The document discusses validation which is a process used to prove that manufacturing processes will consistently produce products meeting quality standards. It defines validation, describes related terms like qualification, and explains the various phases of qualification including design qualification, installation qualification, operational qualification, performance qualification, and requalification. The goals and key considerations of each qualification phase are outlined to establish that equipment is properly designed, installed, operated, and performs as intended.
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
DATION OF EQUIPMENT ICH AND WHO GUIDELINES FOR CALIBRATION AND VALIDATION OF ...deepalisanap31
Introduction to equipment
Calibration
ICH guidelines for calibration of equipment
WHO guidelines for calibration of equipment
Example for calibration of UV
Validation
ICH guidelines for validation of equipment
WHO guidelines for validation of equipment
Example for validation of tablet compression machine
Process Automation in Pharmaceutical Industry.pptxShalakaDhikale
With automation in place, pharmacies can now spend less on hiring and training employees while also reducing workplace manual errors. Automated systems operate with a better level of regulation and efficacy than people, whether it be when labeling, distributing medication, or performing any other daily task. Automation is the employment of tools and machinery in lieu of people to carry out physical and mental tasks during the production process.
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
RAW MATERIALS
It is basically the chemical ingredients of a process. starting material, in production of final product.
FINISHED PRODUCTS
Marketable product, transportable pack, salable pack
PACKAGING MATERIAL
Providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life.
IPQC
Providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form.
CPCSEA GUIDELINES
Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions (IAEC)
CPCSEA Nominee -important link between CPCSEA and IAEC
IAEC scrutinize all project proposals for experimentation on animals.
The validity of IAEC is for 3 years.
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...
Process Automation in Pharmaceutical Industry.pptxShalakaDhikale
With automation in place, pharmacies can now spend less on hiring and training employees while also reducing workplace manual errors. Automated systems operate with a better level of regulation and efficacy than people, whether it be when labeling, distributing medication, or performing any other daily task. Automation is the employment of tools and machinery in lieu of people to carry out physical and mental tasks during the production process.
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
RAW MATERIALS
It is basically the chemical ingredients of a process. starting material, in production of final product.
FINISHED PRODUCTS
Marketable product, transportable pack, salable pack
PACKAGING MATERIAL
Providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life.
IPQC
Providing accurate, specific and definite description of the procedures to be employed from the receipt of raw materials to the release of the finished dosage form.
CPCSEA GUIDELINES
Role of CPCSEA is to monitor animal experiments through ethics committees set up in institutions (IAEC)
CPCSEA Nominee -important link between CPCSEA and IAEC
IAEC scrutinize all project proposals for experimentation on animals.
The validity of IAEC is for 3 years.
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...
Pharmaceutical Validation, its scope and types. Validation Team. validation Master plan. Validation protocols. Elements of Validation. Approaches of Validation. Dosage form Validation along with example of Validation of Tablet Dosage form.
In this slide contains Calibration vs Qualification and phases of qualification.
Presented by: A.Siddartha Tharun Teja. (Department of industrial pharmacy).
RIPER, anantapur.
UL Webinar - Updates to the Regulatory Framework in Korea and their impact to...ulmedical
fIn this presentation UL technical expert, MinYong Choi, formerly with the Korea FDA provides a comprehensive overview of the Regulatory framework for medical and IVD devices in Korea. The presentation includes useful links, and insight into recent and planned changes to the regulations that may affect submissions for market approval.
Pilot Plant Scale Up Techniques Used in Pharmaceutical Manufacturing, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
Pharmaceutical Validation: Role in Phamaceutical Industrykaunainfathema1
This is a brief presentation on various concepts under Pharamaceutical Validation including its importance, scope, history, authorities, types of validation, VMP; along with the ICH and WHO Guidelines to be followed for Calibration of Equipments.
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.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
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
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
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.
