current Global Automated Regulatory Database (cGARD) becomes a true Regulatory Intelligence Portal

ComplianceControl cGARD [regulations]

ComplianceControl cGARD [compliance subjects]

• Single source of regulatory data
• Available online - always up to date, no installation needed
• Secure db technology - Oracle
• Regulations categorised - ability to limit searches to industry-defined compliance subjects
• Draft regulations
• Validation Documentation Templates - FS, HATS, HDS, IQ, OQ, PQ, DQ Risk Assessment, Code Review, SDS, URS, Validation Plan, Validation Report
• Change Matrix - history and details of all changes to regulations covered in the tool
• Advanced keyword, keywords or phrase search facility, including bookmarking
• Glossary database of regulatory, pharmaceutical and life-science terminology
• Full reporting and print capability - Export of data to industry recognised file format (.doc or .pdf)
• Regulatory assessment reports
• Links to global regulatory agencies
• Search of FDA Warning Letters
• View news from trusted sources within the industry including, but not limited to, press releases, recalls information and enforcement reports from fda.gov.
• Ability to add personalised content to cGARD, like ISOs, copyrighted guidelines, company corporate standards, SOPs, QMS etc. – function enabled only in a corporate version of cGARD

ComplianceControl cGARD [report]

ComplianceControl cGARD regulatory standards include:

