| Nr. | Title |
| |
| 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 |
| 121 | Annex 2: Manufacture of Biological Medicinal Products for Human Use |
| 122 | Annex 3: Manufacture of Radiopharmaceuticals |
| 125 | Annex 6: Manufacture of Medicinal Gases |
| 126 | Annex 7: Manufacture of Herbal Medicinal Products |
| 130 | Annex 11: Computerised Systems |
| 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 |
| 197 | Annex 1: Manufacture of Sterile Medicinal Products 09/1996 |
| 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 |
| 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.3)) November 2003 |
| 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 |
| 378 | Guide to International Inspections and Travel - Table of Contents |
| 379 | Compliance References: Program Guidance 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 | Compliance Program Guidance Manual 7382.845 Inspection of Medical Device Manufacturers (10/2000) |
| 387 | Guide to Inspections of Quality Systems (08/99) |
