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Rules and Guidance for Pharmaceutical Manufacturers and Distributors , 2017

Publisher: : Pharmaceutical Press, 2017Description: (806 pages).Content type: text Media type: computer Carrier type: online resourceISBN: 9780857112859.Subject(s): Drugs -- Law and legislation -- European Union countries | Drugs -- Law and legislation -- Great Britain | Drugs -- Law and legislation | Pharmacy -- Law and legislation -- European Union countries | Pharmacy -- Law and legislation -- Great Britain | Pharmacy -- Law and legislationGenre/Form: Print books.
Contents:
Cover; Table of Contents; Preface to the 2015 edition; GMP Directive; Changes to the Community Code; UK legislation; Changes to the EU Guide to GMP; The Orange Guide 2015; Acknowledgements; Feedback; Introduction; MHRA; MHRA: Licensing, Inspection and Enforcement for Human 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; Guidanceon Good Manufacturing Practice (GMP)
EU Guidance on Good Manufacturing PracticePART 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 DocumentsSpecifications; 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; Good Quality Control Laboratory Practice; 7 OUTSOURCED ACTIVITIES; Principle; General; The Contract Giver
The Contract AcceptorThe 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 TechnologyTerminally 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 RADIOPHARMACEUTICALS
Summary: 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.
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Current location Call number Status Date due Barcode Item holds
On Shelf RA401 .G7 G74 2017 (Browse shelf) Available AU0000000009468
Total holds: 0

Description based upon print version of record.

Cover; Table of Contents; Preface to the 2015 edition; GMP Directive; Changes to the Community Code; UK legislation; Changes to the EU Guide to GMP; The Orange Guide 2015; Acknowledgements; Feedback; Introduction; MHRA; MHRA: Licensing, Inspection and Enforcement for Human 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; Guidanceon Good Manufacturing Practice (GMP)

EU Guidance on Good Manufacturing PracticePART 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 DocumentsSpecifications; 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; Good Quality Control Laboratory Practice; 7 OUTSOURCED ACTIVITIES; Principle; General; The Contract Giver

The Contract AcceptorThe 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 TechnologyTerminally 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 RADIOPHARMACEUTICALS

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.

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