report 2014
•
0 likes•60 views
This document contains exam results for a student. It shows the student's university number, qualification program of B Pharm, and results for 11 modules taken between 2014-2015. The student received distinction marks over 75% in 7 modules and passed 2 modules with marks between 58-68%.
Report
Share
Report
Share
Download to read offline
Recommended
report 2015
Student received exam results for 12 modules taken in their Qualification program in Pharmacy. They received Distinctions for 5 modules, with marks ranging from 79-80, and Passed grades for 7 modules, with marks ranging from 68-75. Overall the student performed well, with above average marks in most modules.
9 150928065812-lva1-app6892 gmp
This document discusses Good Manufacturing Practices (GMP) for pharmaceuticals. It introduces GMP, explaining that GMP ensures pharmaceutical products are consistently manufactured and controlled to quality standards for their intended use. It also discusses the relationships between quality assurance (QA), GMP, and quality control (QC), noting that QA oversees the whole system, GMP ensures consistent manufacturing quality, and QC tests samples to ensure quality. Finally, it provides an overview of key aspects of GMP, including facilities, equipment, packaging, and documentation.
Hệ thống chất lượng dược phẩm GMP EU
Hệ thống chất lượng dược phẩm trong GMP EU. Xem thêm các tài liệu khác trên kênh của Công ty cổ phần Tư vấn Thiết kế GMP EU
Manufacturing Quality Branch – 2015 Achievements and Challenges
In 2015, the Manufacturing Quality Branch achieved improvements in GMP clearance times and inspection performance while also facing ongoing challenges. Key accomplishments included:
- Reducing median GMP clearance processing times from 18.8 weeks to 4.1 weeks through process improvements and increased communication.
- Completing 92% of domestic initial inspections and 94% of domestic reinspections within target timelines.
Looking ahead to 2016, plans include further streamlining the GMP clearance and inspection processes through application improvements, clearer sponsor expectations, and rewarding consistent compliance through less frequent inspections for high-performing facilities. The goal is more predictable timelines and reduced regulatory burden.
Gsp china
On January 22, 2013 the China SFDA published a Good Supply Practice guidance that will be implemented on June 1, 2013. Businesses will have a 3 year period to phase in the requirements and if this has not been accomplished by the deadline in 2016 they will be required to cease their activities. This is another demonstration that China is working diligently to upgrade the quality of their pharmaceutical manufacture and distribution networks.
The guidance significantly increases the requirements for Quality Management. The relevant chapters include: General Provisions, Drug Wholesale Quality Management, Drug Retail Quality Management, and Supplementary provisions. Significant emphasis is placed on the standards to be implemented for computerized hardware and software systems. The use of controlled computerized systems is intended to both be an aid in protection of drug quality but will also serve as a barrier to entry into this part of the pharmaceutical business.
Regulatory Reform - Are we heading in the right direction?
The document summarizes updates from the Therapeutic Goods Administration (TGA) regarding regulatory reform efforts. Key points include: 1) TGA is restructuring to improve processes; 2) The government aims to improve innovation through regulatory reform while ensuring safety; and 3) TGA is working to streamline complementary medicine processes, international cooperation, manufacturing standards, and labelling reviews. The assistant secretary notes reforms are improving processes under the existing framework while further changes may come from ongoing reviews.
Pic guide liness seminar
The document provides an overview of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). It discusses the history and establishment of PIC/S as an extension of the Pharmaceutical Inspection Convention of 1970. PIC/S aims to lead the international development and harmonization of good manufacturing practice standards and quality systems for drug regulatory agencies. It operates through developing guidance documents, training inspectors, and facilitating cooperation between member authorities. The document outlines the process for countries and agencies to join PIC/S and lists many of PIC/S's recommendations and guidelines.
