Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 - The Orange Guide

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 - The Orange Guide

Author: MHRA (Medicines and Healthcare products Regulatory Agency)

Publisher: Pharmaceutical Press

Published: 2015

Hardback, 1 volume

Pages: 672 pp.

Product Dimensions: 244 x 172mm

ISBN: 978 0 85711 171 5

This is the ninth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by MHRA. Commonly known as the Orange Guide, it remains an essential reference for all manufacturers and distributors of medicines in Europe. It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines.

The new 2015 edition incorporates all the significant updates and additions to the detailed European Community guidelines on GMP since the last edition, including the revised EU Guidelines on Good Distribution Practice.

The Book include: In addition, it contains new sections

§  The Gold Standard for Responsible Persons

§  MHRA Innovation Office

§  The Application and Inspection process for new licences – "what to expect”

§  MHRA Compliance Management and Inspection Action Group

§  MHRA Risk-based inspection programme

§  Naming Contract Quality Control (QC) laboratories

§  GDP Quality Systems

§  A new flow chart on registration requirements for UK companies involved in the sourcing and supply of active substances (ASs), to be used in the manufacture of licensed human medicines

Building on the restructured contents and fresh redesign of the last edition, you’ll find all the answers you need to stay informed.

Contents:

1. MHRA: Licensing, Inspection and Enforcement for Human Medicines

2. EU Guidance on Good Manufacturing Practice

Part I: Basic Requirements for Medicinal Products

1. Pharmaceutical Quality System

2. Personnel

3. Premises and Equipment

4. Documentation

5. Production

6. Quality Control

7. Outsourced Activities

8. Complaints, Quality Defects and Product Recalls

9. Self Inspection

Annex 1. Manufacture of Sterile Medicinal Products

Annex 2. Manufacture of Biological Active Substances and Medicinal Products for Human Use

Annex 3. Manufacture of Radiopharmaceuticals

Annex 4. Manufacture of Veterinary Medicinal Products Other than Immunological Veterinary Medicinal Products

Annex 5. Manufacture of Immunological Veterinary Medicinal Products

Annex 6. Manufacture of Medicinal Gases

Annex 7. Manufacture of Herbal Medicinal Products

Annex 8. Sampling of Starting and Packaging Materials

Annex 9. Manufacture of Liquids, Creams and Ointments

Annex 10. Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation

Annex 11. Computerised Systems

Annex 12. Use of Ionizing Radiation in the Manufacture of Medicinal Products

Annex 13. Investigational Medicinal Products

Annex 14. Manufacture of Medicinal Products Derived from Human Blood or Plasma

Annex 15. Qualification and Validation

Annex 16. Certification by a Qualified Person and Batch Release

Annex 17. Parametric Release

Annex 18. Good Manufacturing Practice for Active Pharmaceutical Ingredients

Annex 19. Reference and Retention Samples

Glossary of Terms Used in the EU Guide to GMP

Part II: Basic Requirements for Active Substances Used as Starting Materials

Part III: GMP Related Documents

Site Master File – Explanatory Notes on the Preparation of a Site Master File

Annex Content of Site Master File

Quality Risk Management (ICH Q9)

Annex I. Risk Management Methods and Tools

Annex II. Potential Applications for Quality Risk Management

ICH Q10 Note for Guidance on Pharmaceutical Quality System (ICH Q10)

Annex 1. Potential Opportunities to Enhance Science and Risk Based Regulatory Approaches

Annex 2. MRA Batch Certificate

3. UK Guidance on Manufacture

4. UK Guidance on the Manufacture, Importation and Distribution of Active Substances

5. EU Legislation on Manufacture and Importation

6. UK Legislation on Manufacture and Importation

7. UK Legislation on the Manufacture, Importation and Distribution of Active Substances

8. Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)

9. UK Guidance on Wholesale Distribution Practice

10. UK Guidance on Brokering Medicines

11. EU Legislation on Wholesale Distribution and Brokering Medicines

12. UK Legislation on Wholesale Distribution

13. UK Legislation on Brokering Medicines

Glossary of Legislation

Appendix

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Handbook of Pharmaceutical Excipients, 7 edition

Handbook of Pharmaceutical Excipients, 7 edition

Rowe, Raymond C; Sheskey, Paul J; Cook, Walter G; Fenton, Marian E.

Publisher: Pharmaceutical Press

Edition: 7

Published: 2012

Hardback, 1 volume

Pages: 1064 pp.

Product Dimensions: 276 x 219mm.

Uniquely, the Handbook of Pharmaceutical Excipients collects together the essential data on the physical properties of excipients, drug safety and potential drug toxicity. Information is presented in a structured and easy-to-use format.

