Validation of water systems used to produce demineralized, distilled, and water for injection is important in the pharmaceutical industry to ensure water quality. The document discusses the objectives, types, design, operation, and monitoring of water systems. Key aspects of validation include design qualification, installation qualification, operational qualification, and performance qualification to demonstrate systems consistently produce water meeting quality specifications under all operating conditions. Ongoing maintenance and revalidation if changes are made helps maintain system performance over time.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
In this slide contains details about Pharmaceutical validation of water system
Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
In this slide contains details about Pharmaceutical validation of water system
Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Water for Pharmaceutical Use........pptxNazim Hussain
Pharmaceutical water production, storage and distribution systems should be designed, installed, commissioned, qualified and maintained to ensure the reliable production of water of an appropriate quality.for pharmaceutical water systems.
Annex 1: Development of monographs for The International Pharmacopoeia Annex 2: WHO good manufacturing practices: water for pharmaceutical use Annex 3: Pharmaceutical development of multisource (generic) pharmaceutical products - point to consider
Annex 4: Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part.
Annex 5: Development of paediatric medicines: points to consider in formulation
Annex 6: Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredient.
Inspection of water systems
8.2 The following list identifies items and a logical sequence for a WPU system inspection or audit:
– a current drawing of the water system showing all equipment in the system from the inlet to the points of use along with sampling points and their designations;
– approved piping drawings (e.g. orthographic and/or isometric);
– a sampling and monitoring plan with a drawing of all sample points;
– training programme for sample collection and testing;
– the setting of monitoring alert and action levels;
– monitoring results and evaluation of trends;
– inspection of the last annual system review;
– review of any changes made to the system since the last audit and a check that the change control has been implemented;
– review of deviations recorded and their investigation;
– general inspection of system for status and condition;
– review of maintenance, failure and repair logs;
– checking calibration and standardization of critical instruments
Thornton recently published a helpful guide for best practices in pure water measurement. It is entitled "Compliance by Design in Pharmaceutical Water Systems". The document provides an summary of water sources and contaminants, then continues with an outline of industry requirements for bulk waters. The production of pure water is dicussed, and recommendations for pharmaceutical water system instrumentation are provided.
This guide is designed to provide a valuable and
convenient information resource to aid in the design of
pharma water systems that are compliant with the
requirements of global pharmacopeias. It offers vital
information on topics including requirements for
source bulk waters, control of biofilms, and the three
stages of water systems.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
3. Objective
General information on water systems
Design and engineering aspects of water systems
Inspection of water systems
The need for water quality manual
reason for usage of pharmaceutical water supply systems.
The technical requirements for water supply systems.
Different types of water supply systems.
Validation requirements.
Qualification & inspection requirement
3
4. Introduction
Water may be referred to as ‘the elixir of life’ – In the
pharmaceutical industry for which the quality of water is critical and
a high priority.
Water is an essential ingredient of various pharmaceutical
preparations and is also used to clean process equipment and hence,
plays a pivotal role in pharmaceutical processing's.
Water is the most widely used raw material in the manufacture of
Active Pharmaceutical Ingredients (API),in intermediates, in
finished dosage forms.
Water is thus an important raw material in GMP and in
validating the manufacturing process.
4
5. Continued…….
Why purification?
Although tap water is reasonably pure, it is always variable due to
seasonal variations, regional variation in quality.
One must remove impurities and control microbes to avoid
contamination of products.
Pretreatment depends on quality of feed water.
5
6. Continued…….
Quality of water should be specific for product quality.
Water contains,
Organic and inorganic impurities
Microbial contamination
Endotoxin
Particulate contamination
Low quality of water can lead to
product degradation
product contamination
loss of product and profit
6
7. TYPES OF WATER
Different grades of Water for Pharmaceutical Purposes-each type has
its on characteristic for all parameters.
Potable water
Purified water
Water for injection(WFI)
Sterile water for injection, inhalation, irrigation.
Bacteriostatic water for injections.
7
8. Potable water
Used in early stages of chemical synthesis.
Used early stages of equipment cleaning.
Sources: Public water supply, wells or combination of >1 of these
Must meet requirement of USEPA(40 CFR 141)
Seasonal variations of quality may occur and must be considered for
treatment before usages.
8
9. Purified water ( Demineralised, Distilled )
Used as excipients in manufacturing of Pharmaceuticals.
Used for equipment cleaning
Preparation of bulk chemicals.
Prepared using potable water as feed.
Types of Purification: Deionisation, Distillation, Ion exchange,
Reverse osmosis, filtration.
Must meet ionic, organic chemical and microbial requirements.
System that produce, store and circulate water under ambient
conditions are susceptible to bio films. This can be provided by
frequent sanitization and monitoring.
9
10. Water for injections
Used as excipient in manufacturing of potentials.
Used for equipment cleaning esp. product contact surfaces of sterile
products.
Preparation of sterile bulk chemicals.
Prepared using purified water as feed.
Method of preparation is multicolumn distillation.
Must meet ionic, organic chemical, microbial and endotoxins
requirements.
Factors like microbial contamination and endotoxins should be
controlled by circulation, frequent sanitization and monitoring.
10
11. DIFFERENT EQUIPMENTS AND COMPONENTS FOR
WATER SYSTEM
Piping
Valves
Pumps
Pressure gauges
Heat exchangers
Distillation unit
Filters
Deionizers
Sensors
Auxiliary equipment
11
12. VALIDATION CONCEPT
To prove the performance of processes or systems under all
conditions expected to be encountered during future operations.
