Audit of vendors and production department
•Download as PPTX, PDF•
41 likes•4,117 views
production department auidts cheaklists
Report
Share
Report
Share
Recommended
Role of quality system and audits in pharmamaceutical
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
AUDITING OF AUALITY ASSURANCE AND ENGINEERING DEPARTMENT
its about the auditing and quality assurance of engineering department
CHAPTER-1 DEFICIENCIES.pdf
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”.
Audit of vendors and Production department
Detailed about the Production Department and Vendor Audit Which is use as in Pharmaceutical Industries.
Role of quality systems and audits in pharmaceutical manufacturing environment
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.
Recommended
Role of quality system and audits in pharmamaceutical
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
AUDITING OF AUALITY ASSURANCE AND ENGINEERING DEPARTMENT
its about the auditing and quality assurance of engineering department
CHAPTER-1 DEFICIENCIES.pdf
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”.
Audit of vendors and Production department
Detailed about the Production Department and Vendor Audit Which is use as in Pharmaceutical Industries.
Role of quality systems and audits in pharmaceutical manufacturing environment
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.
QUALIFICATION OF MANUFACTURING EQUIPMENTS
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Aseptic Process Technology.pptx
To avoid contamination, the aseptic technique is the method of reducing or removing contaminants from entering the operative field in surgery or medicine.
USFDA guidelines on process validation a life cycle approach
validation on lifecycle approach as per as the USFDA
Auditing in Solid Oral Dosage Form Production Department
A presentation for Pharmacy Students on the topic Auditing in Solid Oral Dosage Form Production Department and Checklist example.
Validation of compressed air and nitrogen
Brief discussion about validation of compressed air and nitrogen with specific examples in detail.
Comparison of compressed air and nitrogen
Auditing of capsule, sterile production and packaging
Knowledge about auditing of capsule, sterile production and packaging
Qualification of Dissolution Test Apparatus and Validation of Utility System
Qualification of Dissolution Test Apparatus and Validation of Utility SystemAkshay Trivedi , Maliba Pharmacy College
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.Auditing of Granulation Operation in Dry Production Area
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Qualification of laboratory equipments
equipments include hardness tester, friability tester, tap density tester, disintegration test apparatus and dissolution test apparatus
Cleaning validation
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.
Auditing of vendors and production department
Auditing of vendors and production department quality assurance (QA) M.pharm 2 SEM 1 year of audit and regulatory compliance of
Audit and regulatory compliance
auditing procedure
information gathering sources in auditing
audit planning procedure
Validation master plan
In this slide contains details about Validation master plan.
Presented by: HIMA BINDHU (Department of pharmaceutical analysis).RIPER, anantapur
cGMP regulations & QA function.pptx
Introduction
cGMP regulations
Subparts of 21 CFR part 11
Duties of QC unit under cGMP regulations
Quality assurance function
Question
References
Digital Artifact 1 - 10VCD Environments Unit
Digital Artifact 1 - 10VCD Environments Unit - NGV Pavilion Concept Design
1.4 modern child centered education - mahatma gandhi-2.pptx
Child centred education is an educational approach that priorities the interest, needs and abilities of the child in the learning process.
More Related Content
What's hot
QUALIFICATION OF MANUFACTURING EQUIPMENTS
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
Aseptic Process Technology.pptx
To avoid contamination, the aseptic technique is the method of reducing or removing contaminants from entering the operative field in surgery or medicine.
USFDA guidelines on process validation a life cycle approach
validation on lifecycle approach as per as the USFDA
Auditing in Solid Oral Dosage Form Production Department
A presentation for Pharmacy Students on the topic Auditing in Solid Oral Dosage Form Production Department and Checklist example.
Validation of compressed air and nitrogen
Brief discussion about validation of compressed air and nitrogen with specific examples in detail.
Comparison of compressed air and nitrogen
Auditing of capsule, sterile production and packaging
Knowledge about auditing of capsule, sterile production and packaging
Qualification of Dissolution Test Apparatus and Validation of Utility System
Qualification of Dissolution Test Apparatus and Validation of Utility SystemAkshay Trivedi , Maliba Pharmacy College
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.Auditing of Granulation Operation in Dry Production Area
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Qualification of laboratory equipments
equipments include hardness tester, friability tester, tap density tester, disintegration test apparatus and dissolution test apparatus
Cleaning validation
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.
Auditing of vendors and production department
Auditing of vendors and production department quality assurance (QA) M.pharm 2 SEM 1 year of audit and regulatory compliance of
Audit and regulatory compliance
auditing procedure
information gathering sources in auditing
audit planning procedure
Validation master plan
In this slide contains details about Validation master plan.
