EC guide to good manufacturing practice for medicinal products for human and veterinary use:
Gespeichert in:
| Vorheriger Titel: | EC guide to good manufacturing practice for medicinal products and active pharmaceutical ingredients |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Aulendorf
ECV - Editio-Cantor-Verl.
2006
|
| Ausgabe: | 5., rev. ed. |
| Schriftenreihe: | Pharmind-Serie Dokumentation
|
| Schlagworte: | |
| Online-Zugang: | Inhaltstext Inhaltsverzeichnis |
| Beschreibung: | 212 S. 21 cm |
| ISBN: | 3871933554 |
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Datensatz im Suchindex
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| adam_text | CONTENT INTRODUCTION COMMISSION DIRECTIVE 2003/94/EC OF 8 OCTOBER 2003
LAYING DOWN THE PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICE
IN RESPECT OF MEDICINAL PRODUCTS FOR HUMAN USE AND INVESTIGATIONAL
MEDICINAL PRODUCTS FOR HUMAN USE COMMISSION DIRECTIVE OF 23 JULY 1991
LAYING DOWN THE PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICE
FOR VETERINARY MEDICINAL PRODUCTS (91/4L2/EEC) GUIDE TO GOOD
MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS FOR HUMAN AND
VETERINARY USE INTRODUCTION OF THE EEC-COMMISSION PART I - BASIC
REQUIREMENTS FOR MEDICINAL PRODUCTS CHAPTER 1: QUALITY MANAGEMENT
(REVISION OCTOBER 2005) PRINCIPLE QUALITY ASSURANCE GOOD MANUFACTURING
PRACTICE OF MEDICINAL PRODUCTS (GMP) QUALITY CONTROL PRODUCT QUALITY
REVIEW CHAPTER 2: PERSONNEL....................... PRINCIPLE GENERAL KEY
PERSONNEL TRAINING PERSONNEL HYGIENE CHAPTER 3: PREMISES AND EQUIPMENT
PRINCIPLE PREMISES - GENERAL - PRODUCTION AREA - STORAGE AREAS - QUALITY
CONTROL AREAS - ANCILLARY AREAS EQUIPMENT 8 12 21 27 29 29 33 37 5
CHAPTER 4: DOCUMENTATION 41 PRINCIPLE GENERAL DOCUMENTS REQUIRED -
SPECIFICATIONS - STARTING AND PACKAGING MATERIALS - INTERMEDIATE AND
BULK PRODUCTS - FINISHED PRODUCTS - MANUFACTURING FORMULA AND PROCESSING
INSTRUCTIONS - PACKAGING INSTRUCTIONS ~ BATCH PROCESSING RECORDS -
BATCH PACKAGING RECORDS - PROCEDURES AND RECORDS - RECEIPT - SAMPLING -
TESTING - OTHER CHAPTER 5: PRODUCTION 47 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 CHAPTER 6: QUALITY CONTROL 5353 PRINCIPLE GENERAL
GOOD QUALITY CONTROL LABORATORY PRACTICE - DOCUMENTATION - SAMPLING -
TESTING - ONGOING STABILITY PROGRAMME (REVISED OCTOBER 2005, COMING INTO
OPERATION ON JUNE I, 2006) CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS
58 PRINCIPLE GENERAL THE CONTRACT GIVER THE CONTRACT ACCEPTOR THE
CONTRACT 6 CHAPTER 8: COMPLAINTS AND PRODUCT RECALL (REVISION DECEMBER
2005, COMING INTO OPERATION ON FEBRUARY I, 2006) . PRINCIPLE COMPLAINTS
RECALLS 60 CHAPTER 9: SELF-INSPECTION PRINCIPLE .. 62 PART II - BASIC
REQUIREMENTS FOR ACTIVE SUBSTANCES USED AS STARTING MATERIALS 63 BASIC
REQUIREMENTS FOR ACTIVE SUBSTANCES USED AS STARTING MATERIALS ANNEXES
ANNEX 1. MANUFACTURE OF STERILE MEDICINAL PRODUCTS (REVISED SEPTEMBER
2003) . ANNEX 2. MANUFACTURE OF BIOLOGICAL 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
(REVISED APRIL 2001) . 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 IONISING RADIATION IN THE
MANUFACTURE OF MEDICINAL PRODUCTS . ANNEX 13. MANUFACTURE OF
INVESTIGATIONAL MEDICINAL PRODUCTS (REVISION I, JULY 2003) . ANNEX 14.