Who good distributionpracticesforpharmaceuticalproducts
The document summarizes the history and contents of the WHO Good Distribution Practices for Pharmaceutical Products guidelines. It was originally adopted in 2005 and revised in 2009 to improve security against counterfeit medicines. The goals are to ensure quality and identity of pharmaceuticals during distribution. It defines distribution and outlines general principles like traceability and responsibilities across the supply chain. Key points covered include regulations, personnel training, documentation, repackaging, recalls, investigating counterfeits, and next steps to finalize the guidelines.
Recommended
report 2015
Student received exam results for 12 modules taken in their Qualification program in Pharmacy. They received Distinctions for 5 modules, with marks ranging from 79-80, and Passed grades for 7 modules, with marks ranging from 68-75. Overall the student performed well, with above average marks in most modules.
9 150928065812-lva1-app6892 gmp
This document discusses Good Manufacturing Practices (GMP) for pharmaceuticals. It introduces GMP, explaining that GMP ensures pharmaceutical products are consistently manufactured and controlled to quality standards for their intended use. It also discusses the relationships between quality assurance (QA), GMP, and quality control (QC), noting that QA oversees the whole system, GMP ensures consistent manufacturing quality, and QC tests samples to ensure quality. Finally, it provides an overview of key aspects of GMP, including facilities, equipment, packaging, and documentation.
Hệ thống chất lượng dược phẩm GMP EU
Hệ thống chất lượng dược phẩm trong GMP EU. Xem thêm các tài liệu khác trên kênh của Công ty cổ phần Tư vấn Thiết kế GMP EU
Manufacturing Quality Branch – 2015 Achievements and Challenges
In 2015, the Manufacturing Quality Branch achieved improvements in GMP clearance times and inspection performance while also facing ongoing challenges. Key accomplishments included:
- Reducing median GMP clearance processing times from 18.8 weeks to 4.1 weeks through process improvements and increased communication.
- Completing 92% of domestic initial inspections and 94% of domestic reinspections within target timelines.
Looking ahead to 2016, plans include further streamlining the GMP clearance and inspection processes through application improvements, clearer sponsor expectations, and rewarding consistent compliance through less frequent inspections for high-performing facilities. The goal is more predictable timelines and reduced regulatory burden.
Gsp china
On January 22, 2013 the China SFDA published a Good Supply Practice guidance that will be implemented on June 1, 2013. Businesses will have a 3 year period to phase in the requirements and if this has not been accomplished by the deadline in 2016 they will be required to cease their activities. This is another demonstration that China is working diligently to upgrade the quality of their pharmaceutical manufacture and distribution networks.
The guidance significantly increases the requirements for Quality Management. The relevant chapters include: General Provisions, Drug Wholesale Quality Management, Drug Retail Quality Management, and Supplementary provisions. Significant emphasis is placed on the standards to be implemented for computerized hardware and software systems. The use of controlled computerized systems is intended to both be an aid in protection of drug quality but will also serve as a barrier to entry into this part of the pharmaceutical business.
Regulatory Reform - Are we heading in the right direction?
The document summarizes updates from the Therapeutic Goods Administration (TGA) regarding regulatory reform efforts. Key points include: 1) TGA is restructuring to improve processes; 2) The government aims to improve innovation through regulatory reform while ensuring safety; and 3) TGA is working to streamline complementary medicine processes, international cooperation, manufacturing standards, and labelling reviews. The assistant secretary notes reforms are improving processes under the existing framework while further changes may come from ongoing reviews.
Pic guide liness seminar
The document provides an overview of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). It discusses the history and establishment of PIC/S as an extension of the Pharmaceutical Inspection Convention of 1970. PIC/S aims to lead the international development and harmonization of good manufacturing practice standards and quality systems for drug regulatory agencies. It operates through developing guidance documents, training inspectors, and facilitating cooperation between member authorities. The document outlines the process for countries and agencies to join PIC/S and lists many of PIC/S's recommendations and guidelines.