• 21 CFR Part 1 – General enforcement regulations
• 21 CFR Part 2 – General Administration Rulings and Decisions
• 21 CFR Part 3 – Product jurisdiction
• 21 CFR Part 5 – Organisation
• 21 CFR Part 7 – Enforcement policy
• 21 CFR Part 10 - Administrative Practices and Procedures - Revised as of April 1, 2007
• 21 CFR Part 11 (US ERES) – Electronic Records; Electronic Signatures
• 21 CFR Part 12 - Formal Evidentiary Public Hearing - Revised as of April 1, 2008
• 21 CFR Part 13 - Public Hearing Before a Public Board Of Inquiry - Revised as of April 1, 2008
• 21 CFR Part 14 - Public Hearing Before a Public Advisory Committee - Revised as of April 1, 2008
• 21 CFR Part 15 - Public Hearing Before the Commissioner - Revised as of April 1, 2008
• 21 CFR Part 16 - Regulatory Hearing Before the Food and Drug Administration - Revised as of April 1, 2008
• 21 CFR Part 17 - Civil Money Penalties Hearings - Revised as of April 1, 2008
• 21CFR Part 19 - Standards of Conduct and Conflicts of Interest - Revised as of April 1, 2007
• 21CFR Part 20 - Public Information - Revised as of April 1, 2007
• 21 CFR Part 21 - Protection of Privacy - Revised as of April 1, 2007
• 21 CFR Part 25 - Environmental Impact Considerations - Revised as of April 1, 2007
• 21 CFR Part 26 - 21st Code of Federal Regulations Part 26 - Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and certain Medical Device Product Evaluation Reports: UNITED STATES and the EUROPEAN COMMUNITY - 1st April 2007
• 21 CFR Part 50 (US GCP) – Protection of human subjects
• 21 CFR Part 54 (US GCP) – Disclosure by clinical investigations
• 21 CFR Part 56 (US GCP) – Institutional review boards
• 21 CFR Part 58 (US GLP) – Good laboratory practice for non-clinical laboratory studies
• 21 CFR Part 60 - Patient Term Restoration - Revised as of April 1, 2007
• 21 CFR Part 70 - Color Additives - Revised as of April 1, 2007
• 21 CFR Part 71 - Color Additive Petitions - Revised as of April 1, 2007
• 21 CFR Part 73 - Listing of Color Additives Exempt From Certification - Revised as of April 1, 2007
• 21 CFR Part 74 - Listing of Color Additives Subject to Certification - Revised as of April 1, 2007
• 21 CFR Part 80 - Color Additive Certification - Revised as of April 1, 2007
• 21 CFR Part 81 - General Specifications and General Restrictions for Provisional Color Additives for use in Foods, Drugs, And Cosmetics - Revised as of April 1, 2007
• 21 CFR Part 82 - Listing of Certified Provisionally Listed Colors and Specifications - Revised as of April 1, 2007
• 21 CFR Part 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices - Revised as of April 1, 2007
• 21 CFR Part 110 – current good manufacturing practice in manufacturing, packing, or holding human food
• 21 CFR Part 111 - 21st Code of Federal Regulations Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
• 21 CFR Part 200 – General
• 21 CFR Part 201 - Labeling - Revised as of April 1, 2007
• 21 CFR Part 202 - Prescription Drug Advertising - Revised as of April 1, 2007
• 21 CFR Part 203 (US PDMA) – Prescription drug marketing
• 21 CFR Part 205 - 21st Code of Federal Regulations Part 205 - Guidelines for State licensing of wholesale prescription drug distributors
• 21 CFR Part 208 - 21st Code of Federal Regulations Part 208 - Medication Guides for prescription drug products
• 21 CFR Part 210 (US GMP) – Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general
• 21 CFR Part 211 (US GMP) – Current good manufacturing practice for finished pharmaceuticals
• 21 CFR Part 207 - Regristration of Producers of Drugs and Listing of Drugs in Commercial Distribution - Revised as of April 1, 2007
• 21 CFR Part 216 - 21st Code of Federal Regulations Part 216 - Pharmacy compounding
• 21 CFR Part 225 - 21st Code of Federal Regulations Part 225 - Current good manufacturing practice for medicated feeds
• 21 CFR Part 226 – current good manufacturing practice for type a medicated articles
• 21 CFR Part 250 - Special Requirements for Specific Human Drugs - Revised as of April 1, 2007
• 21 CFR Part 290 - Controlled Drugs - Revised as of April 1, 2007
• 21 CFR Part 299 - Drugs; Official Names and Established Names - Revised as of April 1, 2007
• 21 CFR Part 300 - General - Revised as of April 1, 2007
• 21 CFR Part 310 - New Drugs - Revised as of April 1, 2007
• 21 CFR Part 312 (US GCP) – Investigational new drug application
• 21 CFR Part 314 (US GCP) – Applications for FDA approval to market a new drug
• 21 CFR Part 315 - Diagnostic Radiopharmaceuticals - Revised as of April 1, 2007
• 21 CFR Part 316 - Orphan Drugs - Revised as of April 1, 2007
• 21 CFR Part 320 - 21st Code of Federal Regulations Part 320 - Bioavailability and bioequivalence requirements
• 21 CFR Part 328 - 21st Code of Federal Regulations Part 328 - Over-the-counter drug products intended for oral ingestion that contain alcohol
• 21 CFR Part 330 - 21st Code of Federal Regulations Part 330 - Over-the-counter (OTC) human drugs which are generally recognized as safe and effective and not misbranded
• 21 CFR Part 331 - 21st Code of Federal Regulations Part 331 - Antacid products for over-the-counter (OTC) human use
• 21 CFR Part 332 - 21st Code of Federal Regulations Part 332 - Antiflatulent products for over-the-counter human use
• 21 CFR Part 336 - 21st Code of Federal Regulations Part 336 - Antiemetic drug products for over-the-counter human use
• 21 CFR Part 338 - 21st Code of Federal Regulations Part 338 - Nighttime sleep-aid drug products for over-the-counter human use
• 21 CFR Part 340 - 21st Code of Federal Regulations Part 340 - Stimulant drug products for over-the-counter human use
• 21 CFR Part 341 - 21st Code of Federal Regulations Part 341 - Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use
• 21 CFR Part 343 - 21st Code of Federal Regulations Part 343 - Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use
• 21 CFR Part 344 - 21st Code of Federal Regulations Part 344 - Topical OTIC drug products for over-the-counter human use
• 21 CFR Part 346 - 21st Code of Federal Regulations Part 346 - Anorectal drug products for over-the-counter human use
• 21 CFR Part 347 - 21st Code of Federal Regulations Part 347 - Skin protectant drug products for over-the-counter human use
• 21 CFR Part 348 - 21st Code of Federal Regulations Part 348 - External analgesic drug products for over-the-counter human use
