TOPAKTUELLE
SEMINARE / KONFERENZEN

GMP-Basis-/Einstiegsschulung
14. September 2010, Heidelberg
Mikrobiologisches OOS/OOL
14./15. September 2010, Heidelberg
Mikrobiologisches Umgebungsmonitoring
15./16. September 2010, Heidelberg
Kennzahlen im analytischen Labor
15./16. September 2010, Karlsruhe
Change Control - Von der Planung bis zur Umsetzung der Änderung
16./17. September 2010, Mannheim

SITEMAP

IMPRESSUM

Nr.Titel
2Quality of Biotechnology Products : Analysis of the Expression Construct in Cells Used for Productions of r - DNA - Derived Protein Products (CPMP/ICH/139/95)
4Submitting Samples and Analytical Data for Methods Validation
5Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant -DNA - Derived Product or a Monoclonal Antibody Product for in Vivo use, August 1996
6Format and Content for the CMC Section of an Annual Report, 1994
8NDAs: Impurities in Drug Substances (Feb. 2000)
9Investigating Out of Specification (OOS) results for Pharmaceutical Production
12Changes to an Approved NDA or ANDA, Revision 1
15PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites, April 1998
16SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum
17ORA Inspectional References Guide to Inspectors of Quality Systems, August 1999
19Industry Survey on Current Sterile Filtration Practices
21The Application of the principles of Good Laboratory Practice and the verification of their Application for Tests on Chemical Substances
27Impurities in New Drug Substances
28Impurities in New Drug Products (CPMP/ICH/282/95)
29Quality of Biotechnology Products : Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (CPMP/ICH/295/95)
30Quality of Biotechnological Products : Stability Testing of Biotechnological / Biological Products (CPMP/ICH/138/95)
31Quality of Biotechnological Products Derivation and Characterisation of Cell Substrates used for the Production of Bio. Products (CPMP/ICH/294/95)
32Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
33Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
34Impurities: Residual Solvents (CPMP/ICH/283/95)
36Q1A(R2) Stability Testing of new drugs and products (Revised guideline)
38Q3B(R2) Impurities in New Drug Products
40Stability Testing of Drug Substances and Drug Products
42SUPAC-IR Immediate Release Solid Oral Dosage Forms, Scale - Up and Post-approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, In Vivo Bioequivalence Documentation, Guidance November 1995
43Guidance for Industry 21 CFR Part 11, Electronic Records, Electronic Signatures: Validation
44Guidance for Industry 21 CFR Part 11, Electronic Records, Electronic Signatures: Glossary of Terms
47Drug Master Files for Bulk Antibiotic Drug Substances
48The Sourcing and Processing of Gelatin to reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy, December 2000
49SUPAC-IR: Questions and Answers about SUPAC-IR Guidance
50Reviewer Guidance: Validation of Chromatographic Methods, 1994
54Draft on a legislative proposal on GMP for starting materials and inspection of manufacturers of both medicinal products and starting materials
55Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients
56BACPAC I: Intermediates in Drug Substance Synthesis, Bulk Actives Post-approval Changes: Chemistry, Manufacturing and Controls Documentation, February 2001
58CPMP/QWP/122/02, rev 1 - Note for Guidance on Stability Testing of Existing Active Substances and Related Finished Products
60CPMP/QWP/155/96 Note for guidance on development pharmaceutics (CPMP adopted Jan. 98)
62CPMP/QWP/609/96 Rev 1 Note for guidance on Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances (Annex to note for Guidance on Stability Testing of New Active Substances and Medicinal Products, Annex to Note for Guidance on Stability of Existing Active Substances and Related Finished Products) (Date of coming into operation October 2003), Rev 2 withdrawn
65CPMP/QWP/158/96 Note for guidance on dry Powder Inhalers
68CPMP/QWP/054/98 Annex to Note for guidance on Development Pharmaceutics (CPMP/QWP/155/96): Decision Trees for Selection of Sterilisation Methods
77Guide to Inspection of Bulk Pharmaceuticals Chemicals, May 1994
78Manufacturing, Processing Or Holding of Active Pharmaceutical Ingredients (APIs), March 1998
79Computerized Systems used in clinical trials-Draft
80Drug Master Files, September 1989
84Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
90Guideline for the Manufacture of Active Pharmaceutical Ingredients (PH 2 / 87 )
91Aide-Memoire for the inspection of blood donation and plasmapheresis
94Guidelines for the manufacture of veterinary medicinal products
96Good Manufacturing Practices : Guidelines on the Validation of Manufacturing Processes (in WHO Technical Report Series 863, 1996)
102Explanatory Note for Industry on the Preparation of a Site Master File (PE 008-3) Sept 2007
104Resolution AP-CSP(99)4 des Council of Europe, Public Health Committee
105ISPE Baseline Guide Bulk Pharmaceutical Chemicals Pharmaceutical Engineering Guide