Who good distributionpracticesforpharmaceuticalproducts
The document summarizes the history and contents of the WHO Good Distribution Practices for Pharmaceutical Products guidelines. It was originally adopted in 2005 and revised in 2009 to improve security against counterfeit medicines. The goals are to ensure quality and identity of pharmaceuticals during distribution. It defines distribution and outlines general principles like traceability and responsibilities across the supply chain. Key points covered include regulations, personnel training, documentation, repackaging, recalls, investigating counterfeits, and next steps to finalize the guidelines.
Report_2012-2015
This document contains exam results for a student for the period of 2012-2015. The student obtained a BEng in Chemical Engineering with a number of modules being passed with distinction. A total of 50 modules were completed with marks ranging from 0 to 86, with many modules receiving distinctions. Any modules with marks below 50 required a second attempt, from which passing marks were obtained.
Academic Transcripts
This document contains exam results for a student across multiple qualifications:
- For a BCom in Financial Accountancy, the student passed 17 modules between 2011-2013, achieving distinctions in 4 modules.
- For a BCom in Management Accountancy, the student passed all 5 modules in their results.
- For a BCom in Accountancy, the student's most recent results show they passed 13 modules since 2016, achieving distinctions in 6 modules.
GMP and cGMP Considerations Training by KLE University
GMP and cGMP considerations were discussed in the document. Some key points include:
- GMP refers to good manufacturing practices that help ensure products are consistently manufactured and controlled to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and current.
- Quality is defined as a product's fitness for purpose, where safety and efficacy are integral parts of quality.
- A basic tenet of GMP is that quality must be built into each batch during manufacturing rather than tested into the final product. This helps minimize risks that cannot be eliminated through final testing.
- GMP covers all aspects of production from facilities and equipment to staff training and hygiene. Detailed written procedures are essential.
Syllabus B.Pharm(Hons) Primeasia University MANIK
The document outlines the curriculum and syllabus for a 4-year Bachelor of Pharmacy (Honours) degree program. It includes details on course distribution, credit requirements, grading system, and course descriptions organized by year and semester. Over the 4 years, students take 154 credits of pharmacy core courses and ancillary courses, with coursework covering topics like pharmaceutical chemistry, pharmaceutics, pharmacology, and hospital/community pharmacy. The curriculum aims to provide students with the scientific knowledge and skills needed to work in the pharmaceutical industry, hospitals, and community pharmacies.
Academic Transcript 2013-2016
This document contains exam results for a student for two qualification programs - a BCom in Economics and International Trade from 2013-2016 and an Honours BCom in International Trade. For the BCom, the student passed 29 modules with distinctions in subjects like Financial Management, International Trade, and International Business Communication. For the Honours BCom, results are shown for 4 modules completed so far with distinctions in subjects like Export Market Development and International Trade Theory and Policy.
Syllabus B.Pharm 2008-09
This document outlines the syllabus for a Bachelor of Pharmacy (Honours) program at the University of Rajshahi in Bangladesh for the 2008-2009 academic year. It provides details on the program structure, course requirements, examinations and assessments over four years. The program is divided into four parts, with courses in subjects like inorganic chemistry, organic chemistry, pharmacology, and pharmaceutical technology. To graduate, students must complete 160 credits within 6 years, maintain minimum grade point averages for promotions and graduation, and pass all exams.
B pharm 08_09wm
This document outlines the syllabus for the B.Pharm program at the University of Rajshahi in Bangladesh from 2008-2009. It provides details on the course structure, distribution of marks, eligibility requirements and grading system over the four-year program. The B.Pharm consists of 160 credits spread across theoretical and practical courses in subjects like inorganic chemistry, organic chemistry, pharmacology, biochemistry and pharmaceutical technology. Students must maintain minimum attendance and grades to be eligible for promotion and graduation with the B.Pharm degree.
D pharm syllabus
This document outlines the syllabus, scheme, and regulations for a two-year Diploma in Pharmacy program. Some key details include:
- The duration of the course is two academic years with at least 180 working days per year plus 500 hours of practical training over 3 months.
- To be admitted, candidates must have passed science subjects at the intermediate level or equivalent exam. Admission is based on a pre-pharmacy test.