• 21 CFR Part 349 - 21st Code of Federal Regulations Part 349 - Ophthalmic drug products for over-the-counter human use
• 21 CFR Part 352 - 21st Code of Federal Regulations Part 352 - Sunscreen drug products for over-the-counter human use
• 21 CFR Part 355 - 21st Code of Federal Regulations Part 355 - Anticaries drug products for over-the-counter human use
• 21 CFR Part 357 - 21st Code of Federal Regulations Part 357 - Miscellaneous internal drug products for over-the-counter human use
• 21 CFR Part 358 - 21st Code of Federal Regulations Part 358 - Miscellaneous external drug products for over-the-counter human use
• 21 CFR Part 361 - 21st Code of Federal Regulations Part 361 - Prescription drugs for human use generally recognized as safe and effective and not misbranded: Drugs used in research
• 21 CFR Part 369 - 21st Code of Federal Regulations Part 369 - Interpretative statements re warnings on drugs and devices for over-the-counter sale
• 21 CFR Part 600 (US Biologics) – Biological products – General
• 21 CFR Part 601 (US Biologics) – Licensing
• 21 CFR Part 606 – current good manufacturing practice for blood and blood components
• 21 CFR Part 607 - Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products - Revised as of April 1, 2008
• 21 CFR Part 610 (US Biologics) – General biological products standards
• 21 CFR Part 630 - General Requirements for Blood, Blood Components and Blood Derivatives - Revised as of April 1, 2008
• 21 CFR Part 640 - Additional Standards for Human Blood and Blood Products - Revised as of April 1, 2008
• 21 CFR Part 660 - Additional Standards for Diagnostic Substances for Laboratory Tests - Revised as of April 1, 2008
• 21 CFR Part 680 - Additional Standards for Miscellaneous Products - Revised as of April 1, 2008
• 21 CFR Part 700 - Cosmetics General - Revised as of April 1, 2008
• 21 CFR Part 701 - Cosmetic Labeling - Revised as of April 1, 2008
• 21 CFR Part 710 - Voluntary Registration of Cosmetic Product Estalishments - Revised as of April 1, 2008
• 21 CFR Part 720 - Voluntary Filing of Cosmetic Product Ingredient Composition Statements - Revised as of April 1, 2008
• 21 CFR Part 740 - Cosmetic Product Warning Statements - Revised as of April 1, 2008
• 21 CFR Part 800 - General - Revised as of April 1, 2008
• 21 CFR Part 801 - Labeling - Revised as of April 1, 2008
• 21 CFR Part 803 - Medical Device Reporting - Revised as of April 1, 2008
• 21 CFR Part 806 - Medical Devices; Reports of Corrections and Removals - Revised as of April 1, 2008
• 21 CFR Part 807 – Establishment registration and device listing for manufacturing and initial importers of devices
• 21 CFR Part 808 - Exemptions from Federal Preemption of State And Local Medical Device Requirements - Revised as of April 1, 2008
• 21 CFR Part 809 - In Vitro Diagnostic Products for Human Use - Revised as of April 1, 2008
• 21 CFR Part 810 - Medical Device Recall Authority - Revised as of April 1, 2008
• 21 CFR Part 812 (US Devices) – Investigational device exemptions
• 21 CFR Part 814 (US Devices) – Pre-market approval of medical devices
• 21 CFR Part 820 (US QSR) – Quality system regulation
• 21 CFR Part 860 - Medical Device Classification Procedures - Revised as of April 1, 2008
• 21 CFR Part 861 – Procedures for performance standards development
• 21 CFR Part 862 - Clinical chemistry and clinical toxicology devices - Revised as of April 1, 2008
• 21 CFR Part 868 - Anesthesiology devices - Revised as of April 1, 2008
• 21 CFR Part 870 - Cardiovascular devices - Revised as of April 1, 2008
• 21 CFR Part 874 - Ear, nose, and throat devices - Revised as of April 1, 2008
• 21 CFR Part 876 - Gastroenterology-urology devices - Revised as of April 1, 2008
• 21 CFR Part 878 - General and plastic surgery devices - Revised as of April 1, 2008
• 21 CFR Part 880 - General hospital and personal use devices - Revised as of April 1, 2008
• 21 CFR Part 895 - Banned Devices - Revised as of April 1, 2007
• 21 CFR Part 1270 - Human Tissue Intended for Transplantation - Revised as of April 1, 2008
• 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products - Revised as of April 1, 2008
• 21 CFR Part 1300 - Definitions - Revised as of April 1, 2008
• 21 CFR Part 1301 - Registration of manufacturers, distributors, and dispensers of controlled substances - Revised as of April 1, 2008
• 21 CFR Part 1302 - Labeling and packaging requirements for controlled substances - Revised as of April 1, 2008
• 21 CFR Part 1303 - Quotas - Revised as of April 1, 2008
• 21 CFR Part 1304 - Records and reports of registrants - Revised as of April 1, 2008
• 21 CFR Part 1305 - Orders for schedule I and II controlled substances - Revised as of April 1, 2008
• 21 CFR Part 1306 - Prescriptions - Revised as of April 1, 2008
• 21 CFR Part 1307 - Miscellaneous - Revised as of April 1, 2008
• 21 CFR Part 1308 - Schedules of controlled substances - Revised as of April 1, 2008
• 21 CFR Part 1309 - Registration of manufacturers, distributors, importers and exporters of List I chemicals - Revised as of April 1, 2008
• 21 CFR Part 1310 - Records and reports of listed chemicals and certain machines - Revised as of April 1, 2008
• 21 CFR Part 1311 - Digital certificates - Revised as of April 1, 2008
• 21 CFR Part 1312 - Importation and exportation of controlled substances - Revised as of April 1, 2008
• 21 CFR Part 1313 - Importation and exportation of List I and List II chemicals - Revised as of April 1, 2008
• 21 CFR Part 1314 - Retail sale of scheduled listed chemical products - Revised as of April 1, 2008
• 21 CFR Part 1315 - Importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine - Revised as of April 1, 2008
• 21 CFR Part 1316 - Administrative functions, practices, and procedures - Revised as of April 1, 2008
• 21 CFR Part 1401 - Public Availability of information - Revised as of April 1, 2007
• 21 CFR Part 1402 - Mandatory declassification review - Revised as of April 1, 2007
• 21 CFR Part 1403 - Uniform administrative requirements for grants and cooperative agreements to state and local governments - Revised as of April 1, 2007
• 21 CFR Part 1404 - Governmentwide debarment and suspension (Nonprocurement) - Revised as of April 1, 2007
• 21 CFR Part 1405 - Governmentwide requirements for drug-free workplace (Financial Assistance) - Revised as of April 1, 2007
• Sarbanes Oxley Act 2002

