Pharmaceutical Quality Assurance guidelines, 10th edition

The 10th edition of the Quality assurance of pharmaceuticals: a compendium of guidelines and related materials is an essential resource for the global healthcare community, designed to strengthen pharmaceutical standards worldwide.

The compendium, developed for national regulatory authorities, pharmaceutical manufacturers, healthcare professionals, and procurement agencies, is instrumental in upholding the globally acceptable standards of good manufacturing practices (GMP) and inspections. With forty-six guidelines, including eight new and ten revised ones, it provides a comprehensive framework for enhancing regulatory systems and international standards for pharmaceutical quality assurance.

The recent alerts on contaminated paediatric syrup medicines underline the urgency for strengthened measures in pharmaceutical manufacturing and for Member States to enforce these international standards to safeguard public health. Applying internationally acceptable standards supports local and regional production of medicines and the quality and safety of medicines circulating in international commerce.

In the context of global healthcare, the 10th edition of the WHO Quality Assurance of pharmaceuticals compendium, volume 2, is a commitment towards ensuring the quality, safety, and efficacy of pharmaceuticals worldwide. The compendium is one of several WHO initiatives aimed to strengthen quality assurance and access to medicines.

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Good Manufacturing Practices and Inspection (Quality Assurance of Pharmaceuticals) by WHO

Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel.

Many of the relevant documents endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control, and in the pharmaceutical industry.

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Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories

Offers guidance for the implementation of a quality management system in drug testing laboratories: a commitment to quality and continuous improvement.
The quality of analyses and results of drug analysis laboratories have significant implications for the justice system, law enforcement, crime prevention and health policy, as well as for the international harmonization and worldwide exchange and coordination of drug information and data. The document aims to provide guidance to deliver high quality in a forensic laboratory, use the appropriate techniques to find the "answers" and to improve it constantly. It is a "how to do document" and includes some areas that are not explicitly covered in depth by ISO 17025.

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Handbook of Pharmaceutical Excipients, 6th Edition

"The Handbook of Pharmaceutical Excipients" is internationally recognised as the authoritative source of information on pharmaceutical excipients. "The Handbook of Pharmaceutical Excipients" is a comprehensive guide to the uses, properties and safety of pharmaceutical excipients and is an essential reference for those involved in the development, production, control or regulation of pharmaceutical preparations. The handbook collects together essential data on the physical properties of excipients as well as providing information on their safe use and potential toxicity. All monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names.

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Martindale: The Complete Drug Reference, 36th Edition

This book provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world. Each new drug licensed for use has its own potential benefits and adverse effects, and its own profile for dosage, administration and indications. Furthermore, manufacturers make regular changes to existing drug names and formulations, which can affect their interactions and safe usage. Health professionals require the correct answers and need to have confidence in the drugs information they use - but with medicines evolving at this rate, how can they be sure their knowledge is up to date? "Martindale" contains up to date information about more than 5,800 substances. Each and every entry is reviewed by our pharmaceutical editors to ensure health professionals have the most current data. Formulations change. Definitions change. Names change. But you can always trust "Martindale".

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Pharmaceutical Drug Analysis

During the past two decades, there have been magnificent and significant advances in both analytical instrumentation and computerized data handling devices across the globe. In this specific context the remarkable proliferation of windows-based computer software stretched overwhelmingly towards instrument control, real time data handling abilities and the ultimate usage of Laboratory Information Management Systems (LIMS) are surprisingly noteworthy.

Pharmaceutical Drug Analysis in its present form essentially comprises six parts containing in all 32 well-elaborated chapters predominantly dealing with the set of descriptive analytical methodologies developed to control and assure the quality of the final marketed product; and, therefore, includes both qualitative and quantitative methods of analysis to help in the identification as well as purity of the product.

