This document discusses Good Manufacturing Practices (GMP) for the pharmaceutical industry. It begins by defining GMP and explaining why GMP is important for ensuring product quality and safety. The document then outlines some of the key principles of GMP, including having detailed written procedures and documentation for all processes. It also discusses quality management systems, distinguishing between quality control, quality assurance, and quality management. The document provides details on the components and purpose of a quality management manual. Finally, it covers some additional GMP topics like equipment requirements, production and process control, and packaging and labeling control.
This document discusses Good Manufacturing Practices (GMP) for the pharmaceutical industry. It begins by defining GMP and explaining why GMP is important for ensuring product quality and safety. The document then outlines some of the key principles of GMP, including having detailed written procedures and documentation for all processes. It also discusses quality management systems, distinguishing between quality control, quality assurance, and quality management. The document provides details on the components and purpose of a quality management manual. Finally, it covers some additional GMP topics like equipment requirements, production and process control, and packaging and labeling control.
This document discusses extractables and leachables (E&L) analysis for drug products. It defines leachables and extractables, provides examples, and outlines the risks. It describes forced extraction studies to identify potential extractables/leachables and determine safety thresholds. It discusses developing validated analytical methods, including leachables analysis in stability studies. The document emphasizes that careful E&L analysis is important to evaluate the safety of drug products.
This document summarizes recent amendments to the Drugs and Cosmetics Act from 2015 to 2017. It provides a brief history of the Act and describes amendments related to labeling requirements, clinical trial rules, licensing durations, and import regulations. Key points include:
- New labeling requirements in 2015-2016 for barcodes and scheduled drugs.
- 2017 rules define medical devices and exempt certain academic clinical trials.
- Licensing durations extended to every 5 years if retention fee is paid.
- Small donations to charitable hospitals can now be imported for free patient care.
21-CODE CODE OF FEDERAL REGULATIONS (CFR) surajkumar1499
The Code of Federal Regulations (CFR) is the codification of all general and permanent rules published in the Federal Register by executive branch agencies of the U.S. federal government. It is divided into 50 titles according to broad subject areas, which are further divided into chapters, parts, and sections. Title 21 governs food and drugs and is divided into 3 chapters covering the FDA, DEA, and ONDCP. The CFR provides regulations for areas like pharmaceuticals, medical devices, radiation-emitting devices, and tobacco. It also gives research tools like tables of contents and lists of affected sections to help navigate regulations.
This document provides an overview of the key drug laws in Pakistan, including the Drugs Act of 1976, rules framed under the Act, the DRAP Act of 2012, and the Pharmacy Act of 1967. It summarizes the purpose and some important sections of each law. The Drugs Act regulates drug import, manufacture, storage, distribution and sale. It establishes various regulatory bodies and sets penalties for violations. The rules framed under the Act cover licensing, registration, advertising and other areas. The DRAP Act established the Drugs Regulatory Authority of Pakistan and regulates biologicals, drugs, medical devices and other therapeutic goods. The Pharmacy Act established pharmacy councils and regulates the profession of pharmacy.
The importance of extractable/leachable testing in Pharmaceutical Dosage forms has grown considerably in the last few years.Recent USP general chapters <1663>, <1664> states the requirements for extractables and leachables in regulatory submissions. There were several criticalities associated in the container closure system assessment in identifying the probable leachables that could impact the
quality of the Drug product. Control extractions studies provide an insight based on the technical characteristics and logical conclusions made. Technology advancements and bundles of literature provided major insights in understanding the analytical evaluation limits,specifications and procedural things conducting extractable and leachable studies. This presentation provides a summary and overview of regulatory requirements for extractables and leachables with the current trend of FDA deficiencies for the drug products.
The document discusses in-process and finished product quality control tests for parenterals. It defines parenterals as sterile preparations intended for administration by injection, infusion, or implantation. It describes various types of parenterals including small volume parenterals like ampoules and vials, as well as large volume parenterals. The document then outlines several important in-process quality control tests that are conducted on parenterals to ensure safety, identity, strength, quality and purity. These include tests like content uniformity, leakage, sterility, bacterial endotoxins and clarity. Specific test methods, acceptance criteria and significance are provided for key tests according to compendial standards.
This document provides an introduction to extractables and leachables for pharmaceutical packaging. It defines extractables as compounds that can be extracted from packaging materials under aggressive extraction conditions, while leachables are those that migrate into drugs under normal conditions. The relationship between extractables, as the total potential pool of migrating compounds, and leachables, as the actual level that leaches into drugs, is explained. Key aspects of extractable and leachable screening covered include extraction/leaching conditions, regulatory guidelines, packaging material composition, and real examples of issues that have occurred.
This pharmaceutical development report describes the development of a generic modified release tablet to match the reference listed drug. A quality target product profile was established based on the properties of the active drug substance and reference listed drug characteristics. Critical quality attributes were identified, including physical attributes, assay, content uniformity and drug release. The generic tablet was designed to contain immediate release granules and extended release polymer-coated beads compressed into scored tablets. Formulation and manufacturing processes were optimized using a quality by design approach and design of experiments to ensure matching of the critical quality attributes of the reference listed drug.
