Nr.	Titel
2	Quality of Biotechnology Products : Analysis of the Expression Construct in Cells Used for Productions of r - DNA - Derived Protein Products (CPMP/ICH/139/95)
4	Submitting Samples and Analytical Data for Methods Validation
5	Guidance 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
6	Format and Content for the CMC Section of an Annual Report, 1994
8	NDAs: Impurities in Drug Substances (Feb. 2000)
9	Investigating Out of Specification (OOS) results for Pharmaceutical Production
10	Guidance for Industry, ANDA's: Blend Uniformity Analysis
12	Changes to an Approved NDA or ANDA, Revision 1
13	Guidance for Industry Manufacturing Equipment, Addendum to the Guidance for Industry for SUPAC-IR (January 1999)
15	PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites, April 1998
16	SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum, December 1998
17	ORA Inspectional References Guide to Inspectors of Quality Systems, August 1999
19	Industry Survey on Current Sterile Filtration Practices
21	The Application of the principles of Good Laboratory Practice and the verification of their Application for Tests on Chemical Substances
23	Photostability Testing of New Drug Substances and Products (CPMP/ICH/280/95)
24	Stability Testing for New Dosage Forms (CPMP/ICH/280/95)
25	Validation of Analytical Procedures : Definitions and Terminology (CPMP/ICH/281/95)
26	Validation Analytical Procedures : Methodology (CPMP/ICH/281/95)
27	Impurities in New Drug Substances
28	Impurities in New Drug Products (CPMP/ICH/282/95)
29	Quality of Biotechnology Products : Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (CPMP/ICH/295/95)
30	Quality of Biotechnological Products : Stability Testing of Biotechnological / Biological Products (CPMP/ICH/138/95)
31	Quality of Biotechnological Products Derivation and Characterisation of Cell Substrates used for the Production of Bio. Products (CPMP/ICH/294/95)
32	Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
33	Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
34	Impurities: Residual Solvents (CPMP/ICH/283/95)
36	Q1A(R2) Stability Testing of new drugs and products (Revised guideline)
38	Q3B(R2) Impurities in New Drug Products
40	Stability Testing of Drug Substances and Drug Products
42	SUPAC-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
43	Guidance for Industry 21 CFR Part 11, Electronic Records, Electronic Signatures: Validation
44	Guidance for Industry 21 CFR Part 11, Electronic Records, Electronic Signatures: Glossary of Terms
47	Drug Master Files for Bulk Antibiotic Drug Substances
48	The Sourcing and Processing of Gelatin to reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy, December 2000
49	SUPAC-IR: Questions and Answers about SUPAC-IR Guidance
50	Reviewer Guidance: Validation of Chromatographic Methods, 1994
54	Draft on a legislative proposal on GMP for starting materials and inspection of manufacturers of both medicinal products and starting materials
55	Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients
56	BACPAC I: Intermediates in Drug Substance Synthesis, Bulk Actives Post-approval Changes: Chemistry, Manufacturing and Controls Documentation, February 2001
58	CPMP/QWP/122/02, rev 1 - Note for Guidance on Stability Testing of Existing Active Substances and Related Finished Products
60	CPMP/QWP/155/96 Note for guidance on development pharmaceutics (CPMP adopted Jan. 98)
61	CPMP/QWP/159/96 Note for guidance on Maximum Shelf-Life for Sterile Products after First Opening or following Reconstitution (CPMP adopted Jan. 98)
62	CPMP/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
65	CPMP/QWP/158/96 Note for guidance on dry Powder Inhalers
68	CPMP/QWP/054/98 Annex to Note for guidance on Development Pharmaceutics (CPMP/QWP/155/96): Decision Trees for Selection of Sterilisation Methods
71	CPMP/QWP/2934/99 Note for Guidance on In-Use Stability Testing of Human Medicinal Products - Annex to 'Note for Guidance on Stability Testing of Existing Active Substances and related Finished Products' and 'Note for Guidance on Stability Testing of New Drug Substances and Products' (CPMP adopted Feb. 01)
77	Guide to Inspection of Bulk Pharmaceuticals Chemicals, May 1994
78	Manufacturing, Processing Or Holding of Active Pharmaceutical Ingredients (APIs), March 1998
79	Computerized Systems used in clinical trials
80	Drug Master Files, September 1989
84	Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
90	Guideline for the Manufacture of Active Pharmaceutical Ingredients (PH 2 / 87 )
91	Aide-Memoire for the inspection of blood donation and plasmapheresis
94	Guidelines for the manufacture of veterinary medicinal products
95	Good Manufacturing Practices for Pharmaceutical Products (in WHO Technical Report Series 823, 1992)
96	Good Manufacturing Practices : Guidelines on the Validation of Manufacturing Processes (in WHO Technical Report Series 863, 1996)
102	Explanatory Note for Industry on the Preparation of a Site Master File (PE 008-3) Sept 2007
104	Resolution AP-CSP(99)4 des Council of Europe, Public Health Committee
105	ISPE Baseline Guide Bulk Pharmaceutical Chemicals Pharmaceutical Engineering Guide
108	Aseptic processing of health care products- Part 1: General requirements
109	Validation of Aseptic Processing (PI 007-3) Sept 2007
