QA and QC are related but distinct concepts in quality management. QA refers to the overall system that aims to prevent defects through processes, while QC tests products to identify defects. QA is a preventative system involving all employees to ensure quality standards are met throughout development. In contrast, QC is reactive and conducted by a specialized team to detect defects in finished products before release. Both work together to continually meet customer requirements, with QA focusing on building quality in from the start and QC checking for quality along the way.
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
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.
In this slide contains Introduction, levels of cleaning, mechanism, sampling method of cleaning validation.
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
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.
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.
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
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.
In this slide contains Introduction, levels of cleaning, mechanism, sampling method of cleaning validation.
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
ANALYSIS OF RAW MATERIALS, FINISHED PRODUCTS, PACKAGING MATERIALS, IPQC, CPCS...Khadeeja6
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It is basically the chemical ingredients of a process. starting material, in production of final product.
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Marketable product, transportable pack, salable pack
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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.
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.
This presentation includes detail about cleaning levels,equipments for cleaning validation , steps for cleaning method validation and analytical method validation used for cleaning.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
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
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.
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BugRaptors has domain expertise team skilled in working with various test models like Sequential & Agile. We provide users with quality consultancy. They help users from all over the world to clear all their doubts and issues on any type or kind of testing. Either it’s Automation, Security or any kind of testing, We have team which is highly experienced in all types of testing. It helps in developing great quality products. We have well experienced team of manual as well as Automation testing. The main focus of BugRaptors team is quality because the Life is better with lesser issues in it.
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Concept & evolution of qa & qc
1. CONCEPT AND EVOLUTION OF
QUALITY CONTROL & QUALITY ASSURANCE
Presented by
G.Pavani
Y17mphpa426,
Dept of pharmaceutical
analysis
Chalapathi Institute of Pharmaceutical Sciences
3. According to WHO, Quality assurance is a wide- ranging concept covering all matters that
Individually or collectively influence the quality of a product.
With regard to pharmaceuticals, quality assurance can be divided into major areas:
development, quality control, production, distribution, and inspections.
QA is a way of preventing mistakes or defects in manufactured products and avoiding
problems when delivering solutions or services to customers;
ISO 9000 defines as "part of quality management focused on providing confidence that
quality requirements will be fulfilled“.
QUALITY ASSURANCE
4. ISO 9000 defines quality control Is "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.
QUALITY CONTROL
6. Continued…..
QA QC
QA Make Sure that we are doing the right
things and in the right way
QC Make sure that result of what we have
done are what we are expecting
QA focuses on building in quality and hence
preventing defects
QC focuses on testing for the quality and
hence detecting the defects
QA deals with process QC deals with product
QA is for entire life cycle
QC is for testing part in SDLC (System
Development Life Cycle)
QA is preventive process QC is corrective process
7. QA QC
QA aims to prevent defects with a focus on
the process used to make the product. It is a
proactive quality process.
QC aims to identify (and correct) defects in
the finished product. Quality control,
therefore, is a reactive process.
The goal of QA is to improve development
and test processes so that defects do not
arise when the product is being developed.
The goal of QC is to identify defects after a
product is developed and before it's
released.
What are its goals and on what does it focus ?
8. QA QC
Prevention of quality problems through
planned and systematic activities including
documentation.
The activities or techniques used to achieve
and maintain the product quality, process
and service.
Establish a good quality management system
and the assessment of its adequacy. Periodic
conformance audits of the operations of the
system.
Finding & eliminating sources of quality
problems through tools & equipment so that
customer's requirements are continually
met.
What and how does it work ?
9. QA QC
Everyone on the team involved in
developing the product is responsible for
quality assurance.
Quality control is usually the responsibility
of a specific team that tests the product for
defects.
Verification is an example of QA. Validation is an example of QC.
Whose responsibility is it and what is the example of it?
10. Responsibilities of QA
1. Ensuring that the quality policies adopted by a company are followed.
2. It helps to identify and prepare the necessary SOPs relative to the control of quality.
3. It must determine that the product meets all the applicable specifications and that it was
manufactured according to the internal standards of GMP.
4. QA also holds responsible for quality monitoring or audit function.
5. QA functions to assess operations continually and to advise and guide them towards
full compliance with all applicable internal and external regulations.
11. Responsibilities of QC
1. QC is responsible for the day-to-day control of quality within the company.
2. This department is responsible for analytical testing of incoming raw materials and inspection
of packaging components, including labelling.
3. They conduct in-process testing when required, perform environmental monitoring, and
inspect operations for compliance.
4. They also conduct the required tests on finished dosage form.
5. 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.