Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022
Author: Medicines and Healthcare Products Regulatory Agency
Publisher:
Published: 2022-03-07
Total Pages: 1140
ISBN-13: 9780857114396
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Dietary Supplements
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher:
Published: 1998
Total Pages: 32
ISBN-13:
DOWNLOAD EBOOKRules and Guidance for Pharmaceutical Distributors 2007
Author: Ed Mhra
Publisher:
Published: 2007-06
Total Pages: 0
ISBN-13: 9780853697589
DOWNLOAD EBOOKComplied by the Medicines and Healthcare products Regulatory Agency (MHRA), this title provides guidance for distributors of medicines for human use in Europe. It presents useful information to ensure the safe distribution of medicines and the safety of the public.
Good Manufacturing Practices for Pharmaceuticals
Author: Joseph D. Nally
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 418
ISBN-13: 1420020935
DOWNLOAD EBOOKWith 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.
Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Published: 2008-03-11
Total Pages: 1386
ISBN-13: 0470259809
DOWNLOAD EBOOKThis handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
WHO guideline on country pharmaceutical pricing policies
Author:
Publisher: World Health Organization
Published: 2020-09-29
Total Pages: 70
ISBN-13: 9240011870
DOWNLOAD EBOOKIn recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Published: 2008-04-04
Total Pages: 857
ISBN-13: 0470259825
DOWNLOAD EBOOKWith its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Guideline on General Principles of Process Validation
Author:
Publisher:
Published: 1987
Total Pages: 32
ISBN-13:
DOWNLOAD EBOOKICH Quality Guidelines
Author: Andrew Teasdale
Publisher: John Wiley & Sons
Published: 2017-09-29
Total Pages: 624
ISBN-13: 1118971132
DOWNLOAD EBOOKExamining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2011-04-03
Total Pages: 442
ISBN-13: 0309158060
DOWNLOAD EBOOKRare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