- To appear for exams, candidates must have attended at least 75% of classes. Some attendance relaxation may be granted.
- The course includes subjects like Pharmaceutics, Pharmaceutical Chemistry, Pharmacognosy, and more. Exams include theory and
Fdf98 1
This document describes the National Food Industry Training Council (NFITC) training framework and the components of the Food Processing Industry Training Package (FDF98).
The Training Package covers various food processing industries and sectors, including aerated waters, biscuits, confectionery, dairy processing, edible oils and fats, flour milling, fruit and vegetable, general foods, pastry, pet food, pharmaceutical manufacturing, plant baking, poultry, retail baking, stockfeed milling and tea and coffee.
The framework includes competency standards, assessment guidelines, learning/assessment strategies and resources, and national qualifications aligned to the Australian Qualifications Framework. A Training Package has two components - the nationally endorsed components
GOOD LABORATORY PRACTICE - GLPMA EXPECTATIOS FOR AUDIT OF THE QUALITY ASSURAN...
The document provides guidance for test facility management on conducting internal reviews or audits of their quality assurance programs annually to ensure compliance with Good Laboratory Practice principles. It recommends verifying aspects of the quality assurance program such as having sufficient qualified personnel, conducting inspections according to plans, addressing deviations, and complying with policies and procedures. The reviews should be done by independent staff to avoid conflicts of interest, though the regulatory agency will take a pragmatic view for small facilities.
G m p 01
GMP (Good Manufacturing Practices) are procedures and principles that help ensure pharmaceutical products are consistently produced and controlled according to quality standards appropriate for their intended use. A key principle of GMP is that quality must be built into every step of the manufacturing process rather than tested into the final product. GMP guidelines cover all aspects of production from facilities and equipment to staff training to ensure minimum risks like contamination, incorrect labeling, or insufficient active ingredients. Strict adherence to GMP procedures and documentation is important to ensure medicines are safe, effective and meet their intended purpose.
B.Pharma.pdf
This document outlines the rules and syllabus for the Bachelor of Pharmacy (B.Pharm) course as framed by the Pharmacy Council of India. It details the minimum qualifications for admission, duration of the program, medium of instruction, attendance requirements, credit structure, and course of study over 8 semesters. The program consists of theory and practical courses in subjects like Human Anatomy, Pharmaceutical Analysis, Pharmaceutics, Medicinal Chemistry, Pharmacology, and Industrial Pharmacy. Lateral entry students can join in the 3rd semester after completing a Diploma in Pharmacy.
quality by design
This document is a presentation on Quality by Design (QbD) in the pharmaceutical industry. It begins with an introduction comparing the traditional Quality by Test (QbT) approach to QbD. The presentation defines QbD and discusses ICH guidelines on QbD. It identifies key elements of QbD including Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters. The presentation outlines the steps for QbD implementation and importance of QbD in ensuring product quality and facilitating innovation.
ISO 29001 Lead Implementer - Two Page Brochure
MASTERING THE IMPLEMENTATION AND MANAGEMENT OF QUALITY MANAGEMENT SYSTEM
OF PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES, SECTOR-SPECIFIC FOR
PRODUCT AND SERVICE SUPPLY ORGANIZATIONS BASED ON ISO/TS 29001
New EU Requirements for Qualification & Validation
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Syllabus_B_Pharm for b pharm student studing under Rajiv Gandhi University o...
This document outlines revised regulations for the Bachelor of Pharmacy (B.Pharm.) degree program as established by the Pharmacy Council of India. Some key points:
- The program is divided into 8 semesters over 4 years for regular students and 6 semesters over 3 years for lateral entry students.
- Courses include subjects like Human Anatomy, Pharmaceutics, Medicinal Chemistry, Pharmacology, and Industrial Pharmacy.
- Minimum credit requirements, course structures, and syllabi are prescribed for each semester.
- Assessment includes continuous internal assessments and end-of-semester exams administered by the university.
