Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
Expiry date , calculation of yields, production record review, change controlSantosh kumar
The responsibility of the pharmaceutical manufacturer is that the drug product should have the stated potency and therapeutic effectiveness till the end of the shelf life of the product This shelf life should be based on t
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
computer system is a latest validation system in pharmaceutical industries.
To compliance with the good laboratory practice and good manufacturing practice.
it`s part of 211CFR part 11.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
Expiry date , calculation of yields, production record review, change controlSantosh kumar
The responsibility of the pharmaceutical manufacturer is that the drug product should have the stated potency and therapeutic effectiveness till the end of the shelf life of the product This shelf life should be based on t
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
computer system is a latest validation system in pharmaceutical industries.
To compliance with the good laboratory practice and good manufacturing practice.
it`s part of 211CFR part 11.
Software testing for project report .pdfKamal Acharya
Methods of Software Testing There are two basic methods of performing software testing: 1. Manual testing 2. Automated testing Manual Software Testing As the name would imply, manual software testing is the process of an individual or individuals manually testing software. This can take the form of navigating user interfaces, submitting information, or even trying to hack the software or underlying database. As one might presume, manual software testing is labor-intensive and slow.
Understanding test environments can provide several benefits for software development teams. First, it helps to ensure that the software is tested in a realistic environment that accurately reflects the production environment. This helps to reduce the risk of unexpected issues arising when the software is released into production.
Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in the production of the device or in implementation of the device manufacturer's quality system. Any medical device software developed after June 1, 1997, regardless of its class, unless exempted in a classification regulation is subject to design controls...
Software Testing and Quality Assurance Assignment 3Gurpreet singh
Short questions :
Que 1 : Define Software Testing.
Que 2 : What is risk identification ?
Que 3 : What is SCM ?
Que 4 : Define Debugging.
Que 5 : Explain Configuration audit.
Que 6 : Differentiate between white box testing & black box testing.
Que 7 : What do you mean by metrics ?
Que 8 : What do you mean by version control ?
Que 9 : Explain Object Oriented Software Engineering.
Que 10 : What are the advantages and disadvantages of manual testing tools ?
Long Questions:
Que 1 : What do you mean by baselines ? Explain their importance.
Que 2 : What do you mean by change control ? Explain the various steps in detail.
Que 3 : Explain various types of testing in detail.
Que 4 : Differentiate between automated testing and manual testing.
Que 5 : What is web engineering ? Explain in detail its model and features.
Impurity profiling and degradent characterization {presented by shameer m.pha...ShameerAbid
these slides discuss
Impurity profiling
Degradation characterization
Stability testing & Accelerated stability testing (ICH)
Evaluation of the test (shelf life)
analytical method development
ICH vs USP definition
methods for identification
method for the isolation of the impurity
factors affecting the degradation of formulation
What is degradation characterization
general protocol of degradation conditions used for drug substance and drug product
Degradation conditions
Stress testing
Container closure system
Biological test and assay tetanus toxoid adsorbed ShameerAbid
these slides talked about the tests and assay method for tetanus toxoid adsorbed
Tetanus Toxoid
What Is Bioassay/Biological Assay?
Potency in guinea pigs and mice by the challenge
(lethal and paralysis)
Validity of the test
Validation and suitability
Other methods
Acronyms
Validation of utility system (water system)ShameerAbid
these slides talked about the validation of utility systems in pharmaceutical industries
with special emphasis on the water system
helpful for pharmaceutical student
chromatography general principles and comparison - specially about gas chrom...ShameerAbid
these sides discuss chromatography with special emphasis on gas chromatography
fundamentals
general principles
comparison of different chromatographic techniques
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.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
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.
5. Computer system validation
What is computer system validation?
Computer system validation (CVS) is often refers
to as software validation.
By Rodrigo Perez dated 11/Apr./2018
(regulated companies perform validation projects to
prove and ensure that their software or system is
performing the way it is supposed to work, and not
performing in ways that it isn’t intended to work.
*FDA definition doesn’t sound like that*
6. As FDA do not take it so-lightly
it states
“Confirmation by examination and provision of objective evidence that
software specifications conform to user needs and intended uses, and
that the particular requirements implemented through software can be
consistently fulfilled”
General Principle Of Software Validation : Final Guidance For Industry
and FDA Staff
7.
8. Must have defined user
needs and intended uses.
Examine the software to
confirm that it functions as
defined in the
requirements and that it
will be suitable for its
intended use.
