The document discusses the process of equipment qualification which includes design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). DQ establishes that the equipment design meets predefined user requirements. IQ demonstrates that equipment has been properly installed. OQ shows that equipment can consistently operate within defined parameters. PQ shows that equipment can consistently meet performance standards under real-world conditions. The document provides details on the documentation and tests required for each qualification step.
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
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
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
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
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
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”.
Autoclave
Principle of Autoclave
Construction of Autoclave
Working of Autoclave
Qualification of Autoclave
Installation Qualification
Operational Qualification
Performance Qualification
References
In this slide contains definition, validation method of HVAC
Presented by: V NABI RASOOL (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
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)
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
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”.
Autoclave
Principle of Autoclave
Construction of Autoclave
Working of Autoclave
Qualification of Autoclave
Installation Qualification
Operational Qualification
Performance Qualification
References
In this slide contains definition, validation method of HVAC
Presented by: V NABI RASOOL (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
In this slide contains definition, validation plan, types of Qualification of Dry Powder Mixture.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
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)
ICH guidelines for validation Of Equipments by Nikita Sahu[1].pptxNikitaSahu39
VALIDATION- As per WHO,
Validation means providing documented evidence that any procedure, process, activity or system actually leads to the expected results.
As per FDA , Validation is establishing documented evidence, which provides a high degree of assurance that a specific process will produce a product meeting its pre determined specification & quality attributes.
validation is a technique of validating the final product either starting from the raw material or within the process, its all types cover the methods of validation and sequence in the product development.
About
Indigenized remote control interface card suitable for MAFI system CCR equipment. Compatible for IDM8000 CCR. Backplane mounted serial and TCP/Ethernet communication module for CCR remote access. IDM 8000 CCR remote control on serial and TCP protocol.
• Remote control: Parallel or serial interface.
• Compatible with MAFI CCR system.
• Compatible with IDM8000 CCR.
• Compatible with Backplane mount serial communication.
• Compatible with commercial and Defence aviation CCR system.
• Remote control system for accessing CCR and allied system over serial or TCP.
• Indigenized local Support/presence in India.
• Easy in configuration using DIP switches.
Technical Specifications
Indigenized remote control interface card suitable for MAFI system CCR equipment. Compatible for IDM8000 CCR. Backplane mounted serial and TCP/Ethernet communication module for CCR remote access. IDM 8000 CCR remote control on serial and TCP protocol.
Key Features
Indigenized remote control interface card suitable for MAFI system CCR equipment. Compatible for IDM8000 CCR. Backplane mounted serial and TCP/Ethernet communication module for CCR remote access. IDM 8000 CCR remote control on serial and TCP protocol.
• Remote control: Parallel or serial interface
• Compatible with MAFI CCR system
• Copatiable with IDM8000 CCR
• Compatible with Backplane mount serial communication.
• Compatible with commercial and Defence aviation CCR system.
• Remote control system for accessing CCR and allied system over serial or TCP.
• Indigenized local Support/presence in India.
Application
• Remote control: Parallel or serial interface.
• Compatible with MAFI CCR system.
• Compatible with IDM8000 CCR.
• Compatible with Backplane mount serial communication.
• Compatible with commercial and Defence aviation CCR system.
• Remote control system for accessing CCR and allied system over serial or TCP.
• Indigenized local Support/presence in India.
• Easy in configuration using DIP switches.
Hierarchical Digital Twin of a Naval Power SystemKerry Sado
A hierarchical digital twin of a Naval DC power system has been developed and experimentally verified. Similar to other state-of-the-art digital twins, this technology creates a digital replica of the physical system executed in real-time or faster, which can modify hardware controls. However, its advantage stems from distributing computational efforts by utilizing a hierarchical structure composed of lower-level digital twin blocks and a higher-level system digital twin. Each digital twin block is associated with a physical subsystem of the hardware and communicates with a singular system digital twin, which creates a system-level response. By extracting information from each level of the hierarchy, power system controls of the hardware were reconfigured autonomously. This hierarchical digital twin development offers several advantages over other digital twins, particularly in the field of naval power systems. The hierarchical structure allows for greater computational efficiency and scalability while the ability to autonomously reconfigure hardware controls offers increased flexibility and responsiveness. The hierarchical decomposition and models utilized were well aligned with the physical twin, as indicated by the maximum deviations between the developed digital twin hierarchy and the hardware.