• GDP 94/C 63/03 – Guidelines on Good Distribution Practice of Medicinal Products for Human Use
• EU Directive 178/2002 – Directive laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
• EU Directive 1935/2004 – materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC
• Directive 89/105/EEC - Relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems
• EU Directive 91/412/EEC – Laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
• EU Directive 93/42/EEC – 14 June 1993 concerning medical devices
• EU Directive 98/79/EC - in vitro diagnostic medical devices
• EU Directive 1999/93/EC – Community framework for electronic signatures
• EU Directive 2001/20/EC – Implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
• EU Directive 2001/83/EC – Community code relating to medicinal products for human use
• EU Directive 2001/95/EC – General Product Safety
• EU Directive 2002/95/EC – Restrictions of the use of hazardous substances in electrical and electronic equipment
• EU Directive 2002/96/EC – Where a computerised system replaces a manual operation
• EU Directive 2002/98/EC – Amending Directive 2001/83/EC
• EU Directive 2003/63/EC – Amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
• EU Directive 2003/94/EC – Laying down principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
• EU Directive 2004/23/EC – Standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
• EU Directive 2004/24/EC – Amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
• EU Directive 2004/27/EC – Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance)
• EU Directive 2005/28EC – principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use
• Directive 2007/47/EC - Amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive 2008/29/EC - Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission
• Eudralex Volume 4: Part 1 – Basic Requirements for Medicinal Products

