| 000 | 04705nam a22003377i 4500 | ||
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| 005 | 20230913114954.0 | ||
| 008 | 160210s2015 enk||||| b||| 001 0 eng d | ||
| 020 | _a9780857111715 (pbk.) | ||
| 020 | _z9780857111975 (ePub ebook) | ||
| 020 | _z9780857111968 (PDF ebook) | ||
| 020 | _z9780857111982 (Mobipocket ebook) | ||
| 040 |
_aEG-NcFUE _bEG-NcFUE _erda |
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| 082 | 0 | 4 |
_222 _a344.2404233 _bR. |
| 245 | 0 | 0 |
_aRules and guidance for pharmaceutical manufacturers and distributors 2015 / _ccomplied by the Inspection, Enforcement and Standards Division of MHRA. |
| 264 | 1 |
_aLondon : _bPharmaceutical Press, _c2015. |
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| 300 |
_axxiv, 648 pages ; _c25 cm |
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| 336 |
_atext _2rdacontent |
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| 337 |
_aunmediated _2rdamedia |
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| 338 |
_avolume _2rdacarrier |
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| 500 | _apharmacy bookfair2016 | ||
| 504 | _aIncludes bibliographical references and index. | ||
| 505 | 0 | _a 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 | |
| 520 | _aThis 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. | ||
| 650 | 0 |
_aDrugs _xLaw and legislation _zEuropean Union countries. |
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| 650 | 0 |
_aDrugs _xLaw and legislation _zGreat Britain. _915547 |
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| 650 | 0 |
_aPharmacy _xLaw and legislation _zEuropean Union countries. |
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| 650 | 0 |
_aPharmacy _xLaw and legislation _zGreat Britain. _915546 |
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| 710 | 1 |
_aGreat Britain. _bMedicines and Healthcare products Regulatory Agency. _bInspection, Enforcement, and Standards Division, _eeditor |
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_2ddc _cBK |
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_c10303 _d10303 |
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