Overview of the fundamental roles in Hydropower generation and the components involved in wider Electrical Engineering.
This paper presents the design and construction of hydroelectric dams from the hydrologist’s survey of the valley before construction, all aspects and involved disciplines, fluid dynamics, structural engineering, generation and mains frequency regulation to the very transmission of power through the network in the United Kingdom.
Author: Robbie Edward Sayers
Collaborators and co editors: Charlie Sims and Connor Healey.
(C) 2024 Robbie E. Sayers
We have compiled the most important slides from each speaker's presentation. This year’s compilation, available for free, captures the key insights and contributions shared during the DfMAy 2024 conference.
Saudi Arabia stands as a titan in the global energy landscape, renowned for its abundant oil and gas resources. It's the largest exporter of petroleum and holds some of the world's most significant reserves. Let's delve into the top 10 oil and gas projects shaping Saudi Arabia's energy future in 2024.
Final project report on grocery store management system..pdfKamal Acharya
In today’s fast-changing business environment, it’s extremely important to be able to respond to client needs in the most effective and timely manner. If your customers wish to see your business online and have instant access to your products or services.
Online Grocery Store is an e-commerce website, which retails various grocery products. This project allows viewing various products available enables registered users to purchase desired products instantly using Paytm, UPI payment processor (Instant Pay) and also can place order by using Cash on Delivery (Pay Later) option. This project provides an easy access to Administrators and Managers to view orders placed using Pay Later and Instant Pay options.
In order to develop an e-commerce website, a number of Technologies must be studied and understood. These include multi-tiered architecture, server and client-side scripting techniques, implementation technologies, programming language (such as PHP, HTML, CSS, JavaScript) and MySQL relational databases. This is a project with the objective to develop a basic website where a consumer is provided with a shopping cart website and also to know about the technologies used to develop such a website.
This document will discuss each of the underlying technologies to create and implement an e- commerce website.
Student information management system project report ii.pdfKamal Acharya
Our project explains about the student management. This project mainly explains the various actions related to student details. This project shows some ease in adding, editing and deleting the student details. It also provides a less time consuming process for viewing, adding, editing and deleting the marks of the students.
Using recycled concrete aggregates (RCA) for pavements is crucial to achieving sustainability. Implementing RCA for new pavement can minimize carbon footprint, conserve natural resources, reduce harmful emissions, and lower life cycle costs. Compared to natural aggregate (NA), RCA pavement has fewer comprehensive studies and sustainability assessments.
Welcome to WIPAC Monthly the magazine brought to you by the LinkedIn Group Water Industry Process Automation & Control.
In this month's edition, along with this month's industry news to celebrate the 13 years since the group was created we have articles including
A case study of the used of Advanced Process Control at the Wastewater Treatment works at Lleida in Spain
A look back on an article on smart wastewater networks in order to see how the industry has measured up in the interim around the adoption of Digital Transformation in the Water Industry.
Immunizing Image Classifiers Against Localized Adversary Attacksgerogepatton
This paper addresses the vulnerability of deep learning models, particularly convolutional neural networks
(CNN)s, to adversarial attacks and presents a proactive training technique designed to counter them. We
introduce a novel volumization algorithm, which transforms 2D images into 3D volumetric representations.
When combined with 3D convolution and deep curriculum learning optimization (CLO), itsignificantly improves
the immunity of models against localized universal attacks by up to 40%. We evaluate our proposed approach
using contemporary CNN architectures and the modified Canadian Institute for Advanced Research (CIFAR-10
and CIFAR-100) and ImageNet Large Scale Visual Recognition Challenge (ILSVRC12) datasets, showcasing
accuracy improvements over previous techniques. The results indicate that the combination of the volumetric
input and curriculum learning holds significant promise for mitigating adversarial attacks without necessitating
adversary training.
2. Equipment qualification is an essential step that
companies need to perform in order to ensure that
their products or services meet manufacturing and
testing requirements and international standards.