MANUFACTURE OF MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD OR HUMAN
PLASMA .. ANNEX 15. QUALIFICATION AND VALIDATION (REVISED JULY 2001) .
ANNEX 16. CERTIFICATION BY A QUALIFIED PERSON AND BATCH RELEASE (REVISED
JULY 2001) . ANNEX 17. PARAMETRIC RELEASE (REVISED JULY 2001) .. ANNEX
18. GOOD MANUFACTURING PRACTICE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
BASIC REQUIREMENTS FOR ACTIVE SUBSTANCES USED AS STARTING MATERIALS FROM
OCTOBER 2005 COVERED UNDER PART II ANNEX 19. REFERENCE AND RETENTION
SAMPLES (DECEMBER 2005) . 109 123 129 131 133 142 150 152 154 155 157
159 165 180 186 192 200 203 GLOSSARY 207 7
|
| adam_txt |
CONTENT INTRODUCTION COMMISSION DIRECTIVE 2003/94/EC OF 8 OCTOBER 2003
LAYING DOWN THE PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICE
IN RESPECT OF MEDICINAL PRODUCTS FOR HUMAN USE AND INVESTIGATIONAL
MEDICINAL PRODUCTS FOR HUMAN USE COMMISSION DIRECTIVE OF 23 JULY 1991
LAYING DOWN THE PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICE
FOR VETERINARY MEDICINAL PRODUCTS (91/4L2/EEC) GUIDE TO GOOD
MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS FOR HUMAN AND
VETERINARY USE INTRODUCTION OF THE EEC-COMMISSION PART I - BASIC
REQUIREMENTS FOR MEDICINAL PRODUCTS CHAPTER 1: QUALITY MANAGEMENT
(REVISION OCTOBER 2005) PRINCIPLE QUALITY ASSURANCE GOOD MANUFACTURING
PRACTICE OF MEDICINAL PRODUCTS (GMP) QUALITY CONTROL PRODUCT QUALITY
REVIEW CHAPTER 2: PERSONNEL. PRINCIPLE GENERAL KEY
PERSONNEL TRAINING PERSONNEL HYGIENE CHAPTER 3: PREMISES AND EQUIPMENT
PRINCIPLE PREMISES - GENERAL - PRODUCTION AREA - STORAGE AREAS - QUALITY
CONTROL AREAS - ANCILLARY AREAS EQUIPMENT 8 12 21 27 29 29 33 37 5
CHAPTER 4: DOCUMENTATION 41 PRINCIPLE GENERAL DOCUMENTS REQUIRED -
SPECIFICATIONS - STARTING AND PACKAGING MATERIALS - INTERMEDIATE AND
BULK PRODUCTS - FINISHED PRODUCTS - MANUFACTURING FORMULA AND PROCESSING
INSTRUCTIONS - PACKAGING INSTRUCTIONS ~ BATCH PROCESSING RECORDS -
BATCH PACKAGING RECORDS - PROCEDURES AND RECORDS - RECEIPT - SAMPLING -
TESTING - OTHER CHAPTER 5: PRODUCTION 47 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 CHAPTER 6: QUALITY CONTROL 5353 PRINCIPLE GENERAL
GOOD QUALITY CONTROL LABORATORY PRACTICE - DOCUMENTATION - SAMPLING -
TESTING - ONGOING STABILITY PROGRAMME (REVISED OCTOBER 2005, COMING INTO
OPERATION ON JUNE I, 2006) CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS
58 PRINCIPLE GENERAL THE CONTRACT GIVER THE CONTRACT ACCEPTOR THE
CONTRACT 6 CHAPTER 8: COMPLAINTS AND PRODUCT RECALL (REVISION DECEMBER
2005, COMING INTO OPERATION ON FEBRUARY I, 2006) . PRINCIPLE COMPLAINTS
RECALLS 60 CHAPTER 9: SELF-INSPECTION PRINCIPLE . 62 PART II - BASIC
REQUIREMENTS FOR ACTIVE SUBSTANCES USED AS STARTING MATERIALS 63 BASIC
REQUIREMENTS FOR ACTIVE SUBSTANCES USED AS STARTING MATERIALS ANNEXES
ANNEX 1. MANUFACTURE OF STERILE MEDICINAL PRODUCTS (REVISED SEPTEMBER
2003) . ANNEX 2. MANUFACTURE OF BIOLOGICAL 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
(REVISED APRIL 2001) . 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 IONISING RADIATION IN THE
MANUFACTURE OF MEDICINAL PRODUCTS . ANNEX 13. MANUFACTURE OF
INVESTIGATIONAL MEDICINAL PRODUCTS (REVISION I, JULY 2003) . ANNEX 14.