• Chapter 1 – Quality Management
• Chapter 2 – Personnel
• Chapter 3 – Premise and Equipment
• Chapter 4 – Documentation
• Chapter 5 – Production
• Chapter 6 – Quality Control
• Chapter 7 – Contract Manufacturing and Analysis
• Chapter 8 – Complaints and Product Recall
• Chapter 9 – Self Inspection

• Eudralex Volume 4: Part 2 – Basic Requirements for Active Substances used as Starting Materials
• Annex 1 – Manufacture of Sterile Medicinal Products
• 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
• 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
• Annex 14 – Manufacture of Products derived from Human Blood or Human Plasma
• Annex 15 – Qualification and validation
• Annex 16 – Certification by a Qualified person and Batch Release
• Annex 17 – Parametric Release
• Annex 19 – Reference and Retention Samples (EU Directive 2003/94/EC / EU Directive 91/412/EEC )
• Annex 20 - Quality Risk Management
• Eudralex Volume 9A - Eudralex Volume 9A of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Human Use
• Eudralex Volume 9B - Eudralex Volume 9B of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance of Veterinary Medicinal Products

• S.I. 2005-2753 - Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 - October 2005
• S.I. 2005-2753 - Explanatory Note - October 2005
• S.I. 2005-2753 (Schedule 5) - Procedural Provisions Relating to the Grant Renewal, Variation, Revocation and Suspension of Certificates of Registration - October 2005
• S.I. 2005-2753 (Schedule 6) - Offences, Penalties etc. - October 2005
• S.I. 2005-2753 (Schedule 7) - Transitional Provisions - October 2005
• S.I. 2005-2753 (Schedule) - Consequential Amendments of the Act and Other Regulations - October 2005
• S.I. 2005/2789 - The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005
• S.I. 2005/2789 (Schedule 1) – STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER’S LICENCE RELATING TO THE MANUFACTURE AND ASSEMBLY OF RELEVANT MEDICINAL PRODUCTS
• S.I. 2005/2789 (Schedule 2) - STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER’S LICENCE RELATING TO THE IMPORT OF RELEVANT MEDICINAL PRODUCTS FROM A THIRD COUNTRY
• S.I. 2005/2789 (Schedule 3) - STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER’S LICENCE WHICH RELATES TO VACCINES, TOXINS OR SERA
• S.I. 2005/2789 (Schedule 4) - STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A WHOLESALE DEALER’S LICENCE
• S.I. 2005/2789 (Schedule 5) - CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS
• S.I. 2005/2789 (Schedule 6) - TRANSITIONAL PROVISIONS

• Japanese Ministry of Health, Labour and Welfare Guideline on Control of Computerized Systems in Drug Manufacturing
• Pharmaceutical Administration and Regulations in Japan English Regulatory Information Task Force, Japan, Pharmaceutical Manufacturers Association - March 2006

• Polish Pharmaceutical Law - Polish Pharmaceutical Law - Legal status valid 5th July 2006

