Based on the Laboratory Analyst Training and Certification Program ... chemists from a range of pharmaceutical companies and a few academic laboratories explain how to comply with the US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly .... Among the topics are the drug development process, uniform and consistent interpretation of compliance issues, the role of statistics and basic topics in analytical chemistry, and detectors and quantitative analysis. The emphasis is on high-performance liquid chromatographic methods.

Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential elements such as , SOP’s, regulatory guidance’s/guidelines, project teams, technical and department processes, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including start-up, virtual, and generic pharmaceutical companies. ​

Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System. Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices. Additionally, a chapter outlining Stability Program operations is included in the text. In addition to these topics, it includes LCS information and tools such as: ● End of chapter templates, checklists, and LCS guidance to help you follow the required standards ● Electronic versions of each tool so users can use them outside of the text ● An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.

The 7th Edition of Gary Christian's Analytical Chemistry focuses on more in-depth coverage and information about Quantitative Analysis (aka Analytical Chemistry) and related fields. The content builds upon previous editions with more enhanced content that deals with principles and techniques of quantitative analysis with more examples of analytical techniques drawn from areas such as clinical chemistry, life sciences, air and water pollution, and industrial analyses.

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.

This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories.No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

In analytical chemistry and pharmaceutical technology attention is increasingly focussed on improving the quality of methods and products. This book aims at fostering the awareness of the potential of existing mathematical and statistical methods to improve this quality. It provides procedures and ideas on how to make a product or a method less sensitive to small variations in influencing factors. Major issues covered are robustness and stability improvement and ruggedness testing. General strategies and a theoretical introduction to these methods are described, and thorough overviews of methods used in both application areas and descriptions of practical applications are given.Features of this book:• Gives a good overview of mathematical and statistical methods used in two application areas, i.e. pharmaceutical technology and analytical chemistry• Illustrates the different approaches available to attain robustness• Gives ideas on how to use methods in practical situations.The book is intended for those who develop and optimize, and are responsible for the overall quality of, analytical methods and pharmaceutical technological products and procedures.

A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.

This new edition of a successful, bestselling book continues to provide you with practical information on the use of statistical methods for solving real-world problems in complex industrial environments. Complete with examples from the chemical and pharmaceutical laboratory and manufacturing areas, this thoroughly updated book clearly demonstrates how to obtain reliable results by choosing the most appropriate experimental design and data evaluation methods. Unlike other books on the subject, Statistical Methods in Analytical Chemistry, Second Edition presents and solves problems in the context of a comprehensive decision-making process under GMP rules: Would you recommend the destruction of a $100,000 batch of product if one of four repeat determinations barely fails the specification limit? How would you prevent this from happening in the first place? Are you sure the calculator you are using is telling the truth? To help you control these situations, the new edition: * Covers univariate, bivariate, and multivariate data * Features case studies from the pharmaceutical and chemical industries demonstrating typical problems analysts encounter and the techniques used to solve them * Offers information on ancillary techniques, including a short introduction to optimization, exploratory data analysis, smoothing and computer simulation, and recapitulation of error propagation * Boasts numerous Excel files and compiled Visual Basic programs-no statistical table lookups required! * Uses Monte Carlo simulation to illustrate the variability inherent in statistically indistinguishable data sets Statistical Methods in Analytical Chemistry, Second Edition is an excellent, one-of-a-kind resource for laboratory scientists and engineers and project managers who need to assess data reliability; QC staff, regulators, and customers who want to frame realistic requirements and specifications; as well as educators looking for real-life experiments and advanced students in chemistry and pharmaceutical science. From the reviews of Statistical Methods in Analytical Chemistry, First Edition: "This book is extremely valuable. The authors supply many very useful programs along with their source code. Thus, the user can check the authenticity of the result and gain a greater understanding of the algorithm from the code. It should be on the bookshelf of every analytical chemist."-Applied Spectroscopy "The authors have compiled an interesting collection of data to illustrate the application of statistical methods . . . including calibrating, setting detection limits, analyzing ANOVA data, analyzing stability data, and determining the influence of error propagation."-Clinical Chemistry "The examples are taken from a chemical/pharmaceutical environment, but serve as convenient vehicles for the discussion of when to use which test, and how to make sense out of the results. While practical use of statistics is the major concern, it is put into perspective, and the reader is urged to use plausibility checks."-Journal of Chemical Education "The discussion of univariate statistical tests is one of the more thorough I have seen in this type of book . . . The treatment of linear regression is also thorough, and a complete set of equations for uncertainty in the results is presented . . . The bibliography is extensive and will serve as a valuable resource for those seeking more information on virtually any topic covered in the book."-Journal of American Chemical Society "This book treats the application of statistics to analytical chemistry in a very practical manner. [It] integrates PC computing power, testing programs, and analytical know-how in the context of good manufacturing practice/good laboratory practice (GMP/GLP) . . .The book is of value in many fields of analytical chemistry and should be available in all relevant libraries."-Chemometrics and Intelligent Laboratory Systems