The document discusses the stages of equipment qualification which include design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It states that DQ establishes functional and operational specifications and should be done by the user. While the vendor performs IQ for large, complex instruments, the user performs it for small, low-cost ones. OQ and PQ can be done by either the vendor or user, but PQ should always be done by the user since the applications are specific. The document provides details on the contents and objectives of each qualification stage.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
This presentation was made to solely for students to make them aware/ understand basics of “Instrument Qualification/Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from various books and websites
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs)
used as starting materials in the production of these products is subject to strict good
manufacturing practice regulations that are designed to ensure their quality, safety and
efficacy. This ensures that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
The cGMP regulations for final medicinal products are clearly defined in each country
and region. The content of the regulations may vary but the objectives are the same:
- To deliver high quality, safe medicines manufactured and distributed following
controlled procedures to treat diseases and
- To prevent deaths, serious illnesses, adverse events or product recalls resulting from
deficiencies in the manufacturing and distribution processes.
While in the vast majority of cases, the pharmaceutical industry, under the oversight of
the Regulatory Authorities and inspectorates consistently applies appropriate cGMP
practices,
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
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
This presentation was made to solely for students to make them aware/ understand basics of “Instrument Qualification/Validation”. These slides are part of lectures delivered in M. Pharmacy Curriculum & taken up from various books and websites
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs)
used as starting materials in the production of these products is subject to strict good
manufacturing practice regulations that are designed to ensure their quality, safety and
efficacy. This ensures that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
The cGMP regulations for final medicinal products are clearly defined in each country
and region. The content of the regulations may vary but the objectives are the same:
- To deliver high quality, safe medicines manufactured and distributed following
controlled procedures to treat diseases and
- To prevent deaths, serious illnesses, adverse events or product recalls resulting from
deficiencies in the manufacturing and distribution processes.
While in the vast majority of cases, the pharmaceutical industry, under the oversight of
the Regulatory Authorities and inspectorates consistently applies appropriate cGMP
practices,
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
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
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4. The vendor or the user
q The user has the ultimate
responsibility for the accuracy of the
analysis results and for equipment
qualification.
q DQ should always be done by the
user.
qWhile IQ for a
§ small & low cost instrument is
usually done by the user,
§ large, complex and high cost
instruments should be done by the
vendor.
Who should do Equipment
Validation?
5. qOQ can be done by either the user or
the vendor.
qPQ should always be done by the user
because its application is very specific,
and the vendor may not be familiar
with these. As PQ should be done on a
daily basis, this practically limits this
task to the user.
Who should do Equipment
Validation?
6. Design qualification (DQ)
qDesign qualification (DQ) defines the
functional and operational
specifications of the instrument and
details for the conscious decisions in
the selection of the supplier".
qList of steps that should be considered
for inclusion in a DQ:
ØDescription of the analysis
problem
ØDescription of the intended use of
the equipment
ØDescription of the intended
environment
7. Design qualification (DQ)
ØPreliminary selection of the
functional and performance
specifications
ØPreliminary selection of the
supplier
ØInstrument tests (if the technique is
new)
ØFinal selection of the equipment
ØFinal selection of the supplier and
equipment
8. • “IQ establishes that the instrument is
received as designed & specified, that it is
properly installed in the selected
environment, and this environment is
suitable for the operation & use of the
instrument.”
• Systems and equipment should be
correctly installed in accordance with an
installation plan and installation
qualification protocol.Requirements for
calibration, maintenance and cleaning
should be drawn up during installation.
• Installation qualification should include
identification and verification of all system
elements & parts.
Installation Qualification (IQ)
9. The qualification involves the
coordinated efforts of :
Two functions are remaining after
completion of installation
qualification:
qCalibration
qInstrument Data Sheet Preparation
The
vendor
The
Operating
Department
The Project
Team
QA
Department
Installation Qualification (IQ)
10. Operational Qualification (OQ)
Ø"OQ is the process of demonstrating
that an instrument will function
according to its operational
specification in the selected
environment."
ØThe proper operation of equipment is
verified by performing the test
functions specified in the protocol.
ØTraining of operators for the systems
and equipment should be provided &
training records maintained.
11. Operational Qualification (OQ)
ØSystems & equipment should be
released for routine use after
completion of OQ, provided that all
calibration, cleaning, maintenance,
training & related tests & results were
found to be acceptable.
12. Operational Qualification (OQ)
Following are the contents of equipment
operation qualification
1. Application S.O.P’s
2.Utilization List
3.Process Description
4.Test Instrument Utilized To Conduct Test
5.Test Instrument Calibration
6.Critical Parameters
7.Test Function (List)
8.Test Function Summaries
13. q"PQ is the process of demonstrating
that an instrument consistently
performs according to a specification
appropriate for its routine use ".
qPQ should always be performed under
conditions that are similar to routine
sample analysis
Performance Qualification
14. qThe Validation process is regulated by
the guidelines & restrictions set forth
by the FDA.
qValidation rules are given in the 21
CFR Part 210 & Part 211 as the part of
cGMP. (CFR: Code of Federal
Regulation created by US Government
that sets guidelines pertaining for food
and drugs)
Role of FDA in Validation
15. Questions
1. Which are the installation and
operation qualifications for the
validation of dissolution apparatus?
2. Give in brief about equipment
qualification (EQ).
3. What is EQ? Give the steps of EQ.
16. References
1. P. P. Sharma, “Validation in Pharmaceutical
Industry-concepts, approaches & guidelines”,
1st edition, 2007 Vandana Publication House.
2. B. T. Loftus & R. A. Nash, "Pharmaceutical
Process Validation", Drugs and Pharm Sci.
Series, Vol. 129, 3rd Ed., Marcel Dekker Inc.,
N.Y.
3. Berry I.R., and Nash R.A.,
”Pharmaceutical Process validation”
second edition, revised and expanded;
Marcel Dekker series; 83-110.
4. WHO TRS No.937,2006,pg no.:143-173
5. Agalloco J.A, Carleton F.A, ”Validation of
Pharmaceutical Process, Third Edition,
175,223.