- Admission criteria and eligibility, program committees, attendance policies,
AcademiceRecord-16178621-16_Dec_2015
This academic eRecord summarizes the course results for Andrew Robert Tilley, student number 16178621, who completed a Bachelor of Science in Food Science and Technology. It lists the courses taken semester by semester from 2013 to 2015, including course codes, titles, credits, grades, and marks. His overall weighted average was 83.10, placing him in good academic standing. The record notes that it reflects the university's student records system and that an official academic transcript must be obtained from Student Central.
Citac eurachem guide analytical chemistry
This document provides guidance for laboratories on quality assurance best practices for analytical chemistry operations. It was prepared jointly by CITAC and EURACHEM, building on previous guidance documents. The guidance aims to help laboratories implement quality systems and address the requirements of the ISO/IEC 17025 standard for testing and calibration laboratories. It focuses on technical quality assurance issues and provides interpretations for chemical testing measurements.
Syllabus_B_Pharm.pdf
The document outlines regulations for the Bachelor of Pharmacy (B. Pharm) degree program in India. It details admission requirements, duration of study, course structure, credits required, and assessment guidelines. The program is a 4-year/8-semester program for regular students and 3-year/6-semester program for lateral entry students. The curriculum includes theory and practical courses in subjects like Pharmaceutics, Pharmacology, Medicinal Chemistry etc. Students must earn a minimum of 208 credits to graduate, which are distributed across courses and other activities over the 8 semesters. Assessment includes continuous internal assessments and end-semester examinations.
Syllabus b pharm
The document outlines regulations for the Bachelor of Pharmacy (B. Pharm) degree program in India. It details admission requirements, duration of study, course structure, credits required, and assessment guidelines. The program is a 4-year/8-semester program for regular students and 3-year/6-semester program for lateral entry students. The curriculum includes theory and practical courses in subjects like Pharmaceutics, Pharmacology, Medicinal Chemistry etc. Students must earn a minimum of 208 credits to graduate, which are distributed across courses and other activities over the 8 semesters. Assessment includes continuous internal evaluation and end-semester examinations.
Curriculum Vitae- Leandri (1)
This curriculum vitae provides information on Leandri du Plessis, including her contact details, education history, hobbies and interests, sports involvement, cultural and leadership experience, and references. She has a B.Pharm degree from North West University and will be registered as an academic intern by March 2016. She is currently pursuing a Master's degree in Pharmaceutical Chemistry and has received multiple awards for academic excellence.
Recomondation letter 2
Leandrie has served Resonate Church faithfully since 2015, taking responsibility and completing every task with excellence. As a young and growing church with limited resources, Leandrie made the most of opportunities and is a natural leader who plans well and encourages others. The pastor believes Leandrie will accomplish great things in life as she faithfully serves her vision. He recommends her without hesitation for passionately and faithfully completing any task.
More Related Content
Similar to report 2014
Report_2012-2015
This document contains exam results for a student for the period of 2012-2015. The student obtained a BEng in Chemical Engineering with a number of modules being passed with distinction. A total of 50 modules were completed with marks ranging from 0 to 86, with many modules receiving distinctions. Any modules with marks below 50 required a second attempt, from which passing marks were obtained.
Academic Transcripts
This document contains exam results for a student across multiple qualifications:
- For a BCom in Financial Accountancy, the student passed 17 modules between 2011-2013, achieving distinctions in 4 modules.
- For a BCom in Management Accountancy, the student passed all 5 modules in their results.
- For a BCom in Accountancy, the student's most recent results show they passed 13 modules since 2016, achieving distinctions in 6 modules.
GMP and cGMP Considerations Training by KLE University
GMP and cGMP considerations were discussed in the document. Some key points include:
- GMP refers to good manufacturing practices that help ensure products are consistently manufactured and controlled to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and current.
- Quality is defined as a product's fitness for purpose, where safety and efficacy are integral parts of quality.
- A basic tenet of GMP is that quality must be built into each batch during manufacturing rather than tested into the final product. This helps minimize risks that cannot be eliminated through final testing.