2024.06.01 Introducing a competency framework for languag learning materials ...
Eqiupment validation
1. Prepared by
Shivam Thakore
Ankit Patel
Harsh Oja
Guided by
Mr. Nihar Shah
Associate professor
LJIP, Ahmedabd
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 1
2. What is Validation?
According to FDA, validation is method to
establish documented evidence which provides a
high degree of assurance that specific process
will consistently produce a product meeting its
predetermined specification and quality
attributes.
It is a quantitative approach needed to prove
quality, functionality and performance of
pharmaceutical manufacturing process. It is
very broad term.
It will apply to individual parts of
pharmaceutical equipment and also to the
pharmaceutical process as a whole.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 2
3. According to WHO, Validation is the collection
and evaluation of data, beginning at the process
development stage and continuing through the
production phase, which ensure that the
manufacturing processes - including
equipment, buildings, personnel and materials -
are capable of achieving the intended results on
a consistent and continuous basis.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 3
4. Related terms…
Validation: Usually applies to a process. It is
the overall action of proving, in accordance with
the principles of GMP, that any process,
equipment, material, activity or system actually
results in a test or process that will perform as
the user has specified.
Qualification: Usually applies to equipment. It
is the stepwise action of proving that any
particular premises, systems and/or piece of
equipment will actually lead to the expected
results
(Qualification is a part of validation. Validation will
include other parts such as SOPs for all the operations
associated with the equipment and training on the use
of the equipment).
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 4
5. Qualification (Equipment validation)
It is performed to ensure that equipment
produces consistent results with minimal
variation without compromising the integrity of
the product and the persons operating the
equipment.
It is performed to establish confidence that
process equipment and ancillary systems are
capable of consistently operating within
established limits & tolerance.
It is generally divided into five parts of
qualification.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 5
6. Various phases of
Qualification
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Requalification (RQ)
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 6
8. Design Qualification (DQ)
Basically is presets the specification required for the
equipment.
It defines the functional and operational
specifications of instrument & details for the
conscious decisions in the selection of the supplier.
It is performed prior to the equipment purchase and
describes the features required for the equipment to
installation.
The Design Qualification is the only document that
is going to confirm that the design will work. It must
be carried out by Qualified people who can challenge
the design performance.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 8
9. Key Considerations
Equipment capabilities:
Speed
Capacity
Temperature
Requirements:
Voltage
Size limitation
Operational specifications
Features:
Self Calibrating
Service Contracts
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 9
10. List of steps to be included in
DQ
Description of analysis problem
Description of intended use of the equipment, its
environment.
Preliminary selection of the functional and
performance specifications.
Supplier selection.
Final selection of equipment.
Final selection of supplier and equipment.
Development & documentations of specifications
4/16/2013 Department of Pharmaceutical Technology,
LJ institute of Pharmacy,Ahmedabad 10
11. It generally indicates the requirements that the
equipments must meet in order to work specifically.
FOR EXAMPLE
Equipment description eg A500/540/560 Automatic
Centrifuge
Specification
Reasons for selection of this model
Electrical requirements/ losses
Tolerance/performance
Maintenance/Cleaning
Other
Person responsible for this selection
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 11
12. Installation Qualification
Installation Qualification (IQ) execution verifies that
the equipment and its ancillary systems or sub-
systems are present and have been installed in
accordance with installation drawings and or
specifications.
It established that the instrument is received as
designed and specified, that it properly installed in
the selected environment & this enviroment is
suitable for the operation and use of instrument.
It requires the team effort by
The vendor
The operating department
The project team
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 12
13. IQ should be performed on all new or modified
facilities, systems and equipments.
FDA states that “IQ includes examination of
equipment design; determination of calibrations,
maintenance and adjustment requirements; &
identifying critical equipment features that
could affect the process and product,
Information obtained from these studies should
be used to establish SOP’s covering equpiment
calibrations, maintenance, monitoring and
control ”
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 13
14. Key Considerations
All unit operations are installed as per
specifications & design drawing.
Support systems like instrument calibration
programs, preventive maintenance procedures
& obeying SOP’s are addressed.
