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Nr.	Title
4	Submitting Samples and Analytical Data for Methods Validation
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
12	Changes to an Approved NDA or ANDA, Revision 1
15	PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites, April 1998
16	SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum
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
27	Impurities in New Drug Substances
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
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
56	BACPAC I: (withdrawn) Intermediates in Drug Substance Synthesis, Bulk Actives Post-approval Changes: Chemistry, Manufacturing and Controls Documentation
78	Manufacturing, Processing Or Holding of Active Pharmaceutical Ingredients (APIs), March 1998
79	Computerized Systems used in clinical trials-Draft
80	Drug Master Files, September 1989
84	Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
102	Explanatory Note for Industry on the Preparation of a Site Master File (PE 008-4) Jan 2011
108	Aseptic processing of health care products- Part 1: General requirements
109	Validation of Aseptic Processing (PI 007-6) 2011
110	Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations
111	Validation of Computer-related Systems TR 18
113	Validation and Qualification of Computerized Laboratory Data Acquisition Systems
114	GAMP Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach
115	21 CFR Part 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 November 2008
121	Annex 2: Manufacture of Biological Medicinal Products for Human Use
122	Annex 3: Manufacture of Radiopharmaceuticals (Revision September 2008)
124	Annex 5: Manufacture of Immunological Veterinary Medicinal Products
125	Annex 6: Manufacture of Medicinal Gases
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
131	Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products
138	Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
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
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)
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
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
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
257	Biological Testing of Medicinal and Dental Materials and Devices Part 1: Guidance on Selection Tests
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
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
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
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	Guideline on the Investigation of Bioequivalence
319	Certificate of Pharmaceutical Product - Application Instructions -
322	Standard Abbreviations (Acronyms)
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 Medical Devices - General
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
344	Guide to Inspections of Medical Device Manufacturers (12/97)
358	Guide to Inspections of Foreign Medical Device Manufacturers (9/95)
378	Guide to International Inspections and Travel
379	Compliance Program Manual
380	Medical Device Reporting: An Overview
381	Compliance Program Guidance Manual 7348.808 Good Laboratory Practice (02/2001)
382	Compliance Program Guidance Manual 7356.002 Drug Manufacturing Insections (02/2002)
383	ISPE Good practice Guide Commissioning and Qualification of Pharmaceutical Water and Steam Systems
387	Guide to Inspections of Quality Systems (08/99)
388	Q 9: ICH Draft Consensus Guideline: Q9 Quality Risk Management
467	DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS
468	"Do It By Design: An Introduction to Human Factors in Medical Devices"
470	Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System Regulation
471	General Principles of Software Validation; Final Guidance for Industry and FDA Staff
479	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: 20/01/2011).
481	Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation
482	2001/20/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
485	Guide to Bioresearch Monitoring Inspections of in vitro Diagnostic Devices
490	Alternative to Certain Prescription Device Labeling Requirements
492	Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems
494	Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Final Guidance for Industry and FDA
495	Inspections of Medical Device Manufacturers
496	Guide to Inspections of Infectious Disease Marker Testing Facilities
497	Third Party Review; An Instruction Manual For Conducting Reviews of Premarket Notifications
501	Medical Device Reporting for Manufacturers
502	In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
510	Environmental Assessment of Human Drug and Biologics Applications
511	Format and Content of the Chemistry, Manufacturing and Controls Section of an Application
518	SUPAC-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
519	SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In-Vitro Release Testing and In Vivo Bioequivalence Documentation
522	Submission of Chemistry, Manufacturing and Controls Information for Synthetic Peptide Substances
523	Submitting Documentation for the Manufacture of and Controls for Drug Products
526	Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
528	SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum
529	Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Issued 7/1997, Posted 7/28/1997)
530	Container Closure Systems for Packaging Human Drugs and Biologics
531	Submitting Documentation for the Stability of Human Drugs and Biologics
538	Monoclonal Antibodies Used as Reagents in Drug Manufacturing (Issued 3/2001, Posted 3/28/2001)
545	Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products (Issued 5/1999, Posted 6/2/1999)
559	ANDA's: Impurities in Drug Substances
564	ANDAs: Impurities in Drug Products
566	Q1A(R2)Stability Testing of New Drug Substances and Products
567	Q1B Photostability Testing of New Drug Substances and Products
569	Q2A Validation of Analytical Procedures
570	Q2B Validation of Analytical Procedures: Methodology
571	Q3A Impurities in New Drug Substances, Revision 2
572	Q3B(R) Impurities in New Drug Products
573	Q3C Impurities: Residual Solvents
574	Q3C Tables and List
575	Q3C Impurities: Residual Solvents Appendix 4
578	Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
579	Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
581	Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability
582	Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
583	Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products
584	Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
649	EC-USA MRA, Sectoral Annex on Good Manufacturing Practices (GMP)
650	Japanese Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processong
652	Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs
654	Questions and Answers regarding "Guideline on Management of Computerized Systems for Marketing Authorisation Holders and Manufacturers of Drugs and Quasi-drugs
706	Eudralex Volume 2B - Medicinal products for human use - Presentation and content of the dossier - Common Technical Document (CTD)
711	Compilation of Community Procedures on Inspections and Exchange of Information
712	Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents
753	Chapter 1 - Marketing Authorisation (updated version - November 2005)
754	Chapter 2 - Mutual Recognition (updated version - February 2007)
755	Chapter 3 - Community Referral (updated version - September 2007)
756	Chapter 4 - Centralised Procedure (updated version - April 2006)
757	Chapter 5 - Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 as well as on the documentation to be submitted pursuant to these procedures. - (February 2010)
758	Chapter 6 - Community Marketing Authorisation (updated version - November 2005)
759	Chapter 7 - General Information (revision July 2008)
778	Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (October 2003)
779	Guideline on the processing of renewals in the centralised procedure (October 2005)
780	Application form for renewal of a marketing authorisation and guidance for the completion of the application form (February 2007)
781	Guidance concerning consultation with target patient groups for the package leaflet
782	Guideline on fast track procedure for human influenza vaccines