The main purpose of this textbook is to discuss in an explicit and lucid manner several of the newer methods that now find rather wider application in the domain of pharmaceutical analysis. The basic principle of each technique is critically treated with emphasis on factors that directly affect its proper and judicious application to various analytical problems. An in-depth knowledge of these principles, instrumentations, modus operandi, experimental parameters, and sample preparation procedures in order to optimize the performance procedure of typical assay of pharmaceutical secondary products i.e., dosage forms, calculations etc., along with cognate assays from the Official Compendia have been included profusely.

Undergraduate and postgraduate students of pharmaceutical drug analysis, quality assurance chemists, industrial trainees, bulk-drug professionals and those in related disciplines earnestly requiring a substantial fundamental understanding and knowledge of the subject will certainly find this a much needed suitable compilation for reading and reference.

The broad coverage included in each of the selected analytical techniques would render Pharmaceutical Drug Analysis to be an useful source of ideas, inspiration for research, and developing newer practical solutions to problems in the ever expanding field of pharmaceutical analysis.

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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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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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International Pharmaceutical Product Registration

This reference text for the pharmaceutical industry sets out the regulatory requirements of the authorities of the major world market. The editors identify major key technical and scientific areas in any application for marketing authorization.

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Handbook of Pharmaceutical Controlled Release Technology

Cambridge Scientific, Inc., MA. Review the design, fabrication, methodology, administration, and classifications of various drug delivery systems, including matrices and membrane-controlled reservoir, bioerodible, and pendant chain systems. Expanded-outline format.

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Preventing Medication Errors: Quality Chasm Series

In 1996, the Institute of Medicine launched the "Quality Chasm Series", a series of reports focused on assessing and improving the nation's quality of health care. "Preventing Medication Errors" is the newest volume in the series. Responding to the key messages in earlier volumes of the series - "To Err Is Human" (2000), "Crossing the Quality Chasm" (2001), and "Patient Safety" (2004) - this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. "Preventing Medication Errors" also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

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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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Analytical Measurement Terminology: Handbook of Terms Used in Quality Assurance of Analytical Measurement

This unique handbook explains the most commonly used terminology and places each term in context. Concepts are described in a way that make them meaningful to practitioners and in line with "official definitions" developed by international organizations.

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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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Quality and Costs

This section discusses how quality has an impact on the costs of goods and services in an organization.Section 7, Quality and Income,addresses the issue of quality and sales revenue. Thus, the two sections provide a framework of how quality is related to the total financial picture of an organization. We identify and measure the costs associated with poor quality for three reasons: to quantify the size of the quality problem to help justify an improvement effort, to guide the development of that effort, and to track progress in improvement activities. Among the concepts and methodologies covered are traditional categories of quality costs, a broadened concept of categories including lost revenue and process capability costs, activity-based costing, data collection methods, return on quality, presentation of findings, gaining approval for an improvement effort, using cost data to support continuous improvement, optimum quality level, and reporting cost data. The underlying theme in the section is the use of quality-related costs to support a quality improvement effort rather than as a system of reporting quality costs.

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Development of Biopharmaceutical Parenteral Dosage Forms

This up-to-the-minute reference delineates;in a systematic fashion;the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products;covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

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Impurities Evaluation of Pharmaceuticals

Filling a gap in the pharmaceutical literature, this unique guide addresses the development of targeted methodologies to monitor impurities in pharmaceutical compounds and drug products. Furnishes physicochemical protocols to determine the purity of pharmaceutical compounds fully before pharmacological and toxicological studies begin! Providing a clear definition of the subject, Impurities Evaluation of Pharmaceuticals introduces various techniques for isolating and characterizing impurities presents guidelines to evaluate stability using kinetic studies shows how to develop stability-indicating methodologies details various methods that require minimal sample prepreparation gives regulatory perspectives on chiral impurities and more! Containing important literature citations and offering an invaluable list of applications, Impurities Evaluation of Pharmaceuticals is an outstanding resource for pharmacists and pharmacologists, clinical microbiologists, quality assurance and production managers in the pharmaceutical industry, analytical chemists and biochemists, pharmaceutical regulatory personnel, and upper-level undergraduate, graduate, and continuing-education students in these disciplines.

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