110	Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations
111	Validation of Computer-related Systems TR 18
112	Inspection of Computer Systems
113	Validation and Qualification of Computerized Laboratory Data Acquisition Systems
114	Complying with 21 CFR Part 11 Electronic Records and Electronic Signatures
115	21 CFR Part 210 and 211 Current Good Manufacturing Practice
116	Guide to Inspections of Computerised Systems in Drug Processing, February 1983
117	21 CFR Part 11 Electronic Records, Electronic Signatures
118	Human Drug CGMP Notes
119	Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004
120	Annex 1: Manufacture of Sterile Medicinal Products - revision February 2008
121	Annex 2: Manufacture of Biological Medicinal Products for Human Use
122	Annex 3: Manufacture of Radiopharmaceuticals
123	Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
124	Annex 5: Manufacture of Immunological Veterinary Medicinal Products
125	Annex 6: Manufacture of Medicinal Gases
126	Annex 7: Manufacture of Herbal Medicinal Products
127	Annex 8: Sampling of Starting and Packaging Materials
128	Annex 9: Manufacture of Liquids, Creams and Ointments
129	Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
130	Annex 11: Computerised Systems
131	Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products
138	Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
139	Design Concepts for the Validation of a Water-for-Injection System
140	Sterile Pharmaceutical Packaging: Compatibility and Stability
141	Depyrogenation
142	Review of Commercially Available Particulate Measurement Systems
143	Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers
144	Sterilization of Parenterals by Gamma Radiation
145	Siliconization of Parenteral Drug Packaging Components
146	Fundamentals of a Microbiological Environmental Monitoring Program
147	Industry Perspective on the Validation of Column-Based Separation Processes for the Purification of Proteins
148	Industrial Perspective on Validation of Tangential Flow Filtration in Bio-pharmaceutical Application
149	Effect of Gamma Irradiation on Elastomeric Closures
150	Current Practices in the Validation of Aseptic Processing
151	Rapid/Automated ID Methods Survey
152	Report on Survey of Current Industry Gowning Practices
153	Bioburden Recovery Validation
154	Design And Validation Of Isolator Systems For The Manufacturing And Testing Of Health Care Products
155	Contamination Risks in the Manufacture of Parenterals
156	Inspecting the Manufacture of Sterile Products, Current and Future Trends
157	ISO/TC 198: Aseptic Processing of Health Care Products
158	Annex 1: Manufacture of sterile Medicinal Products, PDA Commentary
159	Recommendations on Sterility Testing (PI 0012-3) Sept 2007
160	Process Simulation Testing for Aseptically filled Products
161	Sterilizing Filtration of Liquids
162	Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat
163	ISPE Baseline Guide: Biotech
164	ISPE Baseline Guide: Guide Water and Steam Systems
165	ISPE Baseline Guide: Oral Solid Dosage Guide
166	ISPE Baseline Guide: Sterile Manufacturing Facilities
167	ISPE SUPAC Guide (Similar Equipment)
169	GAMP-Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacturing, Version 4.0
170	Validation of Steam Sterilisation Cycles: Technical Monographs Nr. 1
171	Current Practices in the Validation of Aseptic Processing
172	Blend Uniformity Analysis: Validation and In-Process Testing
173	Points to Consider for Cleaning Validation
174	Pharmaceutical Package Integrity
175	PDA - Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals
176	Annex 15: Qualification and Validation
177	Annex 16: Certification by a Qualified Person and Batch release
178	Annex 17: Parametric Release
180	ISPE Baseline Guide: Commissioning and Qualification
181	ISPE Baseline Guide: Packaging and Warehousing
182	DIN EN ISO 19011, Publication date:2002-12 Guidelines for quality and/or environmental management systems auditing (ISO 19011:2002); German version EN ISO 19011:2002
185	DIN ISO 10012-1, Publication date:1992-08 Quality assurance requirements for measuring equipment; part 1: metrological confirmation system for measuring equipment; identical with ISO 10012-1:1992
186	DIN EN 45002, Publication date:1990-05 General criteria for the assessment of testing laboratories; Identical with EN 45002:1989
187	DIN EN 45003, Publication date:1995-05 Calibration and testing laboratory accreditation systems - General requirements for operation and recognition (ISO/IEC Guide 58:1993); Trilingual version EN 45003:1995
188	DIN EN 45004, Publication date:1995-06 General criteria for the operation of various types of bodies performing inspection; trilingual version EN 45004:1995 Original language: de/en/fr, 61,20 EURtranslation: en, 106,10 EUR
189	DIN EN 45011, Publication date:1998-03 General requirements for bodies operating product certification systems (ISO/IEC Guide 65:1996); Trilingual version EN 45011:1998
190	DIN EN 45012, Publication date:1998-03 General requirements for bodies operating assessment and certification/registration of quality systems (ISO/IEC Guide 62:1996); Trilingual version EN 45012:1998
191	DIN EN 45013, Publication date:1990-05 General criteria for certification bodies operating certification of personnel; EN 45013:1989