108Aseptic processing of health care products- Part 1: General requirements
109Validation of Aseptic Processing (PI 007-5) 2009
110Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations
111Validation of Computer-related Systems TR 18
112Inspection of Computer Systems
113Validation and Qualification of Computerized Laboratory Data Acquisition Systems
114Complying with 21 CFR Part 11 Electronic Records and Electronic Signatures
11521 CFR Part 211 Current Good Manufacturing Practice
116Guide to Inspections of Computerised Systems in Drug Processing, February 1983
11721 CFR Part 11 Electronic Records, Electronic Signatures
118Human Drug CGMP Notes
119Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004
120Annex 1: Manufacture of Sterile Medicinal Products - revision November 2008
121Annex 2: Manufacture of Biological Medicinal Products for Human Use
122Annex 3: Manufacture of Radiopharmaceuticals (Revision September 2008)
124Annex 5: Manufacture of Immunological Veterinary Medicinal Products
125Annex 6: Manufacture of Medicinal Gases
127Annex 8: Sampling of Starting and Packaging Materials
128Annex 9: Manufacture of Liquids, Creams and Ointments
129Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
130Annex 11: Computerised Systems Draft
131Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products
138Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
139Design Concepts for the Validation of a Water-for-Injection System
140Sterile Pharmaceutical Packaging: Compatibility and Stability
141Depyrogenation
142Review of Commercially Available Particulate Measurement Systems
143Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers
144Sterilization of Parenterals by Gamma Radiation
145Siliconization of Parenteral Drug Packaging Components
146Fundamentals of a Microbiological Environmental Monitoring Program
147Industry Perspective on the Validation of Column-Based Separation Processes for the Purification of Proteins
148Industrial Perspective on Validation of Tangential Flow Filtration in Bio-pharmaceutical Application
149Effect of Gamma Irradiation on Elastomeric Closures
150Current Practices in the Validation of Aseptic Processing
151Rapid/Automated ID Methods Survey
152Report on Survey of Current Industry Gowning Practices
153Bioburden Recovery Validation
154Design And Validation Of Isolator Systems For The Manufacturing And Testing Of Health Care Products
155Contamination Risks in the Manufacture of Parenterals
156Inspecting the Manufacture of Sterile Products, Current and Future Trends
158Annex 1: Manufacture of sterile Medicinal Products, PDA Commentary
159Recommendations on Sterility Testing (PI 0012-3) Sept 2007
160Process Simulation Testing for Aseptically filled Products
161Sterilizing Filtration of Liquids
162Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat
163ISPE Baseline Guide: Biotech
164ISPE Baseline Guide: Guide Water and Steam Systems
165ISPE Baseline Guide: Oral Solid Dosage Guide
166ISPE Baseline Guide: Sterile Manufacturing Facilities
167ISPE SUPAC Guide (Similar Equipment)
170Validation of Steam Sterilisation Cycles: Technical Monographs Nr. 1
171Current Practices in the Validation of Aseptic Processing
172Blend Uniformity Analysis: Validation and In-Process Testing
173Points to Consider for Cleaning Validation
174Pharmaceutical Package Integrity
175PDA - Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals
176Annex 15: Qualification and Validation
177Annex 16: Certification by a Qualified Person and Batch release
178Annex 17: Parametric Release
180ISPE Baseline Guide: Commissioning and Qualification
181ISPE Baseline Guide: Packaging and Warehousing
206General Principles of Process Validation´, May 1987
207Guide to Inspections of Cosmetic Product Manufacturers, February 1995
208Guide to Inspections of Oral Solutions and Suspensions, August 1994
209Guide to Inspections of Sterile Drug Substance Manufacturers, July 1994
210Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation, January 1994
211Guide to Inspections of Dosage Form Drug Manufacturers, October 1993
212Guide to Inspections of Validation of Cleaning Processes, July 1993
213Guide to Inspections of Pharmaceutical Quality Control Laboratories, July 1993
214Guide to Inspections of High Purity Water Systems, July 1993
215Guide to Inspections of Lyophilisation of Parenterals, July 1993
216Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, July 1993
217Guide to Inspections of Topical Drug Products, July 1994
218Sterilization Process Validation, January 1993
220Guide to Inspections of Foreign Pharmaceutical Manufacturers, (5/96)
221Biotechnology Inspection Guide, November 1991
223Compliance Policy Guides - Enforcement Policy: 21 CFR Part 11, Electronic Records; Electronic Signatures (CPG 7153.17)
257Biological Testing of Medicinal and Dental Materials and Devices Part 1: Guidance on Selection Tests
258Medizinproduktegesetz
259Validation for Medical Devices and Diagnostic Manufacturers
261Evaluation, Validation and Implementation of New Microbiological Testing Methods
262PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S 1/95(Rev.4)) November 2007
267Principles of Qualification and Validation in Pharmaceutical Manufacture
268Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures: Electronic Copies of Electronic Records
269Note for Guidance on Process Validation
270ISO 13683 Sterilization of health care products
271Medical devices -- Application of risk management to medical devices - Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte
273Quality systems Medical devices - Particular requirements for the application of ISO 9001
276FIP Guidelines for Dissolution Testing of Solid Oral Products
280Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures: Time Stamps
281Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures: Maintenance of Electronic Records
283Note for Guidance on Start of Shelf-Life of the Finished Dosage Form
285Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products
286Note for Guidance on Medicinal Gases: Pharmaceutical Documentation
287Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products
288Note for Guidance on Quality of Water for Pharmaceutical Use (Rev.)
290Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be forwarded in the Part II of the Dossier for a Marketing Authorisation
292Guideline on the Investigation of Bioequivalence
295Note for Guidance on Stability Testing of Existing Active Substances and Related Finished Products
298Note for Guidance on Impurities: Residual Solvents - Permissible Daily Exposure for Tetrahydrofuran and N-Methylpyrrolidone
299Note for Guidance on Impurities in New Drug Products
319Certificate of Pharmaceutical Product - Application Instructions -
322Standard Abbreviations (Acronyms)
325Preamble to Title 21, Subchapter C, Human and Veterinary Drugs, Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding
32621 CFR Part 800 Medical Devices - General
32721 CFR Part 820 (Quality System Regulation)
32821 CFR Part 7 Enforcement Policy
32921 CFR Part 600 Biological Products: General
33021 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components
33121 CFR Part 610 General Biological Products Standards
33221 CFR Part 314 Applications for FDA approval to market a new drug
33321 CFR Part 314.81 Other Postmarketing Reports (including Annual Report)
33421 CFR Part 312 Investigational New Drug Application
340Glossary of Computerized System and Software Development Terminology
342Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices
344Guide to Inspections of Medical Device Manufacturers (12/97)
358Guide to Inspections of Foreign Medical Device Manufacturers (9/95)
378Guide to International Inspections and Travel
379Compliance Program Manual
380Medical Device Reporting: An Overview
381Compliance Program Guidance Manual 7348.808 Good Laboratory Practice (02/2001)
382Compliance Program Guidance Manual 7356.002 Drug Manufacturing Insections (02/2002)
383ISPE Good practice Guide Commissioning and Qualification of Pharmaceutical Water and Steam Systems
387Guide to Inspections of Quality Systems (08/99)
388Q 9: ICH Draft Consensus Guideline: Q9 Quality Risk Management
467DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS
468"Do It By Design: An Introduction to Human Factors in Medical Devices"
470Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System Regulation
471General Principles of Software Validation; Final Guidance for Industry and FDA Staff
475Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
479Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolided version: 30/12/2008).
481Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation
4822001/20/EC - Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use - English Version
485Guide to Bioresearch Monitoring Inspections of in vitro Diagnostic Devices
490Alternative to Certain Prescription Device Labeling Requirements
492Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems
494Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Final Guidance for Industry and FDA
496Guide to Inspections of Infectious Disease Marker Testing Facilities
497Third Party Review; An Instruction Manual For Conducting Reviews of Premarket Notifications
498Premarket Approval Manual
500HHS Publication FDA 96-4159 - Investigational Device Exemptions Manual
502In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
510Environmental Assessment of Human Drug and Biologics Applications
511Format and Content of the Chemistry, Manufacturing and Controls Section of an Application
518SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
519SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In-Vitro Release Testing and In Vivo Bioequivalence Documentation
522Submission of Chemistry, Manufacturing and Controls Information for Synthetic Peptide Substances
523Submitting Documentation for the Manufacture of and Controls for Drug Products
526Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
 

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