Selection and evaluation of pharmaceutical packaging materials pdtt 2AMOGH DANDEKAR
This document discusses the selection and evaluation of pharmaceutical packaging materials. It describes the key characteristics packaging materials must have to protect pharmaceutical products, including being non-reactive and non-toxic. The main packaging materials discussed are glass, plastic, metal, and paper. Factors like the dosage form, route of administration, and stability of the product and packaging material are considered when selecting materials. Containers and closures are also described along with common material types used and ideal requirements. Evaluation tests for containers and closures are mentioned to ensure suitability for pharmaceutical use.
The document discusses guidelines for stability testing from the International Conference on Harmonisation (ICH). It provides an overview of several ICH guidelines related to stability testing of drug substances and products, including guidelines on photostability testing, new dosage forms, bracketing and matrixing designs, and evaluation of stability data. It also summarizes key aspects of conducting stability studies such as selecting representative batches, appropriate container closure systems, testing frequency and storage conditions, and evaluation of results. Stress testing is discussed as a way to validate analytical methods and identify potential degradants.
This document discusses extractables and leachables (E&L) analysis for drug products. It defines leachables and extractables, provides examples, and outlines the risks. It describes forced extraction studies to identify potential extractables/leachables and determine safety thresholds. It discusses developing validated analytical methods, including leachables analysis in stability studies. The document emphasizes that careful E&L analysis is important to evaluate the safety of drug products.
This document summarizes recent amendments to the Drugs and Cosmetics Act from 2015 to 2017. It provides a brief history of the Act and describes amendments related to labeling requirements, clinical trial rules, licensing durations, and import regulations. Key points include:
- New labeling requirements in 2015-2016 for barcodes and scheduled drugs.
- 2017 rules define medical devices and exempt certain academic clinical trials.
- Licensing durations extended to every 5 years if retention fee is paid.
- Small donations to charitable hospitals can now be imported for free patient care.
21-CODE CODE OF FEDERAL REGULATIONS (CFR) surajkumar1499
The Code of Federal Regulations (CFR) is the codification of all general and permanent rules published in the Federal Register by executive branch agencies of the U.S. federal government. It is divided into 50 titles according to broad subject areas, which are further divided into chapters, parts, and sections. Title 21 governs food and drugs and is divided into 3 chapters covering the FDA, DEA, and ONDCP. The CFR provides regulations for areas like pharmaceuticals, medical devices, radiation-emitting devices, and tobacco. It also gives research tools like tables of contents and lists of affected sections to help navigate regulations.
This document provides an overview of the key drug laws in Pakistan, including the Drugs Act of 1976, rules framed under the Act, the DRAP Act of 2012, and the Pharmacy Act of 1967. It summarizes the purpose and some important sections of each law. The Drugs Act regulates drug import, manufacture, storage, distribution and sale. It establishes various regulatory bodies and sets penalties for violations. The rules framed under the Act cover licensing, registration, advertising and other areas. The DRAP Act established the Drugs Regulatory Authority of Pakistan and regulates biologicals, drugs, medical devices and other therapeutic goods. The Pharmacy Act established pharmacy councils and regulates the profession of pharmacy.
The importance of extractable/leachable testing in Pharmaceutical Dosage forms has grown considerably in the last few years.Recent USP general chapters <1663>, <1664> states the requirements for extractables and leachables in regulatory submissions. There were several criticalities associated in the container closure system assessment in identifying the probable leachables that could impact the
quality of the Drug product. Control extractions studies provide an insight based on the technical characteristics and logical conclusions made. Technology advancements and bundles of literature provided major insights in understanding the analytical evaluation limits,specifications and procedural things conducting extractable and leachable studies. This presentation provides a summary and overview of regulatory requirements for extractables and leachables with the current trend of FDA deficiencies for the drug products.
The document discusses in-process and finished product quality control tests for parenterals. It defines parenterals as sterile preparations intended for administration by injection, infusion, or implantation. It describes various types of parenterals including small volume parenterals like ampoules and vials, as well as large volume parenterals. The document then outlines several important in-process quality control tests that are conducted on parenterals to ensure safety, identity, strength, quality and purity. These include tests like content uniformity, leakage, sterility, bacterial endotoxins and clarity. Specific test methods, acceptance criteria and significance are provided for key tests according to compendial standards.
This document provides an introduction to extractables and leachables for pharmaceutical packaging. It defines extractables as compounds that can be extracted from packaging materials under aggressive extraction conditions, while leachables are those that migrate into drugs under normal conditions. The relationship between extractables, as the total potential pool of migrating compounds, and leachables, as the actual level that leaches into drugs, is explained. Key aspects of extractable and leachable screening covered include extraction/leaching conditions, regulatory guidelines, packaging material composition, and real examples of issues that have occurred.
This pharmaceutical development report describes the development of a generic modified release tablet to match the reference listed drug. A quality target product profile was established based on the properties of the active drug substance and reference listed drug characteristics. Critical quality attributes were identified, including physical attributes, assay, content uniformity and drug release. The generic tablet was designed to contain immediate release granules and extended release polymer-coated beads compressed into scored tablets. Formulation and manufacturing processes were optimized using a quality by design approach and design of experiments to ensure matching of the critical quality attributes of the reference listed drug.