(The user can be a patient,
someone in the hospital, a
lab tech, a QA engineer, a
manufacturing person)
9. there must be defined
software requirements.
Document all validation
activities and test
results.
10. Examine the software to
ensure that it meets the user
needs and defined
requirements
This could include:-
Design reviews
Code reviews
Testing, etc.
Define what the user needs
to do with the software and
how they will use the
software.
11. Confirm that the
requirements can be
consistently fulfilled (keep
in mind that not just in a
single situation).
This could include:-
Stress testing multiple
data sets,
Performance testing with
many users in many
locations,
Testing with multiple
browsers or web apps,
Testing from multiple
devices (and even mobile
apps), etc.
this Define how the
software needs to work to
enable the intended use.
12. Need to have objective
evidence of this
confirmation ( this is done
for inspections).
Document all validation
activities and test results
The examination needs to
confirm that the software
will work in all anticipated
situations.
13. Pharmaceutical companies. In the
US and most developed companies,
pharmaceutical businesses have to
undergo CSV. In particular, you need
to validate your system if your
business produces or distributes drugs
used for diagnosing or treating
diseases.
Storage and distribution providers.
Businesses that store
pharmaceuticals, biological, or cell-
and-tissue products are obliged to
complete CSV. Otherwise, the
penalties might be as high as
debarment or a criminal prosecution.
Products that sell biological. A
product can be defined
as biological if it’s made from a
therapeutic serum or a virus and used
for injury or disease prevention and
treatment. Vaccines are biological too.
Medical devices distributors. By
definition, medical devices comprise of
14. The classical V diagram is one of type methodology that is used for the
purpose of computer system validation
The classic “V Diagram” was popularized by industry organizations
such as ISPE via GAMP Guides.
15. A validation plane define the
approach and what to be
validated
It define the role and
responsibilities along with the
acceptance criteria
16. The User Requirements
Specification describes what the
user needs from the software and
how they will use it. It also
contains any critical constraints
such as regulations, safety
requirements, operational
requirements, etc.
System must track training of
lab analysts on lab
methods/techniques
System must track samples
coming into the lab
System must comply with 21
CFR 11
17. The Functional Specification
document describes how the
software needs to work and look
to meet the user needs.
The document might include
descriptions of how specific
screens and reports should
look, or describe data that
needs to be captured.
For example, the Part 11
compliance requirements might
detail how passwords or the
audit trail should work.
18. The Design Specification document is
one that contains all of the technical
elements of the software or systems.
This includes:
Database Design – file structures, field
definitions, data flow diagrams, entity
relationship diagrams
Logic/Process Design – pseudo code
for logic and calculations
Security Design – virus protection,
hacker protection
Interface Design – what data will move
from one system to another; how and
how often, and failure handling
Architecture Design – required
hardware, operating systems,
application versions, middleware, etc.
Network Requirements
Specific peripheral devices – scanners,
printers, etc.
19. In the System Build step, you
develop or purchase your
software and then configure it to
the previous specification
documents.
This step includes unit testing
and integration testing
20. The Installation Qualification
tests provide confirmation that
the software or system is
installed and setup according to
the Design Specification.
Usually the software is first
installed in a test or validation
environment, but there can be
exceptions in situations such as
manufacturing.
21. Operational Qualification testing
is often referred to as Functional
Testing or System Testing.
OQ tests confirm that all
functionality defined in the
Functional Specification is
present and working correctly,
and that there are no bugs.
OQ tests can also include
confirmation of any design
elements not tested during IQ,
such as configuration, are
working as specified.
22. Performance Qualification
testing is often called User
Acceptance testing. PQ testing
confirms that the software will
meet the users’ needs and is
suitable for their intended use,
as defined in the User
Requirements Specification.
Testing can follow Use Cases,
SOPs, user-defined scenarios,
etc. For simple software like
reports or spreadsheets, OQ
and PQ testing are often
combined.
23. The last step in this validation
method is to write the Validation
Report, often called the
Validation Summary or System
Certification.
This report provides
confirmation that all activities
specified in the validation plan
have been completed.
The Validation Report
summarizes the testing results
and provides confirmation that
all acceptance criteria have
been met and the software is
ready for deployment.
24. Computer system validation helps
to ensure that both new and
existing computer systems
consistently fulfill their intended
purpose and produce accurate and
reliable results that enable
regulatory compliance, fulfillment
of user requirements, and the
ability to discern invalid and/or
altered records.
CSV utilizes both static and
dynamic testing activities that are
conducted throughout the
software development lifecycle
(SDLC)