- GMP covers all aspects of production from facilities and equipment to staff training and hygiene. Detailed written procedures are essential.
Syllabus B.Pharm(Hons) Primeasia University MANIK
The document outlines the curriculum and syllabus for a 4-year Bachelor of Pharmacy (Honours) degree program. It includes details on course distribution, credit requirements, grading system, and course descriptions organized by year and semester. Over the 4 years, students take 154 credits of pharmacy core courses and ancillary courses, with coursework covering topics like pharmaceutical chemistry, pharmaceutics, pharmacology, and hospital/community pharmacy. The curriculum aims to provide students with the scientific knowledge and skills needed to work in the pharmaceutical industry, hospitals, and community pharmacies.
Academic Transcript 2013-2016
This document contains exam results for a student for two qualification programs - a BCom in Economics and International Trade from 2013-2016 and an Honours BCom in International Trade. For the BCom, the student passed 29 modules with distinctions in subjects like Financial Management, International Trade, and International Business Communication. For the Honours BCom, results are shown for 4 modules completed so far with distinctions in subjects like Export Market Development and International Trade Theory and Policy.
Syllabus B.Pharm 2008-09
This document outlines the syllabus for a Bachelor of Pharmacy (Honours) program at the University of Rajshahi in Bangladesh for the 2008-2009 academic year. It provides details on the program structure, course requirements, examinations and assessments over four years. The program is divided into four parts, with courses in subjects like inorganic chemistry, organic chemistry, pharmacology, and pharmaceutical technology. To graduate, students must complete 160 credits within 6 years, maintain minimum grade point averages for promotions and graduation, and pass all exams.
B pharm 08_09wm
This document outlines the syllabus for the B.Pharm program at the University of Rajshahi in Bangladesh from 2008-2009. It provides details on the course structure, distribution of marks, eligibility requirements and grading system over the four-year program. The B.Pharm consists of 160 credits spread across theoretical and practical courses in subjects like inorganic chemistry, organic chemistry, pharmacology, biochemistry and pharmaceutical technology. Students must maintain minimum attendance and grades to be eligible for promotion and graduation with the B.Pharm degree.
D pharm syllabus
This document outlines the syllabus, scheme, and regulations for a two-year Diploma in Pharmacy program. Some key details include:
- The duration of the course is two academic years with at least 180 working days per year plus 500 hours of practical training over 3 months.
- To be admitted, candidates must have passed science subjects at the intermediate level or equivalent exam. Admission is based on a pre-pharmacy test.
- To appear for exams, candidates must have attended at least 75% of classes. Some attendance relaxation may be granted.
- The course includes subjects like Pharmaceutics, Pharmaceutical Chemistry, Pharmacognosy, and more. Exams include theory and
Fdf98 1
This document describes the National Food Industry Training Council (NFITC) training framework and the components of the Food Processing Industry Training Package (FDF98).
The Training Package covers various food processing industries and sectors, including aerated waters, biscuits, confectionery, dairy processing, edible oils and fats, flour milling, fruit and vegetable, general foods, pastry, pet food, pharmaceutical manufacturing, plant baking, poultry, retail baking, stockfeed milling and tea and coffee.
The framework includes competency standards, assessment guidelines, learning/assessment strategies and resources, and national qualifications aligned to the Australian Qualifications Framework. A Training Package has two components - the nationally endorsed components
GOOD LABORATORY PRACTICE - GLPMA EXPECTATIOS FOR AUDIT OF THE QUALITY ASSURAN...
The document provides guidance for test facility management on conducting internal reviews or audits of their quality assurance programs annually to ensure compliance with Good Laboratory Practice principles. It recommends verifying aspects of the quality assurance program such as having sufficient qualified personnel, conducting inspections according to plans, addressing deviations, and complying with policies and procedures. The reviews should be done by independent staff to avoid conflicts of interest, though the regulatory agency will take a pragmatic view for small facilities.
