STANDARDS

New Drug Approval Process: The Global Challenge

"This text [is] a useful road map to understanding the requirements that a drug product must fulfill to achieve approval." -- Journal of Medicinal Chemistry

"…very valuable…

"…should be a required reading….highly recommended." -- Guarino

"…very valuable… "…should be a required reading for anyone entering the strait-jacket world of modern pharmaceutical development….highly recommended. -- Pharmaceutical Development and Technology

Oxford Pharmaceutical Resources, Inc., Totowa, NJ. Covers the new emphasis on over-the-counter drugs, latest techniques of institutional review boards, Good Clinical Practice standards set by the FDA, adverse drug reaction standards, and more. For professionals in pharmaceutical industry.

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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 2 - Regulations, Standards, and Guidelines)

Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I. The book is presented in an convenient, easy-to-read format, organized to provide fast access to the guidelines and regulations of interest.

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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis)

Volume 1 of this three-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format.

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The Japanese Pharmacopoeia Fifteenth Edition (JP XV)

This is the English version of the 15th edition of the "Japanese Pharmacopoeia". It provides the official Japanese standard for the description and quality of drug substances and products. It contains over 1,300 articles regarding: general rules for preparations; processes and apparatus; monographs on drugs; and infrared reference spectra and ultraviolet-visible reference spectra.

Official Monographs provides 1483 articles, including 102 articles newly added and 8 articles deleted. Comprises the following items in order: The Ministry of Health, Labour and Welfare Ministerial Notification; Contents; Preface; General Notices; General Rules for Crude Drugs; General Rules for Preparations; General Tests, Processes and Apparatus; Official Monographs, including Monographs for Crude Drugs; Infrared Reference Spectra; Ultraviolet-visual Reference Spectra; General Information; Atomic Weight Table (2004) and Standard Atomic Weights 2004 as Appendix ; and Cumulative Index (English, Latin and Japanese titles).

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Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

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Guidelines for the Import and Export of Drug and Precursor Reference Standards for use by National Drug Testing Laboratories and Competent National Au

These guidelines have been published to assist national laboratories and other relevant scientific institutions in obtaining, in a timely fashion, the reference standards that they require. They address some of the most frequently encountered difficulties.

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A Pharmacology Primer, Third Edition: Theory, Application and Methods

This successful guide assists scientists trained in molecular biology and related fields who now need to know the basic theories, principles and practical applications of pharmacology. This latest edition continues the tradition of better preparing researchers in the basics of pharmacology. With expanded hands-on exercises and the addition of Pharmacokinetics coverage, new human interest material including historical facts in pharmacology and a new section on therapeutics that will help readers identify with diseases and drug treatments.

The ideal book for researchers in drug discovery who have seen their role shift from "individual" to "team player" where that team includes chemists, biologists, and others with strong, but varied, science backgrounds who must now work together toward their common pharmacology goal.

At GlaxoSmithKline, a pharmaceuticals world-leader, Terry Kenakin regularly teaches a course for their research scientists and has drawn on his experience to create a pharmacology primer.

*New - Latest coverage of the chemistry of drugs including expanded coverage of the pharmacokinetic discussion of druglike properties -- Increases reader understanding of necessary ADME (Absorption, Distribution, Metabolism, and Excretion) properties and increases the rate of drug approval and acceptance.

*Context - Unique discussions on various drug discovery teams and the role of the chemist on those teams -- Promotes the understanding of these expanding roles and responsibilities and how to maximize the effective contributions of each matrix team member.

*Real-world learning - There are hands-on exercises, with extensive answers, utilizing real data on structure activity relationships; utilization of pharmacological principles to make general statements about how changes in structure lead to changes in drug activity. + hands on exercises with extensive answers on Pharmacokinetics -- Stengthens practical application and understanding of core concepts and principles.

*Study sections are organized with ASPET (American Society for Pharmacology and Experimental Therapeutics)and other international organizations -- Ensures that learning follows professional industry standards.