4. Validation
◦ Establishing documented evidence that provides a
high degree of assurance that a specific process will
consistently provide a product meeting its
predetermined specifications and quality attributes.
Design Qualification
◦ The documented verification that the proposed
design of the facilities, systems and equipment is
suitable for the intended purpose or documented
verification that the system design satisfies the
requirements set forth in the URS.
5. Installation Qualification
◦ The installation qualification is to demonstrate that
all the critical components of the process
equipment and support installations have been
installed appropriately and are installed to the
respective manufacturer’s or supplier’s
requirements.
Operational Qualification
◦ The OQ demonstrates whether a facility, process
equipment and sub- systems are capable of
consistently operating within established limits and
tolerances by testing compliance with design
requirements in URS.
6. Performance Qualification
◦ Performance qualification are a collection of test
cases used to verify that the system performs as
expected under simulated real-world conditions.
◦ The documented collection of activities necessary
to demonstrate that an instrument consistently
performs according to the specifications defined by
the user and is appropriate for the intended use. A
series of tests are drawn to check the performance
of the equipment.
7.
8. The installation is done as per design
specification URS. (IQ)
The operation is as per the function and
design specification in the URS. (OQ)
The performance is as per the overall
performance requirements specified in the
URS. (PQ)
FAT or SAT may be done based on risk
assessment or criticality.
9. The impact of the equipment or system shall
be assessed during risk assessment to
determine those equipment or system that
requires qualification and those equipments
which do not require qualification.
Based on risk assessment, the equipment can
be categorized as
1. Direct impact
2. Indirect impact
3. No impact
10. Having direct impact on the product quality.
E.g. Air quality, Material of construction, type
of water, autoclave, CIP systems.
Produces data, which is used to accept /
reject in process material or product.
E.g. Electronic Batch recording system.
For process control systems such as PLC and
SCADA or DCS.
11. Indirect systems are those systems whose
parts are connected to direct impact system
or are playing an important role in direct
impact systems.
E. g. labelling machine, packing machine.
No impact systems are those having no
impact on product quality.
E.g. conveyer belts, lifting and positioning
devices.
12. category Need for Qualification
activity
Qualification approach
Direct Impact system Yes URS→DQ(FAT,SAT) →
IQ→OQ→PQ
Indirect Impact system Yes URS→DQ (FAT,SAT) →
IQ & OQ, OQ& PQ (as
applicable)
No impact system No Good Engineering
practice
13. User Requirement specification shall be
prepared by the user department in co-
ordination with engineering based on
previous performance and practical
experience.
URS should contain specifications of the
system, documents required, safety design
features, Equipment/ system description.
The URS shall be approved by QA and the
same shall be submitted.
14. After approval “Uncontrolled copy” shall be
issued by QA to Engineering dept. for the
identification of vendor who meets required
specifications.
15. Design Qualification is aimed to specify the
equipment, system or facility is designed in
accordance with the requirements of the user
and good manufacturing practice(GMP)
standards.
DQ document shall be prepared, reviewed by
the manufacturer. For feasibility the same
shall be reviewed and approved by the user,
Engineering and QA department.
16. Design qualification should contain
1. Equipment/system description
2. Equipment/system technical specification
3. Review/evaluation of vendor design against the URS
4. Deficiency sheet
5. Review inclusive of follow up action (if any)
6. It should cover all the necessary diagrams and layout
7. Desired material of construction
8. Location of control panel and electrical and utility
requirement and their range.
9. After sign off, any changes made which is having
direct or indirect impact can be handled through
change control.
17. Factory Acceptance Test is carried out by
user, Engineering/projects and QA at the site
of the vendor or by video conferencing
through FAT document provided by the
vendor.
The evaluation includes
◦ Physical verification of dimensions
◦ Blower specifications
◦ Valves
◦ Safety requirements
18. Critical operation requirement
◦ By simulation or conventional function
◦ Verification of documents
◦ Overall review / inspection
◦ Any modification from approved DQ, approved
during FAT shall be incorporated in CC and
considered during IQ.
◦ FAT document shall be filed in QA department.