G m p 01
GMP (Good Manufacturing Practices) are procedures and principles that help ensure pharmaceutical products are consistently produced and controlled according to quality standards appropriate for their intended use. A key principle of GMP is that quality must be built into every step of the manufacturing process rather than tested into the final product. GMP guidelines cover all aspects of production from facilities and equipment to staff training to ensure minimum risks like contamination, incorrect labeling, or insufficient active ingredients. Strict adherence to GMP procedures and documentation is important to ensure medicines are safe, effective and meet their intended purpose.
B.Pharma.pdf
This document outlines the rules and syllabus for the Bachelor of Pharmacy (B.Pharm) course as framed by the Pharmacy Council of India. It details the minimum qualifications for admission, duration of the program, medium of instruction, attendance requirements, credit structure, and course of study over 8 semesters. The program consists of theory and practical courses in subjects like Human Anatomy, Pharmaceutical Analysis, Pharmaceutics, Medicinal Chemistry, Pharmacology, and Industrial Pharmacy. Lateral entry students can join in the 3rd semester after completing a Diploma in Pharmacy.
quality by design
This document is a presentation on Quality by Design (QbD) in the pharmaceutical industry. It begins with an introduction comparing the traditional Quality by Test (QbT) approach to QbD. The presentation defines QbD and discusses ICH guidelines on QbD. It identifies key elements of QbD including Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameters. The presentation outlines the steps for QbD implementation and importance of QbD in ensuring product quality and facilitating innovation.
ISO 29001 Lead Implementer - Two Page Brochure
MASTERING THE IMPLEMENTATION AND MANAGEMENT OF QUALITY MANAGEMENT SYSTEM
OF PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES, SECTOR-SPECIFIC FOR
PRODUCT AND SERVICE SUPPLY ORGANIZATIONS BASED ON ISO/TS 29001
New EU Requirements for Qualification & Validation
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Syllabus_B_Pharm for b pharm student studing under Rajiv Gandhi University o...
This document outlines revised regulations for the Bachelor of Pharmacy (B.Pharm.) degree program as established by the Pharmacy Council of India. Some key points:
- The program is divided into 8 semesters over 4 years for regular students and 6 semesters over 3 years for lateral entry students.
- Courses include subjects like Human Anatomy, Pharmaceutics, Medicinal Chemistry, Pharmacology, and Industrial Pharmacy.
- Minimum credit requirements, course structures, and syllabi are prescribed for each semester.
- Assessment includes continuous internal assessments and end-of-semester exams administered by the university.
- Admission criteria and eligibility, program committees, attendance policies,
AcademiceRecord-16178621-16_Dec_2015
This academic eRecord summarizes the course results for Andrew Robert Tilley, student number 16178621, who completed a Bachelor of Science in Food Science and Technology. It lists the courses taken semester by semester from 2013 to 2015, including course codes, titles, credits, grades, and marks. His overall weighted average was 83.10, placing him in good academic standing. The record notes that it reflects the university's student records system and that an official academic transcript must be obtained from Student Central.
Citac eurachem guide analytical chemistry
This document provides guidance for laboratories on quality assurance best practices for analytical chemistry operations. It was prepared jointly by CITAC and EURACHEM, building on previous guidance documents. The guidance aims to help laboratories implement quality systems and address the requirements of the ISO/IEC 17025 standard for testing and calibration laboratories. It focuses on technical quality assurance issues and provides interpretations for chemical testing measurements.
Syllabus_B_Pharm.pdf
The document outlines regulations for the Bachelor of Pharmacy (B. Pharm) degree program in India. It details admission requirements, duration of study, course structure, credits required, and assessment guidelines. The program is a 4-year/8-semester program for regular students and 3-year/6-semester program for lateral entry students. The curriculum includes theory and practical courses in subjects like Pharmaceutics, Pharmacology, Medicinal Chemistry etc. Students must earn a minimum of 208 credits to graduate, which are distributed across courses and other activities over the 8 semesters. Assessment includes continuous internal assessments and end-semester examinations.
