10 Best Pharmaceutical Books of All Time
1. Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017
Orange Guide is must to have for an organization distributing pharmaceutical products in United Kingdom (UK). It is rules and guidance for pharmaceutical industry with an information on legislation relating to the manufacture and distribution of medicines for human use. This is the most recent Orange Book published by MHRA.
One cannot remember all the regulations and guidance but having book handy on the desk will be very helpful aid for day to day decisions and implementation of procedures.
2. How to Validate a Pharmaceutical Process (Expertise in Pharmaceutical Process Technology)
The book “How to Validate a Pharmaceutical Process” provides a how to approach to developing and implementing a sustainable pharmaceutical process validation program.
The book addresses practical issues and offers solutions to qualify and validate a pharmaceutical process.
The book covers current requirement of process performance qualification and essential topics of life-cycle approach, quality by design, risk assessment, critical process parameters as suggested by US, EU, WHO, and other regulatory bodies.
3. Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance
Regulatory bodies encourages pharmaceutical organization to use current technology and automation in order to improve robust process control, data management, data traceability and improve the data integrity. All the advanced systems are based on automation and computerized controls.
In this scenario, adequacy of computer system validation is very essential to ensure robustness of system and data integrity. The book provides comprehensive overview of computer validation and verification principles and how to put them into practice.
Key topics in this book includes:
Approach according to GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP (21 CFR Part 11)
ICH Guidance Q8, Q9, and Q10 expectations
PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
Practical guidance on handling common high, medium, and low risk issues
Managing outsource partners and handling legacy systems
4. Pharmaceutical Microbiology, Essentials for Quality Assurance and Quality Control
Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control covers current information on microbial contamination of pharmaceutical and healthcare products, and protecting patients from the microbial contamination. Prevention of microbial contamination is necessary for both, sterile and non-sterile products.
The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.
Contains the applications of pharmaceutical microbiology in sterile and non-sterile products
Presents the practical aspects of pharmaceutical microbiology testing
Provides contamination control risks and remediation strategies, along with rapid microbiological methods
Includes bioburden, endotoxin, and specific microbial risks
Highlights relevant case studies and risk assessment scenarios
5. Pharmaceutical Stability Testing to Support Global Markets (Biotechnology: Pharmaceutical Aspects Book 12)
The International Conference of Harmonization (ICH) has done extension work to harmionize the guidance on stability studies through a stability guideline Q1A (R2). Still, pharmaceutical community has continued to discuss to further improve requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world.
In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. The author of this book has worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. This book will be beneficial to pharmaceutical professionals in providing guidance and up-to-date information for building quality stability programs.
6. Bottle of Lies : Ranbaxy and the Dark Side of Indian Pharma
In 2004, Dinesh Thakur, a senior employee of Ranbaxy, then India’s largest pharma company, discovered a terrible secret.Ranbaxy had been fabricating the test results of their drugs,endangering millions of patients. Thakur resigned and became a whistleblower to the US Food and Drug Administration, one of the regulators Ranbaxy had been lying to, and ultimately brought the multibillion-dollar behemoth to its knees. This is the sensational account of the high-stakes chase to bring Ranbaxy to book and the fall from grace of one of corporate India’s biggest success stories. But the rot in Indian pharma isn’t confined to Ranbaxy alone.
In this book, investigative journalist Katherine Eban relies on over 20,000 FDA documents and interviews with over 240 people to show how fraud and trickery are deeply entrenched in much of the industry in India, and raises troubling questions about some of its biggest names – Wockhardt, Dr Reddy’s, Glenmark and RPG Life Sciences. Filled with shocking and eye-opening details, this book lays bare the ugly truth of Indian pharma. It will make you view every pill you take with foreboding and suspicion.
7. Current Practice of Gas Chromatography-Mass Spectrometry
This volume details the principles and instrumentation of gas chromatography-mass spectrometry (CG-MS)and outlines industrial, environmental, pharmaceutical, clinical, toxicological, forensic and food-related applications, revealing findings from the laboratories of 40 contributing scientists around the world using GC-MS in practice. It describes upstream and downstream applications of GC-MS in the petroleum industry and identifies chlorinated compounds in the environment with quadrupole ion-trap technology and high-resolution sector instruments.
This volume details the principles and instrumentation of gas chromatography-mass spectrometry (CG-MS)and outlines industrial, environmental, pharmaceutical, clinical, toxicological, forensic and food-related applications, revealing findings from the laboratories of 40 contributing scientists around the world using GC-MS in practice. It describes upstream and downstream applications of GC-MS in the petroleum industry and identifies chlorinated compounds in the environment with quadrupole ion-trap technology and high-resolution sector instruments.
8. Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (Statistics for Biology and Health)
This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry.
The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader.
The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry.
Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
9. Liquid Chromatography for the Analyst: 67 (Chromatographic Science Series)
This work provides a clear presentation of the chromatographic process – demonstrating the functions of all associated instrumentation and the procedures necessary to obtain accurate qualitative and quantitative results. The work supplies a host of applications from a variety of sources to help identify the best equipment, the most appropriate columns and the most suitable phase systems for specific samples.
10. Pharmaceutical Dosage Forms and Drug Delivery
Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems Master the intricacies of pharmaceutical design and production succeed in your course with Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems, the most comprehensive source on this subject available today Reflecting the CAPE, APhA and Naplex competencies, this trusted resource explores the interrelationships between pharmaceutical and biopharmaceutical principles, product design, formulation, manufacture, compounding and the clinical application of the various dosage forms in patient care, as well as regulations and standards governing the manufacturing and compounding of pharmaceuticals.
Key Features:
Discover the latest on dosage form design and formulation, good compounding practices,
quality assurance for pharmacy-prepared sterile products and much more with meticulous
updates from cover to cover.
n Learn about clinical pharmaceutics with a brand-new chapter on this important topic, as well as added content throughout.
See pharmaceutical concepts in action through the two case studies (one pharmaceutical and one clinical) in each chapter on dosing forms.
Practice what you learn using the group and individual activities in Applying the Principles and Concepts sections in every chapter.
Master important underlying pharmaceutical principles through Physical Pharmacy Capsules.
Study efficiently with Chapter Objectives and Chapter at a Glance sections that highlight the key material you need to master.
New addition to the appendix includes, review of active ingredient considerations in dosing.