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Safety Pharmacology In Pharmaceutical Development And Approval

Providing detailed coverage of an emerging discipline within the pharmaceutical industry, Safety Pharmacology in Pharmaceutical Development and Approval lays out exactly the whys and hows of safety pharmacology testing. The book covers the background, history, and concerns that have evolved from lackluster safety pharmacology activities in the past. It details regulatory requirements, provides comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery. The author addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into existing safety evaluations.

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Encyclopedia of Clinical Pharmacy

This reference presents the latest procedures, practice guidelines, consensus documents, technological strategies, and regulatory standards for optimal pharmaceutical care--offering summaries for practical applications in a variety of clinical settings, including community and health-system pharmacies, clinics, hospice and long-term care facilities, government agencies, and pharmaceutical research and development organizations.

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A Practical Guide to Quality Management in Clinical Trial Research

Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis. The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.

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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Patkage Integrity Testing: Third Edition

Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.

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http://rapidshare.com/files/135471632/tparenteralqc.zip

Who Expert Committee on Biological Standardization 55th Report

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterization and establishment of international and other biological reference standards. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.

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Who Expert Committee on Biological Standardization: Fifty-sixth Report

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on quality, safety and effi cacy of live attenuated rotavirus vaccines; DNA vaccines; a biosafety risk assessment for production and quality control of human infl uenza pandemic vaccines; recommendations for inactivated rabies vaccines produced in cell substrates and embryonated eggs; for whole cell pertussis vaccine; and for production, control and regulation of human plasma for fractionation. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.

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Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

Covering the recently passed 45 CFR, and the parallel CFR 21 Part 11 and HIPAA regulations 160, 162, and 164, this book provides guidance for purchasing, installing, validating, and managing commercial off-the-shelf software data for collection and retention. Addressing the interface between these regulations and how to be in compliance with them, the authors cover audit trails, validation, documentation, training, and how to establish and maintain security and accountability. They discuss what the regulations mean in terms of industry standard, explain the audit function for facilities that are subject to the newer HIPAA regulations, and present the standards for documentation.

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http://rapidshare.com/files/103757737/Ele_recd_keep.zip

ORA Quality Manual, January 2007

The ORA Quality Manual contains the required policy elements to structure the Office of Regulatory Affairs (ORA) Quality Management System (QMS). The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and FDA who wish to understand the ORA QMS. Use of this manual presumes some understanding of quality system principles and standards.

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http://rapidshare.com/files/97417420/Qty.manual07.zip

The Laboratory Quality Assurance System:A Manual of Quality Procedures and Forms

Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual:

-Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories.
-Provides blank forms used in preparing a quality manual.
-Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.

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Dietary Supplements

Dietary Supplements Pocket Companion

This is a pocket companion based on the "MRW, Dietary Supplements". 88 monographs are arranged alphabetically. How to use this book section will be rewritten. The introduction is omitted and aims to use the same symbols as in "Stockley's Pocket Companion".Based on the MRW, Dietary Supplements, this pocket companion will cover truncated versions of the 82 monographs in the large reference work with an additional 6 monographs (88 in total). Monographs will be listed alphabetically and will contain: brief description, constituents, human requirements, dietary sources, action, possible uses (in tabular form), bioavailability, precautions/contraindications, pregnancy and breast-feeding, adverse effects, interactions, dose and brief references (no more than ten per monograph). This title will therefore be a concise, quick reference for health professionals and will include a brief assessment of the latest evidence.

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Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification

Since 1997, the Institute of Medicine has issued a series of nutrient reference values that are collectively termed Dietary Reference Intakes (DRIs). The DRIs offer quantitative estimates of nutrient intakes to be used for planning and assessing diets. Using the information from these reports, this newest volume in the DRI series focuses on how the DRIs, and the science for each nutrient in the DRI reports, can be used to develop current and appropriate reference values for nutrition labeling and food fortification.

Focusing its analysis on the existing DRIs, the book examines the purpose of nutrition labeling, current labeling practices in the United States and Canada, food fortification practices and policies, and offers recommendations as a series of guiding principles to assist the regulatory agencies that oversee food labeling and fortification in the United States and Canada. The overarching goal of the information in this book is to provide updated nutrition labeling that consumers can use to compare products and make informed food choices. Diet-related chronic diseases are a leading cause of preventable deaths in the United States and Canada and helping customers make healthy food choices has never been more important.