Presented by: HIMA BINDHU (Department of pharmaceutical analysis).RIPER, anantapur
cGMP regulations & QA function.pptx
Introduction
cGMP regulations
Subparts of 21 CFR part 11
Duties of QC unit under cGMP regulations
Quality assurance function
Question
References
What's hot (20)
USFDA guidelines on process validation a life cycle approach
USFDA guidelines on process validation a life cycle approach
Auditing in Solid Oral Dosage Form Production Department
Auditing in Solid Oral Dosage Form Production Department
Auditing of capsule, sterile production and packaging
Auditing of capsule, sterile production and packaging
Quality by Design and Process Analytical Technology
Quality by Design and Process Analytical Technology
Qualification of Dissolution Test Apparatus and Validation of Utility System
Qualification of Dissolution Test Apparatus and Validation of Utility System
Auditing of Granulation Operation in Dry Production Area
Auditing of Granulation Operation in Dry Production Area
Recently uploaded
Digital Artifact 1 - 10VCD Environments Unit
Digital Artifact 1 - 10VCD Environments Unit - NGV Pavilion Concept Design
1.4 modern child centered education - mahatma gandhi-2.pptx
Child centred education is an educational approach that priorities the interest, needs and abilities of the child in the learning process.
special B.ed 2nd year old paper_20240531.pdf
Instagram:-
https://instagram.com/special_education_needs_01?igshid=YmMyMTA2M2Y=
WhatsApp:-
https://chat.whatsapp.com/JVakNIYlSV94x7bwunO3Dc
YouTube:-
https://youtube.com/@special_education_needs
Teligram :- https://t.me/special_education_needs
Slide Shere :-
https://www.slideshare.net/shabnambano20?utm_campaign=profiletracking&utm_medium=sssite&utm_source=ssslideview
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...
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
The Challenger.pdf DNHS Official Publication
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!
Best Digital Marketing Institute In NOIDA
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.
2024.06.01 Introducing a competency framework for languag learning materials ...
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.
Digital Artifact 2 - Investigating Pavilion Designs
Digital Artifact 2 - Pavilions
NGV Architecture Commission Competition
MPavilion Commission Competition
Other Pavilion Designs
The Diamonds of 2023-2024 in the IGRA collection
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
Unit 8 - Information and Communication Technology (Paper I).pdf
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Mule 4.6 & Java 17 Upgrade | MuleSoft Mysore Meetup #46
Mule 4.6 & Java 17 Upgrade | MuleSoft Mysore Meetup #46
Event Link:-
https://meetups.mulesoft.com/events/details/mulesoft-mysore-presents-exploring-gemini-ai-and-integration-with-mulesoft/
Agenda
● Java 17 Upgrade Overview
● Why and by when do customers need to upgrade to Java 17?
● Is there any immediate impact to upgrading to Mule Runtime 4.6 and beyond?
● Which MuleSoft products are in scope?
For Upcoming Meetups Join Mysore Meetup Group - https://meetups.mulesoft.com/mysore/
YouTube:- youtube.com/@mulesoftmysore
Mysore WhatsApp group:- https://chat.whatsapp.com/EhqtHtCC75vCAX7gaO842N
Speaker:-
Shubham Chaurasia - https://www.linkedin.com/in/shubhamchaurasia1/
Priya Shaw - https://www.linkedin.com/in/priya-shaw
Organizers:-
Shubham Chaurasia - https://www.linkedin.com/in/shubhamchaurasia1/
Giridhar Meka - https://www.linkedin.com/in/giridharmeka
Priya Shaw - https://www.linkedin.com/in/priya-shaw
Shyam Raj Prasad-
https://www.linkedin.com/in/shyam-raj-prasad/
"Protectable subject matters, Protection in biotechnology, Protection of othe...
Protectable subject matters, Protection in biotechnology, Protection of other biological materials, Ownership and period of protection
Supporting (UKRI) OA monographs at Salford.pptx
How libraries can support authors with open access requirements for UKRI funded books
Wednesday 22 May 2024, 14:00-15:00.
Chapter 3 - Islamic Banking Products and Services.pptx
Chapter 3 - Islamic Banking Products and Services.pptxMohd Adib Abd Muin, Senior Lecturer at Universiti Utara Malaysia
This slide is prepared for master's students (MIFB & MIBS) UUM. May it be useful to all.A Strategic Approach: GenAI in Education
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.
Recently uploaded (20)
1.4 modern child centered education - mahatma gandhi-2.pptx
1.4 modern child centered education - mahatma gandhi-2.pptx
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...
Multithreading_in_C++ - std::thread, race condition
Multithreading_in_C++ - std::thread, race condition
2024.06.01 Introducing a competency framework for languag learning materials ...
2024.06.01 Introducing a competency framework for languag learning materials ...
Digital Artifact 2 - Investigating Pavilion Designs
Digital Artifact 2 - Investigating Pavilion Designs
Unit 8 - Information and Communication Technology (Paper I).pdf
Unit 8 - Information and Communication Technology (Paper I).pdf
Mule 4.6 & Java 17 Upgrade | MuleSoft Mysore Meetup #46
Mule 4.6 & Java 17 Upgrade | MuleSoft Mysore Meetup #46
"Protectable subject matters, Protection in biotechnology, Protection of othe...
"Protectable subject matters, Protection in biotechnology, Protection of othe...
Chapter 3 - Islamic Banking Products and Services.pptx
Chapter 3 - Islamic Banking Products and Services.pptx
Audit of vendors and production department
- 1. Presented by, Sanmati Dilip Shete. M.Pharm.first.year Department of quality Assurance. Rajarambapu College Of Pharmacy , Kasegaon.
- 2. Checklist for Tableting Process 3/27/2018 2
- 3. 3/27/2018 3
- 4. 3/27/2018 4
- 6. 3/27/2018 6
- 7. 3/27/2018 7
- 8. Checklist for Sterile Preparation 3/27/2018 8
- 9. 3/27/2018 9
- 10. 3/27/2018 10
- 11. 3/27/2018 11
- 12. 3/27/2018 12
- 13. 3/27/2018 13
- 14. 3/27/2018 14