MANUFACTURE OF MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD OR HUMAN
PLASMA . ANNEX 15. QUALIFICATION AND VALIDATION (REVISED JULY 2001) .
ANNEX 16. CERTIFICATION BY A QUALIFIED PERSON AND BATCH RELEASE (REVISED
JULY 2001) . ANNEX 17. PARAMETRIC RELEASE (REVISED JULY 2001) . ANNEX
18. GOOD MANUFACTURING PRACTICE FOR ACTIVE PHARMACEUTICAL INGREDIENTS
BASIC REQUIREMENTS FOR ACTIVE SUBSTANCES USED AS STARTING MATERIALS FROM
OCTOBER 2005 COVERED UNDER PART II ANNEX 19. REFERENCE AND RETENTION
SAMPLES (DECEMBER 2005) . 109 123 129 131 133 142 150 152 154 155 157
159 165 180 186 192 200 203 GLOSSARY 207 7 |
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| index_date | 2024-07-02T15:53:18Z |
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| isbn | 3871933554 |
| language | English |
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| physical | 212 S. 21 cm |
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| series2 | Pharmind-Serie Dokumentation |
| spelling | EC guide to good manufacturing practice for medicinal products for human and veterinary use comp. and ed. by Gert Auterhoff 5., rev. ed. Aulendorf ECV - Editio-Cantor-Verl. 2006 212 S. 21 cm txt rdacontent n rdamedia nc rdacarrier Pharmind-Serie Dokumentation Europäische Gemeinschaften (DE-588)35439-9 gnd rswk-swf GMP-Regeln (DE-588)4113765-6 gnd rswk-swf Europäische Gemeinschaften (DE-588)35439-9 b GMP-Regeln (DE-588)4113765-6 s DE-604 Auterhoff, Gert 1941- Sonstige (DE-588)106846701 oth Parallele Sprachausgabe deutsch EG-Leitfaden einer guten Herstellungspraxis für Arzneimittel 4. ed. u.d.T. EC guide to good manufacturing practice for medicinal products and active pharmaceutical ingredients text/html http://deposit.dnb.de/cgi-bin/dokserv?id=2793222&prov=M&dok_var=1&dok_ext=htm Inhaltstext OEBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015030702&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | EC guide to good manufacturing practice for medicinal products for human and veterinary use Europäische Gemeinschaften (DE-588)35439-9 gnd GMP-Regeln (DE-588)4113765-6 gnd |
| subject_GND | (DE-588)35439-9 (DE-588)4113765-6 |
| title | EC guide to good manufacturing practice for medicinal products for human and veterinary use |
| title_auth | EC guide to good manufacturing practice for medicinal products for human and veterinary use |
| title_exact_search | EC guide to good manufacturing practice for medicinal products for human and veterinary use |
| title_exact_search_txtP | EC guide to good manufacturing practice for medicinal products for human and veterinary use |
| title_full | EC guide to good manufacturing practice for medicinal products for human and veterinary use comp. and ed. by Gert Auterhoff |
| title_fullStr | EC guide to good manufacturing practice for medicinal products for human and veterinary use comp. and ed. by Gert Auterhoff |
| title_full_unstemmed | EC guide to good manufacturing practice for medicinal products for human and veterinary use comp. and ed. by Gert Auterhoff |
| title_old | EC guide to good manufacturing practice for medicinal products and active pharmaceutical ingredients |
| title_short | EC guide to good manufacturing practice for medicinal products for human and veterinary use |
| title_sort | ec guide to good manufacturing practice for medicinal products for human and veterinary use |
| topic | Europäische Gemeinschaften (DE-588)35439-9 gnd GMP-Regeln (DE-588)4113765-6 gnd |
| topic_facet | Europäische Gemeinschaften GMP-Regeln |
| url | http://deposit.dnb.de/cgi-bin/dokserv?id=2793222&prov=M&dok_var=1&dok_ext=htm http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015030702&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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