This document discusses quality assurance techniques in pharmaceutical manufacturing. It defines quality, quality assurance, and quality control, and describes the differences and responsibilities of quality assurance and quality control. Key points covered include in-process quality control, master production and control records, and batch production and control records. The document is presented by Shrikant Kavitake from Dattakala College of Pharmacy.
Quality Assurance and Quality Management System, QUALITY CONTROL
cGMP (GOOD MANUFACTURING PRACTICES
ELEMENTS OF QUALITY MANAGEMENT SYSTEM
PURPOSES OF QUALITY MANAGEMENT SYSTEMS
CONCEPT OF QUALITY ASSURANCE
RESPONSIBILITIES OF QA
GMP COVERS
quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem
Quality management in the drug industry
Why quality is important in pharmaceuticals?
Impacts of ignorance on quality
Quality control
Role of quality control in pharmaceutical industry
Objectives of quality control
Components of quality control
Functions of qc in pharmaceutical industry
Quality assurance
Total quality management
Characteristics of tqm
Benefits of tqm:
Quality Assurance and Quality Management System, QUALITY CONTROL
cGMP (GOOD MANUFACTURING PRACTICES
ELEMENTS OF QUALITY MANAGEMENT SYSTEM
PURPOSES OF QUALITY MANAGEMENT SYSTEMS
CONCEPT OF QUALITY ASSURANCE
RESPONSIBILITIES OF QA
GMP COVERS
quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem
Quality management in the drug industry
Why quality is important in pharmaceuticals?
Impacts of ignorance on quality
Quality control
Role of quality control in pharmaceutical industry
Objectives of quality control
Components of quality control
Functions of qc in pharmaceutical industry
Quality assurance
Total quality management
Characteristics of tqm
Benefits of tqm:
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Quality assurance is a wide ranging concept covering all matters that individually and collectively influence the quality of product.
It is the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for the intended use.
Assurance of product quality is derived from careful attention of factors including selection of quality parts and materials, adequate product and process design, control of the process, and in-process and end-product testing.
Quality assurance and quality management concepts.pptxGayatriBahatkar1
UNIT – I
Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
Quality assurance is a wide ranging concept covering all matters that individually and collectively influence the quality of product.
It is the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for the intended use.
Assurance of product quality is derived from careful attention of factors including selection of quality parts and materials, adequate product and process design, control of the process, and in-process and end-product testing.
Quality assurance and quality management concepts.pptxGayatriBahatkar1
UNIT – I
Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
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.
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
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.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
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.
Pride Month Slides 2024 David Douglas School District
Chapter 1 QA & QC, ROLES AND RESPONISIBILITIES
1. 4.8.7 T QUALITY ASSURANCE
TECHNIQUES
SAVITRIBAI PHULE PUNE UNIVERSITY
Syllabus of Final Year B. Pharmacy
(EFFECTIVE FROM ACADEMIC YEAR 2018-19)
PATTERN 2015
2. Hello!
I am Shrikant Kavitake
M Pharm (Pharmaceutics)
DATTAKALA COLLEGE OF PHARMACY
Swami-Chincholi, Daund, Pune.
2
3. 1.
Introduction
3
Quality
Quality Assurance
Quality Control
IPQC
Responsibilities
Master Production
and Control Record
(MPCR)
Batch Production
and Control Record
(BPCR)
4. ‘’
Definition;
Quality is that the drug or drug product meets
its prespecified quality attributes or regulatory
specifications.
OR
It has also been stated that a drug
manufactured in compliance with cGMP is a
high quality drug or drug product.
4
5. Quality Assurance;
▣ According to WHO, quality assurance is a wide
ranging concept covering all matters that individually
or collectively influence the quality of a pharmaceutical
product.
▣ Quality assurance can be divided into major areas:
development, quality control, production, distribution,
and inspections.
▣ ISO 9000 defines as "part of quality management
focused on providing confidence that quality
requirements will be fulfilled"
5
6. Quality Control;
▣ ISO 9000 defines quality control as "A part of quality
management focused on fulfilling quality requirements".