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Dietary Supplements 3rd Edition

The use of dietary supplements has continued to increase steadily in recent years with, for example, 40 per cent of UK adults said to be taking such supplements on a regular basis. Although they are widely used, the use of dietary supplements is controversial in relation to their efficacy and safety and much recent research has been published considering these questions. This comprehensive new edition of "Dietary Supplements" has been completed revised and updated to include the latest findings on the most commonly used dietary supplements. This edition contains 82 regularly structured monographs with information on: uses, action, safety (adverse effects, pregnancy, interactions), efficacy, and dosage; full revised and updated with findings from the recent literature on common supplements such as: aloe vera, calcium, creatine, glucosamine, selenium, and vitamin C; includes 10 monographs new to this edition on: methylsulfonylmethane (MSM), nickel, pcynogenol, phytosterols, psyllium, quercetin, resveratrol, silicon, tin and vanadium; considers regulations relating to dietary supplements in UK, Europe and the USA; and useful appendices include a summary of interactions with conventional medicines.

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Pharmaceutical Guidelines

Pharmaceutical Guidelines

Common Technical Document:

ASEAN
ICH

GMP -Drug Product:

INDIA
PIC
USFDA
WHO

GMP-Drug substances:

ICH
PIC
USFDA
WHO

ICH Guidelines:

Efficacy
Multidisciplinary
Quality
Safety

Regulatory Audits:

PIC
WHO

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VALIDATION

Control Systems for Heating, Ventilating, and Air Conditioning

Control Systems for Heating, Ventilating and Air Conditioning, Sixth Edition contains a comprehensive treatment of heating and air conditioning system controls. This book was originally written to provide fundamentals of HVAC control to practitioners who were designing new control systems or maintaining existing control systems. Emphasis on fundamental control system principles along with the psychrometrics of air conditioning processes has remained a focus of the new edition. While control system technology has changed drastically over the years, the fundamentals of controlling heating and air conditioning systems have changed only modestly.

Readers will find that fundamentals of existing control systems remain in this book so that those who need to maintain or troubleshoot systems that are twenty or thirty years old will be able to see what practitioners did during that time frame. In addition the ubiquitous application of digital control technology in very recent times is also described. Note that the fundamental control principles once implemented pneumatically are now being implemented in modern digital computers - software now replaces hardware. Another change since the last addition is a new emphasis on controlling minimum fresh air for validation purposes. New techniques for doing this have been developed in response to ASHRAE Standard 62, "Ventilation for Acceptable Indoor Air Quality," and these methods are included.

Control Systems for Heating, Ventilating and Air Conditioning, Sixth Edition is complete and covers both hardware control systems and modern control technology. The material is presented without bias and without prejudice toward particular hardware or software. Readers with an engineering degree will be reminded of the psychrometric processes associated with heating and air conditioning as they learn of the various controls schemes used in the variety of heating and air conditioning system types they will encountered in the field. Maintenance technicians will also find the book useful because it describes various control hardware and control strategies that were used in the past and are prevalent in most existing heating and air conditioning systems.

Designers of new systems will find the fundamentals described in this book to be a useful starting point, and they will also benefit from descriptions of new digital technologies and energy management systems. This technology is found in modern building HVAC system designs.

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Sterilization Validation and Routine Operation Handbook: Radiation

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook, Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

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The Clinical Audit in Pharmaceutical Development

MORIAH Consultants, Yorba Linda, CA. Addresses current issues and trends in the validation and auditing of a clinical study. Covers the concepts of clinical studies and data verification and validation, including the general concept of Good Clinical Practice (GCPs), monitoring, and the role of agencies.

