Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017
Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK drug regulatory body, MHRA, and brings together the European and UK guidance documents and information on legisl...
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| Language: | English |
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Pharmaceutical Press
2017
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| Edition: | 1 |
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| ISBN: | 9780857112859, 0857112856 |
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| Abstract | Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK drug regulatory body, MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation. Changes in this new edition:Revised Annex 15. The revision of Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology.Revised Annex 16. The GMP Guide Annex 16 has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable. Also, some areas, where the interpretation by Member States has not been consistent, have been clarified. This revised Annex came into operation 15 April 2016.The introduction of guidelines on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.The introduction of guidelines on the formalised risk assessment for ascertaining the appropriate GMP for excipients.The addition of the Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01).These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for manufacturers, importers and distributors of active substances for medicinal products for human use. These guidelines should be followed as of 21 September 2015.The addition of the principles and guidelines of Good Manufacturing Practice (GMP) for active substances for medicinal products for human use, including active substances intended for export.Revisions to the UK Human Medicines Regulations 2012.MHRA GMP Data Integrity Definitions and Guidance for Industry is now included which sets out MHRA expectations for data integrity in good manufacturing practice (GMP). The Guidance complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume. |
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| AbstractList | Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK drug regulatory body, MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation. Changes in this new edition:Revised Annex 15. The revision of Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology.Revised Annex 16. The GMP Guide Annex 16 has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable. Also, some areas, where the interpretation by Member States has not been consistent, have been clarified. This revised Annex came into operation 15 April 2016.The introduction of guidelines on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.The introduction of guidelines on the formalised risk assessment for ascertaining the appropriate GMP for excipients.The addition of the Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01).These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for manufacturers, importers and distributors of active substances for medicinal products for human use. These guidelines should be followed as of 21 September 2015.The addition of the principles and guidelines of Good Manufacturing Practice (GMP) for active substances for medicinal products for human use, including active substances intended for export.Revisions to the UK Human Medicines Regulations 2012.MHRA GMP Data Integrity Definitions and Guidance for Industry is now included which sets out MHRA expectations for data integrity in good manufacturing practice (GMP). The Guidance complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume. Commonly known as the Orange Guide, this book is an essential reference for all involved in the manufacture or distribution of medicines in Europe. |
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| Snippet | Commonly known as the Orange Guide, this book is an essential reference for all involved in the manufacture or distribution of medicines in Europe. Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in... |
