Author: Barnard S. ProctorPublisher:
ISBN:
Category :
Languages : en
Pages : 208
Book Description
A Manual of Pharmaceutical Testing for the Man of Business and His Assistants
Author: Barnard S. ProctorA Manual of Pharmacuetical Testing for the Man of Business and His Assistants
Author: Barnard Simpson ProctorPublisher:
ISBN:
Category : Analytical chemistry
Languages : en
Pages : 212
Book Description
A Manual of Pharmaceutical Testing for the Man of Business and His Assistants
Author: Barnard Simpson ProctorPublisher: Forgotten Books
ISBN: 9780332357379
Category : Science
Languages : en
Pages : 200
Book Description
Excerpt from A Manual of Pharmaceutical Testing for the Man of Business and His Assistants: Comprising Simple Instructions for the Testing of the Chemicals of the British Pharmacopoeia Etc. With Such Materials and Appliances as Are in Common Use at the Dispensing Counter It is hoped that this brief and imperfect handbook will encourage the habit of testing the Chemicals used in medicine. About the Publisher Forgotten Books publishes hundreds of thousands of rare and classic books. Find more at www.forgottenbooks.com This book is a reproduction of an important historical work. Forgotten Books uses state-of-the-art technology to digitally reconstruct the work, preserving the original format whilst repairing imperfections present in the aged copy. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in our edition. We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the state of such historical works.
Pharmaceutical Microbiology Manual
Author: United States Food and Drug AdministrationPublisher: Createspace Independent Publishing Platform
ISBN: 9781976578670
Category :
Languages : en
Pages : 92
Book Description
Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.
A Manual of Pharmaceutical Testing
Author: Barnard Simpson ProctorPublisher:
ISBN:
Category :
Languages : en
Pages : 188
Book Description
Analytical Testing for the Pharmaceutical GMP Laboratory
Author: Kim Huynh-BaPublisher: John Wiley & Sons
ISBN: 1119120918
Category : Science
Languages : en
Pages : 420
Book Description
Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.
Pharmaceutical Chemical Analysis
Author: Ole PedersenPublisher: CRC Press
ISBN: 0203492269
Category : Medical
Languages : en
Pages : 168
Book Description
Complete, referenced information in an easy-to-use formatMany of the monographs in the European Pharmacopiea, the industry standard test for certain groups of ingredients and excipients, do not describe the tests in full, but reference general methods based on test-tube chemistry. When a test fails, you need to know what went wrong, how it can be f
Quality Control Training Manual
Author: Syed Imtiaz HaiderPublisher: CRC Press
ISBN: 143985016X
Category : Medical
Languages : en
Pages : 484
Book Description
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Laboratory Manual of Pharmaceutical Inorganic Chemistry
Author: Dr. Prashant D. Aragade Publisher: Trinity Publishing House, Satara
ISBN: 8196569467
Category : Medical
Languages : en
Pages : 104
Book Description
We are pleased to present the "Laboratory Manual of Pharmaceutical Inorganic Chemistry". This manual is prepared according to the PCI B. Pharm course regulations 2014 and is divided into four sections: limit tests, identification tests, purity tests, and preparation of inorganic pharmaceuticals. The methods of all the experiments are taken from the latest editions of official books such as the Indian, European, British and US Pharmacopoeia, and research papers, so that the latest advancements in the methods or apparatus can be incorporated. The purpose of pharmaceutical inorganic chemistry practicals is to provide students with hands-on experience in understanding and applying the principles of inorganic chemistry to pharmaceutical applications. Through these practical sessions, students can learn how to prepare, analyze, and characterize inorganic pharmaceutical compounds, which are important in drug development, formulations, and quality control processes. These practicals also help students gain essential laboratory skills, such as safely handling chemicals and using various analytical techniques, which are crucial for their future careers in the pharmaceutical industry or research. This manual is designed for outcome-based education and each experiment is arranged in a uniform way, with sections for practical significance, practical outcomes (PrOs), mapping with course outcomes, theory, resources used, procedure, precautions, observations, results, conclusion, references, and synopsis questions. Each experiment offers an opportunity for students to perform practical work, allowing them to gain proficiency in effectively managing equipments, handling glasswares, chemicals and reagents, and writing reports. In addition, the questions at the end of the experiments help to enhance students' knowledge, which will be beneficial for them as they pursue higher studies. We acknowledge the help and cooperation of various persons in bringing out this manual. We are highly indebted to the authors of the books and articles mentioned in the references, which were a major source of information for writing this manual. We also thank the publishers, designers, and printers who worked hard to publish this manual in a timely manner. We hope that this manual will be helpful to students in understanding concepts, principles, and procedures. We wish you all the best!
The Medical Review Officer's Manual
Author: Robert B. SwotinskyPublisher:
ISBN: 9781883595388
Category : Medical
Languages : en
Pages : 229
Book Description