.in

    i want to valiadtion guild line for Havc system

  • Dr.RDPATRO

    u have cleared many doubts on validation of WFI

  • Dr.RDPATRO

    u have cleared many doubts on validation of WFI

  • Dr.RDPATRO

    excellent information was provided

  • Dr.RDPATRO

    excellent information was provided

  • lalit garg

    i want validation of wfi

  • lalit garg

    i want validation of wfi

  • http://wwwyahoo.co.in dharmender singh UP Balrampur

    i want validation of wfi but it is very critical vew

  • http://wwwyahoo.co.in dharmender singh UP Balrampur

    i want validation of wfi but it is very critical vew

  • kawther

    please can i have a draft copy for performance qualification protocol and also report what shuld i test

  • kawther

    please can i have a draft copy for performance qualification protocol and also report what shuld i test

  • punam

    plz send me guideline for validation of water system and guide me about that which parameter should be checked during water system validation….

  • punam

    plz send me guideline for validation of water system and guide me about that which parameter should be checked during water system validation….

  • lale jahani

    please send me WFI & RO validation with details that indicated which parameters are necessary to point.

  • lale jahani

    please send me WFI & RO validation with details that indicated which parameters are necessary to point.

  • http://www.gmail.com sanjeev kumar

    Dear sir,
    i am sanjeev doing job in indswift labs like as microbiologist.
    dear sir i want some notes about water validation and dry heat sterilizers
    plz sir send me.

  • http://www.gmail.com sanjeev kumar

    Dear sir,
    i am sanjeev doing job in indswift labs like as microbiologist.
    dear sir i want some notes about water validation and dry heat sterilizers
    plz sir send me.

  • Satish Bhatt

    plz suggest me about the step where PH adjustment in water treatment plant done & why

  • Satish Bhatt

    plz suggest me about the step where PH adjustment in water treatment plant done & why

  • VIPPAN RANA

    I WANT COMPLETE IMFORMATION OF WATER VALIDATION SYSTEM

  • VIPPAN RANA

    I WANT COMPLETE IMFORMATION OF WATER VALIDATION SYSTEM

  • Nan

    plz send me guideline for validation of water system and guide me about that which parameter should be checked during water system validation and draft copy for performance qualification protocol and also report what shuld i test

  • Nan

    plz send me guideline for validation of water system and guide me about that which parameter should be checked during water system validation and draft copy for performance qualification protocol and also report what shuld i test

  • http://www.gmail.com shivnarayan

    Your Comment how many phase perform in water validation &why

  • http://www.gmail.com shivnarayan

    Your Comment how many phase perform in water validation &why

  • shivnarayan

    Your Comment plz send the latest cleaninig validation guideline .

  • shivnarayan

    Your Comment plz send the latest cleaninig validation guideline .

  • Santosh Oza

    Sir,

    Can u provide guide line (Protocol) for water system validation.

  • http://www.samacm.com fadi khattab

    what is the reference of time period for performance qualification (phase 1, phase 2, phase 3) is that any guide line for this time as WHO , USB , EP ………ast

  • manikandan

    i need water for injection validation procedures kindly explain to all process parameters in usp method

  • UPPANAPALLI NAGESWARA RAO

    Sir

    Please send the complete water validation process for pharmaceutical preparation for formulations and method of testing.

  • http://www.yahoo.com UPPANAPALLI NAGESWARA RAO

    Sir

    Please send the complete validation process of Water for pharmaceutical formulations and testing method.

    Thanking you Sir

    U.Nageswara Rao

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Not all suppliers are the same, for example when you buy a car or a house, time and effort is dedicated into finding the best provider with the best product in terms of quality and reliability.

Choosing a Vendor

The same methodology needs to be dedicated when choosing a vendor for your business. Not only will you be purchasing their products or services, but you will also be dealing with them on a regular basis hence your personal relationship most also be strong.

Regulated Environment

When working in a regulated environment one of the key questions that needs to be considered is will the product of service affect your product quality. If the answer is yes then it is paramount that you can trust your supplier/vendor and the quality of their product or service

Supplier Qualification Online Course

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About Us

Learnaboutgmp is a cloud based learning management system (LMS) designed specifically for life science and regulatory organizations. Our LMS contains the courses you need to help you achieve regulatory compliance. With new courses published every month and existing courses updated in line with regulatory changes we are your true continuous learning platform.

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Choosing the correct software for your organisation is a tricky task and even more so when you are working in a regulated environment.

It’s one thing finding a great software package but if the vendor does not take their quality system seriously this could have a dramatic effect on the evolution and robustness of the solution.

They need to take their quality efforts as seriously as you take yours otherwise product quality and patient safety could be compromised.

An overall quality audit should be performed on each vendor before a decision is made, below are a list of questions that you could ask each vendor specifically on their quality system.

If the software vendor does not take their Quality System seriously you need to walk away.

Quality System Questionnaire

  1. Does the company have an established and Documented Quality System?
  2. Does the Quality System adequately reflect the client’s quality engineering policies?
  3. Is the responsibility for Quality defined (SOP)? What are their qualifications?
  4. Is Quality System documentation adequately controlled in terms of review, approvals and distribution
  5. Is the QS documentation regularly updated and otherwise maintained appropriately? (frequency)
  6. Are there procedures for reviewing the performance of the QS e.g. Internal Audit, Management Review?
  7. Are there training procedures and Job specifications? Are these adequate for the Maintenance of the QS
  8. Is there a Quality Plan for the Design, Development and Implementation of the products?
  9. Do the company use Sub Contractor’s?
  10. Do the company have control over any Sub Contractor’s QS? e.g. Vendor Assessment, Specification, Documentation review and approval?
  11. Do the company have access to relevant Sub-contractor Quality documentation?
  12. Is Sub Contractor’s Quality System compatible with the previous questions of this section?
  13. Have the Sub Contractors been audited? Review the report?
  14. Has accreditation/registration been achieved for: BS 5750 Pt. 1 or 2, TickIT, ISO 9000, Other (name
  15. Does the company operate to GAMP for computer systems?
  16. Are there SOPs for QC? Is there a release procedure?
  17. Is there an out-of-specification procedure?

Choosing the correct software application for your organization is a very tricky task and one that takes alot of upfront planning in order to make the correct choice.

The task has even got more difficult with the emergence of cloud based technology and how that impacts the overall validation process.

Remember to outline your requirements clearly and get buy-in from the other business owners.

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