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| TableOfContents | 3 Quality Management -- 4 Traceability and Post Collection Measures -- 5 Premises and Equipment -- 6 Manufacturing -- 7 Quality Control -- 8 Release of intermediate and finished products -- 9 Retention of plasma pool samples -- 10 Disposal of waste -- Addendum -- ANNEX 15 QUALIFICATION AND VALIDATION -- Principle -- General -- 1. ORGANISING AND PLANNING FOR QUALIFICATION AND VALIDATION -- 2. DOCUMENTATION, INCLUDING VMP -- 3. QUALIFICATION STAGES FOR EQUIPMENT, FACILITIES, UTILITIES AND SYSTEMS -- 5. PROCESS VALIDATION -- 6. VERIFICATION OF TRANSPORTATION -- 7. VALIDATION OF PACKAGING -- 8. QUALIFICATION OF UTILITIES -- 9. VALIDATION OF TEST METHODS -- 10. CLEANING VALIDATION -- 11. CHANGE CONTROL -- 12. GLOSSARY -- ANNEX 16 CERTIFICATION BY A QUALIFIED PERSON AND BATCH RELEASE -- Scope -- General principles -- 1. THE PROCESS OF CERTIFICATION -- 2. RELYING ON GMP ASSESSMENTS BY THIRD PARTIES, E.G. AUDITS -- 3. HANDLING OF UNEXPECTED DEVIATIONS -- 4. THE RELEASE OF A BATCH -- 5. GLOSSARY -- Appendix I -- Appendix II -- ANNEX 17 PARAMETRIC RELEASE -- 1 Principle -- 2 Parametric Release -- 3 Parametric Release for Sterile Products -- 4 Glossary -- ANNEX 19 REFERENCE AND RETENTION SAMPLES -- 1 Scope -- 2 Principle -- 3 Duration of Storage -- 4 Size of Reference and Retention Samples -- 5 Storage Conditions -- 6 Written Agreements -- 7 Reference Samples - General Points -- 8 Retention Samples - General Points -- 9 Reference and Retention Samples for Parallel Imported/Parallel Distributed Products -- 10 Reference and Retention Samples in the Case of Closedown of a Manufacturer -- GLOSSARY OF TERMS USED IN THE EU GUIDE TO GMP -- PART II: Basic Requirements for Active Substances Used as Starting Materials -- 1 Introduction -- 2 Quality Management -- 3 Personnel -- 4 Buildings and Facilities -- 5 Process Equipment -- 6 Documentation and Records Cover -- Table of Contents -- EU referendum -- Preface to the 2017 edition -- GMP Directive -- Changes to the Community Code -- Changes to the EU Guide to GMP -- The Orange Guide 2017 -- Acknowledgements -- Feedback -- Introduction -- Glossary of Legislation -- European Legislation -- UK Legislation -- MHRA -- MHRA: Licensing, Inspection and Enforcement for Medicines -- Overview of the Medicines and Healthcare products Regulatory Agency Group -- Overview of MHRA -- Inspectorate -- The Data Processing Group -- Defective Medicines Report Centre (DMRC) -- Enforcement Group -- Compliance Management and Inspection Action Group -- Advice -- Guidance on Good Manufacturing Practice (GMP) -- EU Guidance on Good Manufacturing Practice -- PART I: Basic Requirements for Medicinal Products -- Introduction -- 1 PHARMACEUTICAL QUALITY SYSTEM -- Principle -- Pharmaceutical Quality System -- Good Manufacturing Practice for Medicinal Products -- Quality Control -- Product Quality Review -- Quality Risk Management -- 2 PERSONNEL -- Principle -- General -- Key Personnel -- Training -- Personnel Hygiene -- Consultants -- 3 PREMISES AND EQUIPMENT -- Principle -- Premises -- Equipment -- 4 DOCUMENTATION -- Principle -- Required GMP Documentation (by type): -- Generation and Control of Documentation -- Good Documentation Practices -- Retention of Documents -- Specifications -- Manufacturing Formula and Processing Instructions -- Procedures and Records -- 5 PRODUCTION -- Principle -- General -- Prevention of Cross-contamination in Production -- Validation -- Starting Materials -- Processing Operations: Intermediate and Bulk Products -- Packaging Materials -- Packaging Operations -- Finished Products -- Rejected, Recovered and Returned Materials -- Product Shortage Due to Manufacturing Constraints -- 6 QUALITY CONTROL -- Principle -- General Internationally harmonised requirements for batch certification in the context of Mutual Recognition Agreements, Agreements on Conformity Assessment and Acceptance of Industrial Products and other appropriate arrangements on GMP with the EU Good Quality Control Laboratory Practice -- 7 OUTSOURCED ACTIVITIES -- Principle -- General -- The Contract Giver -- The Contract Acceptor -- The Contract -- 8 COMPLAINTS, QUALITY DEFECTS AND PRODUCT RECALLS -- Principle -- Personnel and Organisation -- Procedures for Handling and Investigating Complaints including Possible Quality Defects -- Investigation and Decision-making -- Root Cause Analysis and Corrective and Preventative Actions -- Product Recalls and Other Potential Risk-reducing Actions -- 9 SELF INSPECTION -- Principle -- ANNEX 1 MANUFACTURE OF STERILE MEDICINAL PRODUCTS -- Principle -- General -- Clean Room and Clean Air Device Classification -- Clean Room and Clean Air Device Monitoring -- Isolator Technology -- Blow/Fill/Seal Technology -- Terminally Sterilised Products -- Aseptic Preparation -- Personnel -- Premises -- Equipment -- Sanitation -- Processing -- Sterilisation -- Sterilisation by Heat -- Moist Heat -- Dry Heat -- Sterilisation by Radiation -- Sterilisation with Ethylene Oxide -- Filtration of Medicinal Products which cannot be Sterilised in their Final Container -- Finishing of Sterile Products -- Quality Control -- ANNEX 2 MANUFACTURE OF BIOLOGICAL ACTIVE SUBSTANCES AND MEDICINAL PRODUCTS FOR HUMAN USE -- Scope -- Principle -- PART A. GENERAL GUIDANCE -- PART B. SPECIFIC GUIDANCE ON SELECTED PRODUCT TYPES -- GLOSSARY TO ANNEX 2 -- ANNEX 3 MANUFACTURE OF RADIO PHARMACEUTICALS -- Principle -- Introduction -- Quality Assurance -- Personnel -- Premises and Equipment -- Documentation -- Production -- Quality Control -- Reference and Retention Samples -- Distribution -- Glossary -- ANNEX 4 MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS -- Manufacture of Premixes for Medicated Feedingstuffs -- Manufacture of Ectoparasiticides Manufacture of Veterinary Medicinal Products Containing Penicillins -- Retention of Samples (point 1.4 viii and point 6.14) -- Sterile Veterinary Medicinal Products -- ANNEX 5 MANUFACTURE OF IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS -- Principle -- Personnel -- Premises -- Equipment -- Animals and Animal Houses -- Disinfection-Waste Disposal -- Production -- Starting Materials -- Quality Control -- ANNEX 6 MANUFACTURE OF MEDICINAL GASES -- Principle -- Manufacture of Active Substance Gases -- Manufacture of Medicinal Gases -- Glossary -- ANNEX 7 MANUFACTURE OF HERBAL MEDICINAL PRODUCTS -- Principle -- Premises & -- Equipment -- Equipment -- Documentation -- Quality Control -- ANNEX 8 SAMPLING OF STARTING AND PACKAGING MATERIALS -- Principle -- Personnel -- Starting Materials -- Packaging Material -- ANNEX 9 MANUFACTURE OF LIQUIDS, CREAMS ANDOINTMENTS -- Principle -- Premises and Equipment -- Production -- ANNEX 10 MANUFACTURE OF PRESSURISED METERED DOSE AEROSOL PREPARATIONS FOR INHALATION -- Principle -- General -- Premises and Equipment -- Production and Quality Control -- ANNEX 11 COMPUTERISED SYSTEMS -- Principle -- General -- Project Phase -- Operational Phase -- Glossary -- ANNEX 12 USE OF IONISING RADIATION IN THE MANUFACTURE OF MEDICINAL PRODUCTS -- Introduction -- Responsibilities -- Dosimetry -- Validation of the Process -- Commissioning of the Plant -- Premises -- Processing -- Documentation -- Microbiological Monitoring -- ANNEX 13 INVESTIGATIONAL MEDICINAL PRODUCTS -- Principle -- Glossary -- Quality Management -- Personnel -- Premises and Equipment -- Documentation -- Production -- Quality Control -- Release of Batches -- Shipping -- Complaints -- Recalls and Returns -- Destruction -- ATTACHMENT 3 -- ANNEX 14 MANUFACTURE OF MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD OR PLASMA -- Glossary -- 1 Scope -- 2 Principles 7 Materials Management -- 8 Production and In-Process Controls -- 9 Packaging and Identification Labelling of APIs and Intermediates -- 10 Storage and Distribution -- 11 Laboratory Controls -- 12 Validation -- 13 Change Control -- 14 Rejection and Re-Use of Materials -- 15 Complaints and Recalls -- 16 Contract Manufacturers (including Laboratories) -- 17 Agents, Brokers, Traders, Distributors, Repackers, and Relabellers -- 18 Specific Guidance for APIs Manufactured by Cell Culture/Fermentation -- 19 APIs for Use in Clinical Trials -- 20 Glossary -- PART III: GMP Related Documents -- SITE MASTER FILE - EXPLANATORY NOTES ON THE PREPARATION OF A SITE MASTER FILE -- 1 Introduction -- 2 Purpose -- 3 Scope -- 4 Content of Site Master File -- Annex Content of Site Master File -- QUALITY RISK MANAGEMENT (ICH Q9) -- 1 Introduction -- 2 Scope -- 3 Principles of Quality Risk Management -- 4 General Quality Risk Management Process -- 5 Risk Management Methodology -- 6 Integration of Quality Risk Management into Industry and Regulatory Operations -- 7 Definitions -- 8 References -- 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) -- 1 Pharmaceutical Quality System -- 2 Management Responsibility -- 3 Continual Improvement of Process Performance and Product Quality -- 4 Continual Improvement of the Pharmaceutical Quality System -- 5 Glossary -- Annex 1 Potential Opportunities to Enhance Science and Risk Based Regulatory Approaches* -- Annex 2 Diagram of the ICH Q10 Pharmaceutical Quality System Model -- MRA BATCH CERTIFICATE |
| Title | Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017 |
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