To prove the performance, one must demonstrate (document) that
the processes or systems consistently produce the specified quantity
and quality of water when operated and maintained according to
specific written operating and maintenance procedures.
validation involves proving-
1. Engineering design
2. Operating procedures and acceptable ranges for control
parameters
3. Maintenance procedures to accomplish it
12
13. Continued…….
the system must be carefully,
-designed
-installed
-tested during processing, after construction, and under all operating
conditions.
Variations in daily, weekly and annual system usage patterns must
be validated.
13
14. WHY VALIDATION OF WATER SYSTEM?
To ensure reliable, consistent production of water of required quality
To operate system within design capacity
To prevent unacceptable microbial, chemical and physical
contamination during production, storage and distribution
To monitor system performance, storage and distribution systems
14
17. DESIGN QUALIFICATION (DQ)
DQ is documented the design of the system & will include :
Functional Specification.(Storage, purification, etc)
Technical/Performance specification for equipment.(requirements of
water volume and flow, define pumps and pipe sizes )
Detailed layout of the system.
Quality attribute of input water
Required plant output capacity
Selection of membrane
Designing of holding tanks pumps, heat exchangers and piping.
Design must be in compliance with GMPs and other regulatory
requirements.
17
18. Operational Qualification
The purpose of OQ is to establish, through documented testing, that all
critical components are capable of operating within established
limits and tolerances.
Operation Qualification Checks-
Identification of dead legs
Slope verification
Weld inspection
Pressure test
Passivation
The purpose of OQ is also to verify and document that the water
supply system provides acceptable operational control under “at-rest”
conditions.
18
19. Installation Qualification
IQ is in the form of checklist and it should include-
Water velocity test
Turbulence flow test (Reynolds number)
Quality attribute of output water
Prepare operational SOP
Prepare cleaning and sanitation SOP
Design action and alert limit
Collection and collation of supplier operating and working
instructions and maintenance requirements
19
20. Performance Qualification
The purpose of PQ is to verify and document that water supply system
provides acceptable control under ‘ Full Operational ‘ conditions.
Qualification phases
Phase I (investigational step): sampling and testing (4-6 weeks)
Phase II (verification step): sampling and testing (2-4 weeks)
Phase III (satisfactory completion step): sampling and testing
(Yearly activity, seasonal monitoring)
Establish action and alert limit
PQ should follow successful completion of IQ and OQ.
20
21. MONITORING
Monitoring and feed back data are important in maintaining the
performance systems. Monitoring parameters include:
Flow, pressure, temperature, conductivity, TOC
Samples taken:
From points of use, and specific sample points
In a similar way how water is used in service
Tests should include physical, chemical and microbial attributes
For example, stable state can be achieved by applying automatic
continuous monitoring of TOC and conductivity of the water system.
They are the major quality attributes of water by which organic and
inorganic impurities can be determined.
21
22. MAINTENANCE
Specified limits for purified water and water for injection
cfu* = colony forming units; ppb** = parts per billions;
EU*** = endotoxin units
Parameter Purified water Water for injection
Conductivity < 1.3 μs/cm at 25 °C < 1.3 μs/cm at 25 °C
pH 5.0-7.0 5.0-7.0
Bacteria < 100 cfu*/ml < 10 cfu/100ml
Total organic carbon < 500 ppb** < 500 ppb
Endotoxins N/A < 0.25 EU***/ml
22
23. CONTINUED…
A controlled, documented maintenance covering :
Defined frequency with plan and instructions
Calibration programme
SOPs for tasks
Control of approved spares
Record and review of problems and faults during maintenance
23
24. CONTINUED…
System sanitization and bioburden control
Systems in place to control proliferation of microbes
Techniques for sanitizing or sterilization
Consideration already during design stage – then validated
Special precautions if water not kept in the range of 70 to 80
degrees Celsius
24
25. REVALIDATION & CHANGE CONTROL
Once the validation is completed, the standard operating procedures
(SOPs) are formalized.
Routine operation should be performed according to the established
SOP.
If any deviation from SOP observed, determine the change and their
impact on whole system
Revalidation and evaluation should be performed depending upon
the impact of the change on system.
25
26. VALIDATION REPORT
Written at the conclusion of the equipment IQ, OQ and at
completion of process validation.
Will serve as primary documentation for FDA regulatory inspection
Will serve as reference document when changes to the system are
occurred and revalidation is needed.
26
27. VALIDATION DOCUMENTATION
Verification of design documentation, including
o Description of installation and functions
o Specification of the requirements
Instructions for performance control
Operating procedures
Maintenance instructions
Maintenance records
Training of personnel (program and records)
Environmental records
Inspection of plant
Finally certification (Sign Off) by Engineering, User (Production) and
QA Heads.
27
28. SUMMARY
Validation of water (demineralized, distilled and water for injection):
Play a major role in the quality of pharmaceuticals.
Must be designed properly by professionals.
Must be validated as a critical system.
28
29. SUGGESTED READING
Munson, T.E. “FDA View on Water System Validation.”
Proceedings of the Pharm. Tech. Conference 10-12 September 1985.
“FDA : Water for Pharmaceutical Purposes.” Inspection Technical
Guide 1986 No. 46. Rockville, Md., USA. Food and Drug
Administration, Public Health Services, Department of Health and
Human Services.
Rakesh Pahwa1*, Mona Piplani1, “Validation Aspects of Water
Treatment Systems for Pharmaceutical Products”, Tropical Journal
of Pharmaceutical Research, February 2010; 9 (1): 81-90
Vineet sharma, ”Design, Qualification, and Validation of Water
Systems”, Originally published in the November, 2004 issue of the
Journal of Validation Technology.
29