• Canadian Health Products and Food Branch Inspectorate GMP Guidelines 2002 Edition Version 2
• Canadian Health Products and Food Branch Inspectorate Annex 2 to GMP Guidelines 2002 Edition Version 2 – ‘Manufacture of Drugs Used in Clinical Trials’
• SOR/98-282 - Medical Devices Regulations

• Drug Administration Law of the Peoples Republic of China
• Regulations for Implementation of the Drug Administration Law of the Peoples Republic of China
• Regulations for Supervision and Administration of Medical Devices
• Regulations on Administrative Protection for Pharmaceuticals

• OECD ENV/MC/CHEM(98)17 ‘The Application of the Principles of GLP to Computerised Systems’ – issued 26/01/1998
• ICH E1 - The Extent of Population Exposure to Assess Clinical Safety
• ICH E10 - Choice of Control Group in Clinical Trials
• ICH E2A – Clinical Safety Data Management
• ICH E2B Q&A(R5) - (ver.1.1) March 2005
• ICH E2B(R3) - REVISION of the Clinical Safety Data Management
• ICH E2C(R1) - Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
• ICH E2D - Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
• ICH E2E - Pharmacovigilance Planning
• ICH E3 - Structure and Content of Clinical Study Reports
• ICH E4 - Dose-Response Information to Support Drug Registration
• ICH E5 Q&A(R1) - June 2006
• ICH E5(R1) - Ethnic Factors in the Acceptability of Foreign Clinical Data
• ICH E6(R1) – Guidelines for Good Clinical Practice
• ICH E7 - Studies in support of Special Populations: Geriatrics
• ICH E8 - General Considerations for Clinical Trials
• ICH E9 - Statistical Principles for Clinical Trials
• ICH E11 - Clinical Investigation of Medicinal Products in the Pediatric Population
• ICH E12A - Principles for Clinical Evaluation of New Antihypertensive Drugs
• ICH E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
• ICH E14 Q and A: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs - 4th June 2008
• ICH E15 - Terminology in Pharmacogenomics
• ICH M1 – MedDRA – Medical Terminology
• ICH M2(R2) – Electronic Transmission of Individual Case Safety Reports Message Specification
• ICH M3(R1) - Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
• ICH M4(R3) - Organisation Of The Common Technical Document For The Registration Of Pharmaceuticals For Human Use
• ICH M4E(R1) - The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Efficacy
• ICH M4Q(R1) - The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Quality
• ICH M4S(R2) - The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Safety
• ICH M5 - Data Elements And Standards For Drug Dictionaries
• ICH Q1A(R2) - Stability Testing of New Drug Substances and Products
• ICH Q1B - Stability Testing : Photostability Testing of New Drug Substances and Products
• ICH Q1C - Stability Testing for New Dosage Forms
• ICH Q1D - Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
• ICH Q1E - Evaluation of Stability Data
• ICH Q1F - Stability Data Package for Registration Applications in Climatic Zones III and IV
• ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology
• ICH Q3A(R1) – impurities in new drug substances
• ICH Q3B(R2) – impurities in new drug products
• ICH Q3C(R3) – impurities: guideline for residual solvents
• ICH Q4 – Pharmacopoeias
• ICH Q4A - Pharmacopoeial Harmonisation
• ICH Q4B - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
• ICH Q4B (Annex 1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter
• ICH Q4B Annex 2: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter
• ICH Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter
• ICH Q4B (Annex 4A): Evaluation and Recommendation of Pharmacopoeial Texts for use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumerations Tests General Chapter - November 2008
• ICH Q4B (Annex 4B): Evaluation and Recommendation of Pharmacopoeial Texts for use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms General Chapter - November 2008
• ICH Q4B (Annex 4C): Evaluation and Recommendation of Pharmacopoeial Texts for the use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter - November 2008
• ICH Q5A(R1) – Viral Safety Evaluation Of BioTechnology Products Derived From Cell Lines Of Human Or Animal Origin
• ICH Q5B – Quality Of BioTechnical Products
• ICH Q5C – Stability testing Of BioTechnological/Biological Products
• ICH Q5D – Production Of BioTechnological/Biological Products
• ICH Q5E – Comparability Of BioTechnological/Biological Products Subject To Changes In Their Manufacturing Process
• ICH Q6A – test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
• ICH Q6A (Decision Trees)
• ICH Q6B – test procedures and acceptance criteria for biotechnological/biological products
• ICH Q7 – Good Manufacturing Guide For Active Pharmaceutical Ingredients – 10 November 2000
• ICH Q8 – Pharmaceutical Development
• ICH Q9 – quality risk management
• ICH Q10 - Pharmaceutical Quality System
• ICH S1A - Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
• ICH S1B - Testing for Carcinogenicity of Pharmaceuticals
• ICH S1C(R1) - Dose Selection for Carcinogenicity Studies of Pharmaceuticals
• ICH S2A - Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
• ICH S2B - Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals
• ICH S3A - Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
• ICH S3B - Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
• ICH S4 - Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent)
• ICH S5(R2) - Detection of Toxicity to Reproduction for Medicinal Products
• ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
• ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals
• ICH S7B - The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization
• ICH S8: Immunotoxicity Studies For Human Pharmaceuticals - September 2005