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British National Formulary 57: March 2009

This is the authoritative guide to prescribing, dispensing and administering medicines for all health care professionals. Nobody working in health care can afford to be without the latest edition of "BNF". Compiled with the advice of clinical experts and continually updated to reflect the latest evidence from all credible sources worldwide, this essential reference provides up-to-date guidance on prescribing, dispensing, administering, and monitoring medicines. Not only does the "BNF" include the widely accepted framework for the drug management of common diseases, it also includes details of medicines prescribed in the UK, with special reference to their uses, cautions, contraindications, side-effects, dosage and relative costs. This allows treatment to be tailored to the individual needs of each patient. Updated in print every six months by an expert team of pharmacists, with guidance and validation from a network of leading clinicians, and oversight by a Joint Formulary Committee with representatives from all spheres of clinical practice. "The BNF" reflects current best practice as well as legal and professional guidelines relating to the use of medicines. As a result it is used widely as a touchstone reference, and cited in Parliaments and courts as a source of authority.

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Real World Drug Discovery: A Chemist's Guide to Biotech and Pharmaceutical Research

Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, pharmacokinetics, proteomics, phenotype assays, biomarkers, and many other unfamiliar topics for which a basic understanding must somehow be obtained. Even the more experienced scientist can find it frustratingly difficult to get an overview of the many factors involved in modern drug discovery and often only after years of exploring does a whole and integrated picture emerge in the mind of the researcher.

Real World Drug Discovery: A Chemists Guide to Biotech and Pharmaceutical Research presents this kind of map of the landscape of drug discovery. In a single, readable volume it outlines processes and explains essential concepts and terms for the recent science graduate wondering what to expect in pharma or biotech, the medicinal chemist seeking a broader and more timely understanding of the industry, or the contractor or collaborator whose understanding of the commercial drug discovery process could increase the value of his contribution to it.

Key Features:

- Interviews with well-known experts in many of the fields involved, giving insightful comments from authorities on many of the sub-disciplines important to cutting edge drug discovery.

- Helpful suggestions gleaned from years of experience in biotech and pharma, which represents a repository drug discovery "lore" not previously available in any book.

- "Periodic Table of Drugs" listing current top-selling drugs arranged by target and laid out so that structural similarities and differences are plain and clear, with regular updates available at the book's website.

- Extensive use of diagrams to illustrate concepts like biotech startup models, preteomic profiling for target identification, Gantt charts for project planning, etc.

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Principles and Practices of Method Validation Proceedings

Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a larege number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.

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Biopharmaceutical Process Validation

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.

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Sterilisation of Polymer Healthcare Products

"The use of polymers in medical technology continues to grow and provides major business opportunities for companies who service the medical industry. Sterilisation has always been challenging but sterilisation of polymer healthcare products is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This comprehensive reference supplies insights into this developing field.

Sterilisation of Polymer Healthcare Products offers a thorough description of the conventional methods of ethylene oxide, gamma and electron-beam radiation, steam and dry heat sterilisation as well as covering newer methods such as hydrogen peroxide/plasma, gluteraldehyde, steam - formaldehyde, peracetic acid, chlorine dioxide and ozone.

With the many possible ways to sterilise healthcare products, and new techniques being developed all the time, the author identifies the variety of factors and functions that must be taken into account, such as the requirement for an understanding of physical, chemical and biological properties, design and manufacturing processes, quality control and regulatory issues.

This book discusses the evaluation of candidate materials and components for compatibility with the different sterilisation methods. From this point methods may be chosen and materials screened for biocompatibility, devices manufactured and samples tested, and a validation process chosen.

Sterilisation of Healthcare Products is a necessary and worthwhile reference for medical device manufacturers and polymer suppliers, as well as purchasing and quality assurance managers in the healthcare industry. It is designed to be of use to anyone already working in the field of sterilisation of healthcare products but it will be equally useful to someone about to start working in the field. "

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Pharmaceutical Engineering - Jan/Feb 2009

Articles:

• Fundamentals of Bacterial Adhesion Applied Toward Infection Prevention: Focus on Two Case Studies
  
• ISPE Update
  
• Classified Advertising
  
• Advertiser’s Index
  
• Online Total Organic Carbon (TOC) as a Process Analytical Technology for Cleaning Validation Risk Management Using Visible Residue Limits for Cleaning
• Industry Interview Series: Senior Staff Members from China’s State Food and Drug Administration (SFDA)
  
• Beyond the Bell Curve: A Report on Managing Capital Project Risk
  

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Ion Exchange and Solvent Extraction: A Series of Advances, Volume 16

Presenting key advancements in the areas of ion exchange and solvent extraction on par with the high-level research consistently related by this series, Volume 16 discusses the ion-exchange isothermal supersaturation technique, metal separation via pH-induced parametric pumping, modeling of ion-exchange kinetics for ultrapure water, ion-exchange properties of engineered carbons and carbonaceous materials, and many more topics.