▣ It is that part of GMP concerned with sampling,
specification & testing, documentation & release
procedures which ensure that the necessary & relevant
tests are performed & the product is released for use only
after ascertaining it’s quality.
6
7. Difference between QA and QC:
Definition
▣ QA is a set of activities for
ensuring quality in the
processes by which products
are developed.
▣ QA is a managerial tool
defects in the actual products
produced.
7
▣ QC is a set of activities for
ensuring quality in products.
The activities focus on
identifying defects in the
actual products produced.
▣ QC is a corrective tool
8. Difference between QA and QC: Goals
▣ QA aims to prevent defects
with a focus on the process
used to make the product. It is
a proactive quality process.
▣ The goal of QA is to improve
development and test
processes so that defects do
not arise when the product is
being developed.
8
▣ QC aims to identify (and
correct) defects in the finished
product. Quality control,
therefore, is a reactive process.
▣ The goal of QC is to identify
defects after a product is
developed and before it's
released.
9. Difference between QA and QC: Work
▣ Prevention of quality problems
through planned and
systematic activities including
documentation.
▣ Establish a good quality
management system and the
assessment of its adequacy.
Periodic conformance audits
of the operations of the
system.
9
▣ The activities or techniques
used to achieve and maintain
the product quality, process
and service.
▣ Finding & eliminating sources
of quality problems through
tools & equipment so that
customer's requirements are
continually met
10. Difference between QA and QC:
Responsibility
▣ Everyone on the team
involved in developing the
product is responsible for
quality assurance.
▣ Verification is an example of
QA.
10
▣ Quality control is usually the
responsibility of a specific
team that tests the product for
defects.
▣ Validation is an example of QC.
11. Responsibilities of QA
▣ The QA department is responsible for ensuring that the
quality policies adopted by a company are followed.
▣ It helps to identify and prepare the necessary SOPs
relative to the control of quality.
▣ It must determine that the product meets all the
applicable specifications and that it was manufactured
according to the internal standards of GMP.
▣ QA also holds responsible for quality monitoring or
audit function.
11
12. Contin…
▣ QA functions to assess operations continually and to
advise and guide them towards full compliance with all
applicable internal and external regulations.
12
13. Responsibilities of QC
▣ QC is responsible for the day-to-day control of quality
within the company.
▣ This department is responsible for analytical testing of
incoming raw materials and inspection of packaging
components, including labelling.
▣ They conduct in-process testing when required,
perform environmental monitoring, and inspect
operations for compliance.
▣ They also conduct the required tests on finished dosage
form. 13
14. Contin…
▣ QC plays a major role in the selection of qualified
vendors from whom raw materials are purchased.
Testing of representative samples is required, and in
many cases, an audit of vendor’s operations is
necessary to determine their suitability and degree of
compliance with GMPs prior to their being approved.
▣ The environmental areas for manufacturing of various
dosage forms are tested and inspected by QC
department.
14
16. Role Of QA in IPQC
16
There are some critical steps to be followed in this:
▣ QA before start-up
• Environmental and microbiologic control and
sanitation
• Manufacturing Working Formula Procedures
• Raw Materials
• Manufacturing Equipment
17. Contin…
▣ QA at start-up
Raw Material Processing
Compounding
Packaging Materials Control
Labels Control
Finished Product Control
17
19. Master Production and Control
Records (MPCR)
19
1. Name of the material and reference
2. Complete list of the materials and quality
characteristics
3. Quantities of each materials with identification
4. Production location and equipment used
5. Production instructions
6. Cross references and precautions to be followed
7. Storage conditions
20. Batch Production and Control
Records (BPCR)
20
1. BPCR contains detailed information of production
2. BPCR should be numbered with a unique
identification number, dated and signed
3. Written procedure for investigation for critical
process and batch failure
4. Specifications should be identified
5. Completion of significant steps (Process deviation,
OOS, Critical process parameters, Sampling, In-
process results, yield and results)