Syllabus b pharm
The document outlines regulations for the Bachelor of Pharmacy (B. Pharm) degree program in India. It details admission requirements, duration of study, course structure, credits required, and assessment guidelines. The program is a 4-year/8-semester program for regular students and 3-year/6-semester program for lateral entry students. The curriculum includes theory and practical courses in subjects like Pharmaceutics, Pharmacology, Medicinal Chemistry etc. Students must earn a minimum of 208 credits to graduate, which are distributed across courses and other activities over the 8 semesters. Assessment includes continuous internal evaluation and end-semester examinations.
Similar to report 2014 (20)
GMP and cGMP Considerations Training by KLE University
GMP and cGMP Considerations Training by KLE University
GOOD LABORATORY PRACTICE - GLPMA EXPECTATIOS FOR AUDIT OF THE QUALITY ASSURAN...
GOOD LABORATORY PRACTICE - GLPMA EXPECTATIOS FOR AUDIT OF THE QUALITY ASSURAN...
New EU Requirements for Qualification & Validation
New EU Requirements for Qualification & Validation
Syllabus_B_Pharm for b pharm student studing under Rajiv Gandhi University o...
Syllabus_B_Pharm for b pharm student studing under Rajiv Gandhi University o...
More from Leandri du Plessis
Curriculum Vitae- Leandri (1)
This curriculum vitae provides information on Leandri du Plessis, including her contact details, education history, hobbies and interests, sports involvement, cultural and leadership experience, and references. She has a B.Pharm degree from North West University and will be registered as an academic intern by March 2016. She is currently pursuing a Master's degree in Pharmaceutical Chemistry and has received multiple awards for academic excellence.
Recomondation letter 2
Leandrie has served Resonate Church faithfully since 2015, taking responsibility and completing every task with excellence. As a young and growing church with limited resources, Leandrie made the most of opportunities and is a natural leader who plans well and encourages others. The pastor believes Leandrie will accomplish great things in life as she faithfully serves her vision. He recommends her without hesitation for passionately and faithfully completing any task.
Recomondation letter 1
Leandri duPlessis worked as a pharmacy assistant at Dis-Chem Vaal Mall from December 2013 to the present to help dispense medications and assist customers. Her manager, Jonet vander Westhuizen, writes that Leandri was conscientious about timekeeping and work quality, always pleasant and professional with clients and staff. The manager found that Leandri was quick to learn new skills and open to feedback, and would hire her again or recommend her for similar positions in the future.
More from Leandri du Plessis (7)
report 2014
- 1. Exam results for Student Student Records 1Page 2015/11/24 11:28:20 : 2014/01/01 - 2014/12/31: 23480599 - 2012 DU PLESSIS, L MISSUniversity Number Period Qualification program : 800 101 B PHARM Result : Modules Part Mark Exam Mark Mod Mark Result FCHG 3 11 PHARMACEUTICAL CHEMISTRY *** *** 75.0 Distinction FCHG 3 21 PHARMACEUTICAL CHEMISTRY *** *** 85.0 Distinction FGPO 3 71 STRUCTURED PRACTICAL TRAINING II *** *** 95.0 Distinction FKLG 3 11 PHARMACOLOGY III *** *** 65.0 Passed FKLG 3 21 PHARMACOLOGY IV *** *** 82.0 Distinction FMSG 3 11 PHARMACEUTICS *** *** 58.0 Passed FMSG 3 21 PHARMACEUTICAL DOSAGE FORMS AND TECHN II *** *** 78.0 Distinction FPFG 3 11 PHARMACEUTICAL AND THERAPEUTIC CARE *** *** 68.0 Passed FPFG 3 21 PHARMACEUTICAL AND THERAPEUTIC CARE *** *** 79.0 Distinction FPKG 3 12 PHARMACY PRACTICE II *** *** 88.0 Distinction FPKG 3 23 PHARMACY PRACTICE III *** *** 75.0 Distinction Number of Modules : 11 ***END OF REPORT***