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Good Design Practices for GMP Pharmaceutical Facilities

A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.

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Microbial Contamination Control in Parenteral Manufacturing

This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.

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Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition

A Practical Guide to Microbial Limit Methodologies

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies.

Includes New and Updated Material

Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation.

Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

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Analytical Instrumentation: Performance Characteristics and Quality

There is an increasing need for analysts to understand and be able to quantify the performance of analytical instruments, in particular with respect to the following:

* specifying equipment for purchase
* estimating uncertainties in intrumental measurements
* quantifying and demonstrating performance quality

This text links together an understanding of performance characteristics with an appreciation of the limitations imposed by instrument design, leading to the interplay of the validation and qualification processes within quality assurance systems.
A unique framework of topics covers the major instrumental techniques of spectrophotometry, chromatography, capillary electrophoresis, and atomic emission spectroscopy. The use of over 200 questions and answers, together with cross-referencing, helps to develop a thorough understanding of the various concepts that underpin the different techniques.
This book will appeal to a broad range of professional chemists, technicians and students, weither with reference to specific analytical techniques, or within a general course of study in instrumental performance. Analytical Techniques in the Sciences-This series of books provides coverage of all the major analytical techniques and their application in the most important areas of physical, life and materials sciences. Each text is presented in an open learning/distant learning style, in which the learning objectives are clearly identified. The reader's understanding of the material is constantly evaluated by the use of self-assessment and discussion questions.

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Modern Practice of Gas Chromatography

The bible of gas chromatography-offering everything the professional and the novice need to know about running, maintaining, and interpreting the results from GC Analytical chemists, technicians, and scientists in allied disciplines have come to regard Modern Practice of Gas Chomatography as the standard reference in gas chromatography. In addition to serving as an invaluable reference for the experienced practitioner, this bestselling work provides the beginner with a solid understanding of gas chromatographic theory and basic techniques.
This new Fourth Edition incorporates the most recent developments in the field, including entirely new chapters on gas chromatography/mass spectrometry (GC/MS); optimization of separations and computer assistance; high speed or fast gas chromatography; mobile phase requirements: gas system requirements and sample preparation techniques; qualitative and quantitative analysis by GC; updated information on detectors; validation and QA/QC of chromatographic methods; and useful hints for good gas chromatography.
As in previous editions, contributing authors have been chosen for their expertise and active participation in their respective areas. Modern Practice of Gas Chromatography, Fourth Edition presents a well-rounded and comprehensive overview of the current state of this important technology, providing a practical reference that will greatly appeal to both experienced chomatographers and novices.

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Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include paper- and peopleless plants, GxP compliance, integrating manufacturing systems, electronic signatures, validating asset management systems, enterprise/manufacturing planning systems, lab information management systems, and Local & Wide Area Networks, compliance for IT Infrastructure, IT system maintenance and support, and auditing suppliers, software Integrators, and hardware manufacturers.

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Validating Medical Packaging

According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.

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Validated Cleaning Technologies for Pharmaceutical Manufacturing

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

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Target Validation in Drug Discovery

This work presents a comprehensive contemporary framework for approaching target validation in drug discovery. It begins with a detailed description of new enabling technologies, including aptamers, RNA interference, functional genomics, and proteomics. The next section looks at biologic drug development with in-depth discussion of lessons learned from such well-known cases as Erbitux, Herceptin, and Avastin. Additional targets known as "second generation" drugs, which can be identified when disease pathways are validated by biologics, present new possible small molecule therapeutics and serve as the focus of the final section of the book.

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Process Validation in Manufacturing Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

Written by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages.

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