192	DIN EN 45014, Publication date:1998-03 General criteria for supplier's declaration of conformity (ISO/IEC Guide 22:1996); Trilingual version EN 45014:1998
193	DIN EN ISO 9000, Publication date:2000-12 Quality management systems - Fundamentals and vocabulary (ISO 9000:2000); Trilingual version EN ISO 9000:2000
194	DIN EN ISO 9001, Publication date:2000-12 Quality management systems - Requirements (ISO 9001:2000); Trilingual version EN ISO 9001:2000
195	DIN EN ISO 9004, Publication date:2000-12 Quality management systems - Guidelines for performance improvements (ISO 9004:2000); Trilingual version EN ISO 9004:2000
206	General Principles of Process Validation´, May 1987
207	Guide to Inspections of Cosmetic Product Manufacturers, February 1995
208	Guide to Inspections of Oral Solutions and Suspensions, August 1994
209	Guide to Inspections of Sterile Drug Substance Manufacturers, July 1994
210	Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation, January 1994
211	Guide to Inspections of Dosage Form Drug Manufacturers, October 1993
212	Guide to Inspections of Validation of Cleaning Processes, July 1993
213	Guide to Inspections of Pharmaceutical Quality Control Laboratories, July 1993
214	Guide to Inspections of High Purity Water Systems, July 1993
215	Guide to Inspections of Lyophilisation of Parenterals, July 1993
216	Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, July 1993
217	Guide to Inspections of Topical Drug Products, July 1994
218	Sterilization Process Validation, January 1993
220	Guide to Inspections of Foreign Pharmaceutical Manufacturers, (5/96)
221	Biotechnology Inspection Guide, November 1991
222	Mid Atlantic Region Pharmaceutical Inspection Programme - Inspection Guidance for Prescription Drug Plants, January 1990
223	Compliance Policy Guides - Enforcement Policy: 21 CFR Part 11, Electronic Records; Electronic Signatures (CPG 7153.17)
257	Biological Testing of Medicinal and Dental Materials and Devices Part 1: Guidance on Selection Tests
258	Medizinproduktegesetz
259	Validation for Medical Devices and Diagnostic Manufacturers
261	Evaluation, Validation and Implementation of New Microbiological Testing Methods
262	PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S 1/95(Rev.4)) November 2007
267	Principles of Qualification and Validation in Pharmaceutical Manufacture
268	Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures: Electronic Copies of Electronic Records
269	Note for Guidance on Process Validation
270	ISO 13683 Sterilization of health care products
271	Medical devices -- Application of risk management to medical devices - Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte
273	Quality systems Medical devices - Particular requirements for the application of ISO 9001
276	FIP Guidelines for Dissolution Testing of Solid Oral Products.
279	Guidance for Industry Analytical Procedures and Methods Validation; Chemistry, Manufacturing, and Controls Documentation
280	Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures: Time Stamps
281	Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures: Maintenance of Electronic Records
283	Note for Guidance on Start of Shelf-Life of the Finished Dosage Form
284	Note for Guidance on Quality of Herbal Medicinal Products
285	Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products
286	Note for Guidance on Medicinal Gases: Pharmaceutical Documentation
287	Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products
288	Note for Guidance on Quality of Water for Pharmaceutical Use (Rev.)
290	Note 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
292	Note for Guidance on the Investigation of Bioavailability and Bioequivalence
293	Note for Guidance on Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances
295	Note for Guidance on Stability Testing of Existing Active Substances and Related Finished Products
298	Note for Guidance on Impurities: Residual Solvents - Permissible Daily Exposure for Tetrahydrofuran and N-Methylpyrrolidone
299	Note for Guidance on Impurities in New Drug Products
319	Certificate of Pharmaceutical Product - Application Instructions -
322	Standard Abbreviations (Acronyms)
324	Proposed Changes to the CGMP Regulations 21 CFR Part 210 and 211 (proposed rule)
325	Preamble to Title 21, Subchapter C, Human and Veterinary Drugs, Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding
326	21 CFR Part 800
327	21 CFR Part 820 (Quality System Regulation)
328	21 CFR Part 7 Enforcement Policy
329	21 CFR Part 600 Biological Products: General
330	21 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components
331	21 CFR Part 610 General Biological Products Standards
332	21 CFR Part 314 Applications for FDA approval to market a new drug
333	21 CFR Part 314.81 Other Postmarketing Reports (including Annual Report)
334	21 CFR Part 312 Investigational New Drug Application
340	Glossary of Computerized System and Software Development Terminology
342	Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices
343	REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
344	Guide to Inspections of Medical Device Manufacturers (12/97)
358	Guide to Inspections of Foreign Medical Device Manufacturers (9/95)
360	Investigations Operations Manual