Written concisely by leading international experts, the Handbook has become the best first drug reference point for users of excipients across many industries.

Proven worth

Since its launch, drug formulators, drug manufacturers, regulatory associations and legal bodies have established it as the go-to reference work on excipients. Pharmacists and chemists have come to rely upon it as the dependable source of pharmaceutical formulation information. In other industries such as food formulation and cosmetics formulation it has proved its worth time and time again.

Improvements to the Handbook of Pharmaceutical Excipients, 7 edition include:

§  This new 7th edition enhances that value and the Handbook of Pharmaceutical Excipients' reputation for excellence and practicality in the laboratory and library.

§  All drug monographs fully updated in the light of current knowledge

§  Important new content including 40 new drug monographs and IR spectra figures

§  New two colour printing to further enhance usability in daily practice

§  Directory of suppliers updated and indexed by country and by monograph, providing quick access to worldwide trade name and supplier information, including the specific grades or types of excipients that are commercially available.

Monographs benefit from a standardized, easy-to-use template and include:

§  pharmacopoeial information from the UK, Europe, Japan and the United States where relevant

§  non-proprietary names and synonyms

§  chemical name, CAS Registry number, empirical formula, molecular weight

§  functional category, applications and incompatibilities

§  material description and typical excipient properties

§  safety, stability, storage and handling information

§  method of drug manufacture

§  related substances

§  primary references

§  editorial comments

§  author details and revision date

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AATCC Technical Manual 2015

AATCC Technical Manual 2015

Author: American Association of Textile Chemists and Colorists (AATCC)

Language: English

AATCC is probably best known for its standardized test methods and evaluation procedures, compiled in the annual AATCC Technical Manual. Each test method is designated by a number followed by a date, which indicates the year in which the method was issued, last revised, or reaffirmed. The designation should be quoted in full in referring to a particular method.

An important feature of all AATCC test methods is that test results are numerically quantified as opposed to being reported as pass-fail. Test results are the basis for describing material or process characteristics that are not in themselves intended to be performance specifications.

AATCC policy prohibits endorsement of such specifications. Buyer and seller, or regulatory bodies, may establish pass-fail specifications based on the results of AATCC test methods. 

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MEYLER'S Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions (Fifteenth Edition) in 6 Volumens

MEYLER'S Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions (Fifteenth Edition) in 6 Volumens

Editor:                             J.K. Aronson

Publishers:                    ELSEVIER

Format:                          Hardcover in 6 Volumens

Pages:                           4192 pages

Publication date:         2006

Edition number:          15

Product dimensions:   21.00 cm x 28.50 cm

Country Origin:              Great Britain

Key Features:

* Enhanced encyclopedic format with drug monographs now organized alphabetically

* Completely expanded coverage of each drug - thalidomide warranted three sentences in Meyler's 14th edition, but is now a 13 page extensive monograph

* Clearer, systematic organization of information for easier reading including case histories to provide perspective on each listing

* Extensive bibliography with over 40,000 references - Meyler's 15th edition incorporates all relevant citations from Meyler's 14th, but also includes relevant citations from previous editions of Meyler's and Side Effects of Drugs Annuals to give a historical perspective on the use and safety of drugs

Description:

Building on the success of the 14 previous editions, this remarkable reference has been extensively reorganized and expanded and now comprises almost 1,500 individual drug articles providing the most complete coverage of adverse reactions and interactions found anywhere. Each article contains detailed and authoritative information about the adverse effects of each drug, with comprehensive references to the primary literature making this a must have for any academic or medical library, pharmacologist, regulatory organization, hospital dispensary or pharmaceutical company.

Readership:

Academic and medical libraries, clinical pharmacologists, pharmacists in the pharmaceutical industry, regulatory organizations, and hospital dispensaries

Contents:

§  Contributors

§  Foreword

§  Contents

§  How to use this book

§  Overview of Drug Monographs

§  Preface

§  Drug Monographs

§  Index of Drug Names

§  Index of Adverse Reactions

Meet the Author

Dr Jeffrey K. Aronson is a consultant clinical pharmacologist and physician in the Department of Primary Health Care in the University of Oxford in ENGLAND and a consultant physician in the Oxford Radcliffe Hospitals Trust. He has been associated with the Meyler series since 1977 and has published many research papers on adverse drug reactions. He is also the editor of Meyler's Side Effects of Drugs and the Side Effects of Drugs Annual series. He is President of the British Pharmacological Society and serves on many committees concerned with drug therapy, including the Technology Appraisal Committee of the UK’s National Institute for Health and Clinical Excellence (NICE) and the Joint Formulary Committees of the British National Formulary and the British National Formulary for Children.

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