Verification that established specification have
been complied during construction &
installation.
Verification of construction
materials, examination and documentation of
welds.
Inspection for dead legs, pipe slopes.
Verification of SS pasivation.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 14
15. Verify that the equipment complies with
National electrical codes
Verify that all alarms and visual displays are
operational and correct.
Verify that if appropriate, the correct versions of
software are used.
Identify and verify that serial numbers and
model number of all equipment or component
parts is as listed in the installation
documentation.
Review all calibration certificates for the
equipment.
Verify that the ambient conditions are
appropriate for the operation of the equipment.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 15
16. Also following has to be
checked
Delivery date?
Manual received? (hardcopy/Electronic format)
Location for installation
Name of installer.
Power up worked? (Y/N)
Self checked passed? (Y/N)
Service/ Calibration plans established(Details)
Other
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 16
17. Ensure
voltages are
correct.
Ensure
power is
supplied to
all
equipment.
Verify
operation of
lights and
display.
Ensure
floor loading
is even.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 17
18. Operational Qualification
The QO is a process of demonstrating that an
instrument will function according to its
operational specification in the selected
environment.
includes a review of the operating manual and
verification that all functional aspects of the
equipment are performing as intended
throughout all anticipated operating ranges.
(This is a good time to start writing the SOPs
pertaining to the equipment.)
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 18
19. Key Considerations
Testing of alarms.
Testing of interlocks and permissive conditions.
Testing of database or data storage integrity.
Verification & review of the functionality of the
equipment with GMP regulations.
Challenge of software, where required;
Testing of security levels to prevent
unauthorized access;
Testing to verify and document Power loss
Recovery.
Testing of all interfaces between separate pieces
of equipment.
Testing for Electromagnetic interference and
compatibility.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 19
20. Also…
Describe the specification to be tested.
Drying temperature, Paddle/basket rpm
Accuracy of all the specification
Has equipment been calibrated?
By whom (attached documented evidence)
Has an SOP been written?
If not then do it right now before usage of equipment.
Process description
Details of process
Study critical parameters.
Temperature, chopper, baffles etc
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 20
21. Operational Qualification is
essentially acceptance testing
and should serve as the basis
for final payment.
So imagine the importance of
this step…
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 21
22. Performance Qualification
(PQ)
PQ is the process of demonstrating that an
instrument consistently performs according to
the specification appropriate for its routine use.
PQ is performed after successful completion of
the IQ & OQ.
The testing verifies that the performance
specified in the Design Specification is being
delivered.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 22
23. Key considerations
It should be performed under conditions that are
similar to routine sample analysis.
PQ should be performed on the daily basis or
whenever the equipment is being used.
Generally, PQ can mean suitable testing of
equipment, where critical key system parameters are
measured and compared with documented preset
limits.
Definition of performance criteria and test
procedures.
Determination of the test intervals.
Everyday
Every time the system is used
Before, between, after series of runs
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 23
24. Once the validation team has completed all the
steps (DQ,IQ,OQ,PQ) of equipment, the
equipment is said to be validated.
Validation individual will circulate the
completed documents for final comments and
approval. Any comments or correction by the
sign off committee will be followed by validation
individual.
Once the documents are signed off, the
validation individual will transfer all documents
to operating department of the equipment.
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 24
25. Requalification (RQ)
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 25
26. References
Parikh R K, Makwana Vijay, “Validation of
pharmaceutical process” LM college of
Pharmacy,Ahmedabad.
www.ncsu.edu/checs/media/Validation_Tutorial.p
pt/ accesed at 15th April 2013
www.gmpsop.com/.../val-
090_equipment_validation_guideline_sam.../
accesed at 15th April 2013
www.askaboutvalidation.com/.../forumdisplay.php
?...EQUIPMENT-.../ acessed at 15th April 2013
www.pharmout.com.au/services/validation/equip
ment-validation.shtml/accesed at 15th April 2013
Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 26