ComplianceControl cGARD - document repository includes:

• Eudralex Volume 4: Annex 1 (effective from 01 March 2009)
• Eudralex Volume 4: Annex 3 (effective from 01 March 2009)
• Eudralex Volume 4: Annex 7 (effective from 01 September 2009)
• Eudralex Volume 4 – Annex 11 (draft)
• ICH E2B(R3) (Step 2)
• ICH E2F – Development Safety Update Report
• ICH M3(R2) (Step 2)
• ICH M5 (Step 2)
• ICH Q4B Annex 5 (Step 2)
• ICH Q4B Annex 6 (Step 2)
• ICH Q4B Annex 7 (Step 2)
• ICH Q4B Annex 8 (Step 2)
• ICH Q8 Annex (Step 2)
• ICH S2(R1) (Step 2)
• ICH S9 – Nonclinical Evaluation for anticancer Pharmaceuticals

• Nuclear Pharmacy Guideline for Determining When to Register as a Drug Establishment (May 1984)
• Safe Use of Handling of Cytotoxic Drugs
• FDA - Compliance Policy Guides Manual (May 2002)
• Possible Dioxin/PCB Contamination of Drug and Biological Products (August 2000)
• Prescription Drug Marketing Act - Donation of Prescription Drug Samples to Free Clinics (March 2006)
• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (January 2006)
• PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (September 2004)
• CGMP for Phase 1 Investigational Drugs (July 2008)
• Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs (October 2007)
• Compressed Medical Gases Guideline (February 1989)
• Bar Code Label Requirements (October 2006)
• Testing of Glycerin for Diethylene Glycol (May 2007)
• Computerized Systems Used in Clinical Investigations (May 2007)
• Quality Systems Approach to Pharmaceutical CGMP Regulations (September 2006)
• The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP) (October 2007)
• Marketed Unapproved Drugs - Compliance Policy Guide (June 2006)
• A Review of FDA's Implementation of The Drug Export Amendments of 1986 (May 1990)
• Guideline For the Monitoring of Clinical Investigations (January 1988)
• Guideline on Validation of the Limulus Amebocyte Lysate Test (December 1987)
• Good Laboratory Practice Regulations - Questions and Answers (June 1981)
• Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (September 2004)
• Part 11, Electronic Records; Electronic Signatures - Scope and Application (August 2003)
• Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (October 2006)
• Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (June 1997)
• Cytotoxic Handling
• Guideline on the Preperation of Investigational New Drug Products (Human and Animal) (March 1991)
• Guideline On General Principles Of Process Validation (May 1987)