Selection and evaluation of pharmaceutical packaging materials pdtt 2AMOGH DANDEKAR
This document discusses the selection and evaluation of pharmaceutical packaging materials. It describes the key characteristics packaging materials must have to protect pharmaceutical products, including being non-reactive and non-toxic. The main packaging materials discussed are glass, plastic, metal, and paper. Factors like the dosage form, route of administration, and stability of the product and packaging material are considered when selecting materials. Containers and closures are also described along with common material types used and ideal requirements. Evaluation tests for containers and closures are mentioned to ensure suitability for pharmaceutical use.
The document discusses guidelines for stability testing from the International Conference on Harmonisation (ICH). It provides an overview of several ICH guidelines related to stability testing of drug substances and products, including guidelines on photostability testing, new dosage forms, bracketing and matrixing designs, and evaluation of stability data. It also summarizes key aspects of conducting stability studies such as selecting representative batches, appropriate container closure systems, testing frequency and storage conditions, and evaluation of results. Stress testing is discussed as a way to validate analytical methods and identify potential degradants.
This document provides the top 30 interview questions commonly asked of cabin crew applicants. The questions cover a range of topics including safety procedures, customer service skills, dealing with difficult passengers, and demonstrating flexibility and teamwork abilities. Prospective cabin crew should prepare examples from their background that highlight their ability to remain calm under pressure, resolve conflicts, and provide excellent customer service.
La pandemia de COVID-19 ha tenido un impacto significativo en la economía mundial. Muchos países experimentaron fuertes caídas en el PIB y aumentos en el desempleo debido a los cierres generalizados. Ahora, a medida que se levantan las restricciones, la recuperación económica será gradual a medida que los consumidores y las empresas se readaptan a la nueva normalidad.
แนวทางการจัดการความเสี่ยงที่ส่งผลต่อต้นทุนการจัดการสินค้าคงคลัง
ของร้านขายยา CDE ในจังหวัดขอนแก่น
The Approach of Risk Management that Affecting the
Inventory Management Cost of CDE Drugstore in Khonkaen Province
Best Practice in Communication
ราชวิทยาลัยกุมารแพทย์แห่งประเทศไทย สมาคมกุมารแพทย์แห่งประเทศไทย
บรรณาธิการ วินัดดา ปิยะศิลป์ วันดี นิงสานนท์
ISBN 978-616-91972-1-8
Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoeaUtai Sukviwatsirikul
This systematic review and meta-analysis evaluated the effectiveness of Saccharomyces boulardii in preventing antibiotic-associated diarrhea in children and adults based on 21 randomized controlled trials involving 4780 participants. The administration of S. boulardii compared to placebo or no treatment reduced the risk of antibiotic-associated diarrhea from 18.7% to 8.5%. S. boulardii was effective in reducing the risk of antibiotic-associated diarrhea in both children and adults. It also reduced the risk of Clostridium difficile-associated diarrhea in children but not adults. Overall, the results confirm that S. boulardii is effective for preventing antibiotic-associated diarrhea in children and adults.
This document provides information on drugs used to treat acute diarrhea. It begins with definitions of diarrhea from WHO. It then discusses estimates of child mortality due to diarrhea in Thailand from 2010 to 2012. It presents data on the age distribution of diarrhea cases and hospital admissions. It lists common bacterial, viral, and parasitic pathogens that cause childhood diarrhea. It discusses the pathogenesis of acute diarrhea and describes fluid and electrolyte losses and consequences of dehydration and nutritional deficits. It provides details on fluid and electrolyte composition of diarrheal stool from different pathogens. It outlines the objectives of diarrhea treatment and causes of death. It then discusses use of oral rehydration therapy and solutions. It recommends probiotics, continued feeding, and zinc supplementation. It
Systematic review with meta-analysis: Saccharomyces boulardii in the preventi...Utai Sukviwatsirikul
This systematic review and meta-analysis evaluated the effectiveness of Saccharomyces boulardii in preventing antibiotic-associated diarrhea in children and adults based on 21 randomized controlled trials involving 4780 participants. The administration of S. boulardii compared to placebo or no treatment reduced the risk of antibiotic-associated diarrhea from 18.7% to 8.5%. S. boulardii was effective in reducing the risk of antibiotic-associated diarrhea in both children and adults. It also reduced the risk of Clostridium difficile-associated diarrhea in children. The quality of evidence was rated as moderate to low based on limitations in the design and reporting of the included studies. This meta-analysis confirms the effectiveness of
Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea ...Utai Sukviwatsirikul
Saccharomyces boulardii in the prevention of antibiotic-associated
diarrhoea in children: a randomized double-blind placebo-controlled
trial
M. KOTOWSKA, P. ALBRECHT & H. SZAJEWSKA
Department of Pediatric Gastroenterology and Nutrition, The Medical University of Warsaw, Warsaw, Poland
Accepted for publication 24 November 2004