19. Site acceptance test shall be performed by
User, Engineering and QA at site after the
recipient of equipment/system in presence of
vendor to ensure that the equipment /
system is in good state, no components are
damaged and meeting the design as per URS.
It involves inspection of major or sub
components in packed or unpacked
condition, alignment checks of various
components.
20. SAT also verifies the supporting utilities,
pendants availability and adequacy etc at site.
Points which are left out in FAT can be
assessed in SAT test.
21. IQ document shall be prepared by
Engineering department in coordination with
user and QA.
IQ is carried out to ensure the premises
supporting utilities and equipment have been
built and installed in compliance with their
approved design specification (DQ) and
manufacturers manual and recommendations.
22. The documents used for IQ should contain
but not limited to
◦ Equipment description & identification
◦ List of reference documents & drawings
◦ Pre-requisites
◦ Checklist for inspection of Equipment on receipt
◦ List of Spares received
◦ Location suitability
◦ Verification of major components
◦ Verification of installation
◦ Identification of equipment / instrument for
calibration and preventive maintenance.
23. ◦ Material of construction
◦ Utilities/service connection checks
◦ Cleaning & passivation
◦ Manufacturer certificates
◦ Identification of product contact surfaces
◦ Deficiency sheet
Any non compliance observed during Installation
qualification shall be recorded.
24. OQ shall be performed to verify that the
equipment, instrument, utility and system,
operates in accordance with design
specification, manufacturer recommendations
and cGMP requirements.
Operational Qualification shall be prepared by
user department in coordination with
Engineering department and Quality
assurance.
25. OQ shall be prepared based on the DQ and
manufacturers manual and recommendation.
Operational testing to be done, whenever
possible to challenge the system, to the limits
of anticipated operating conditions.
OQ shall be done without any load, if its not
possible then loaded trials can be taken.
It also should test the performance of the
equipments components such as motors,
blowers, sensors, functioning of interlocks,
safety features.
26. The OQ document should contain but not
limited to
◦ Equipment operating principle
◦ Pre-requisites for operational qualification
◦ Methodology for operational qualification
◦ Calibration review of critical instruments like
sensor, probes, gauges, recorders, air flow rates.
◦ Directions, pressure, temperature etc and referring
to standard test instrument.
◦ Operational verification of equipment i.e
operational testing as per process and system.
27. ◦ Verifications of Draft SOPs & training.
◦ Testing of safety features and interlocks
◦ Power failure verification
◦ Validation of PLC
◦ Training to personnel for maintenance and operation
◦ Deficiency sheet
◦ When OQ documents compiled by vendor the documents
shall be evaluated by the QA.
◦ The completion of successful OQ should allowed the
finalization of SOPs and cleaning procedures, operator
training and PM requirement.
28. PQ demonstrates that how the
equipment/system will perform when
challenged under simulated or actual
production conditions.
A series of tests are designed to demonstrate
that the equipment/system are capable to
perform consistently and meet required
specifications under routine production
operations.
29. Performance qualification document shall be
prepared by QA (Validation) in coordination
with user department and Engineering
department.
Performance qualification of the equipment
shall be prepared based on User’s
requirement and design qualification/
technical specification provided by the
manufacturer.
30. PQ document should contain but not limited
to
◦ Pre-requisites for PQ
◦ Methodology for performance qualification
◦ Performance verification tests
◦ Deficiency sheet
Any significant changes it approved DQ/IQ/OQ/PQ
documents during execution should be documented
as a deviation and the same should be justified.
31. Conditional approval for proceeding to next
phase of qualification can be given when
certain acceptance criteria or deviation is not
fully addressed, the same shall be addressed
through documented evidence of no
significant impact on the next activity.
Qualification activities wherein location needs
to be identified for placement of data loggers
or sensors, the schematic layouts for sensor
location should be mentioned in validation
protocol for better clarity.
32. Requalification shall be carried out in case
◦ Modification in the equipment which directly or
indirectly affects the quality of the products
processed in the equipment
◦ Relocation of the equipment
◦ Equipment up gradation
◦ Any other changes that deemed necessary for
requalification through change management
system.