Nr.	Titel
1576	WHO: Good Manufacturing Practices for Pharmaceutical Products: Main Principle
1577	Active pharmaceutical ingredients (bulk drug substances)
1578	Pharmaceutical excipients
1579	Sterile pharmaceutical products
1580	Biological products
1581	Investigational pharmaceutical products for clinical trials in humans
1582	Herbal medicinal products
1597	Guideline on Plastic Immediate Packaging Materials
1627	Inspektion von Qualifizierung und Validierung in pharmazeutischer Herstellung und Qualitätskontrolle
1629	Erstellen eines risiko- und zeitabhängigen Inspektionsplanes
1630	Ausstellung von Bescheinigungen nach § 73 Abs. 6 AMG (Zollbescheinigungen)
1631	Organisatorische Aspekte der Vorbereitung, Durchführung und Nachbereitung von GMP-Drittlandinspektionen
1632	Teambildung / Beteiligung von Sachverständigen
1633	Site Master File (SMF)
1634	Erstellung und Format von Inspektionsberichten
1635	Amtliche Entnahme von Proben nach § 65 AMG
1636	Vorgehensweise bei Arzneimittelrisiken, Verbraucherbeschwerden und sonstigen Beanstandungen
1637	Bewertung von Abweichungen, Fehlern und Mängeln
1638	Maßnahmen aufgrund von Fehlern und Mängeln
1639	Entscheidung über die Erteilung einer Herstellungserlaubnis gemäß § 13 AMG oder Einfuhrerlaubnis gemäß § 72 Absatz 1 AMG
1641	Ausstellung von Zertifikaten gemäß § 73a Abs. 2 AMG (WHO-Zertifikate)
1642	Information der Länder durch die ZLG-Website
1643	Austausch von Zertifikaten im Rahmen von Drittstaatenabkommen (MRA)
1644	Amtliche Untersuchung von Proben
1645	Umgang mit Ergebnissen: Bewertung und Bericht sowie Ergebnisse außerhalb der Spezifikation [OOS-(Out-of-Specification) Results]
1647	Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeial General Monograph "Substances for Pharmaceutical Use" and General Chapter" Control of Impurities in Substances for Pharmaceutical Use"
1650	Q1E Evaluation of Stability Data
1838	2002/98/EC - Directive 2002/98/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC
1839	2003/63/EC - COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
1849	Guideline on Vaccine Antigen Master File/ Plasma Master File (VAMF/PMF) (August 2004)
1850	Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7)
1851	Guideline on the procedure for VAMF certification
1852	Guideline on the procedure for PMF certification
1862	NOTICE TO APPLICANTS Volume 6B VETERINARY MEDICINAL PRODUCTS Presentation and content of the dossier
1865	Bioanalytical Method Validation (Issued 5/2991, Posted 5/22/2001)
1867	Bioavailability and Bioequivalence Studies for orally administered drug products - General considerations (Issued 3/2003, Posted 3/19/2003)
1868	Colestryramine Powder in Vitro Bioequivalence (Interim Guidance)
1869	Clozapine Tablets in Vivo Bioequivalence and in Vitro Dissolution Testing (Issued 06/17/2005, Reposted 06/17/2005)
1870	Corticosteroids, Dermatologic (topical) In Vivo (Issued 6/2/1995, Posted 3/6/1998)
1871	Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997, Posed 8/25/1997)
1872	Extended Release Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlation (Issued 9/1997, Posted 9/26/1997)
1873	Common Technical Document - Quality Questions and Answers/Location Issues
1874	CTD General Questions and Answers
1875	M4: Organization of the CTD
1877	GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD TRANSMISSIBLE INFECTIONS
1884	Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003)
1885	Metaproterenol Sulfate and Albuterol Metered Dose Inhalers in Vitro (Issued 6/27/1989, Posted 3/2/1998)
1887	Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing (Revised 6/6/1994, Posted 6/22/1998)
1888	Statistical Approaches to Establishing Bioequivalence (Issued 2/2001; Posted 2/1/2001)
1889	Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (Issued 8/2000, Poste 8/31/2000)
1890	Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/2003)
1892	Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide
1893	Conjugated Estrogens, USP-ÖC-MS-Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence (Issued 3/6/2000, Posted 3/6/2000)
1900	Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 8/2002, Posted 8/6/2002)
1902	Analytical Procedures and Methods Validation (Issued 8/2000, Posted 8/30(2000)
1903	Comparability Protocols - Chemistry, Manufacturing, and Controls Information (Issued 2/2003, Posted 2/20/2003)
1904	Drugs, Biologics, and Medical Devices Derived from Bioengineering Plants for Use in Humans and Animals (Posted 9/11/2003)
1905	Drug Product: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Poted 1/28/2003)
1906	Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Posted 1/28/2003)
1907	Interpreting Sameness of Monoclonal Antibody Products under the Orphan Drug Regulations (Issued 1/2004, Posted 1/6/2004)
1908	Liposome Drug Products: Chemistry, Manufacturing, and Controls: Human Pharmacokinetics, Bioavailability, and Labeling Documentation (Issued 7/2002, Posted 8/20/2002)
1935	Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
1941	APIC - List of Abbreviations & Acronyms
1942	APIC - Good manufacturing practices for Active ingredient manufacturers, with EFPIA, 1996
1943	APIC - Quality Management System for Active pharmaceutical Ingredient manufacturers - Integrating GMP into ISO 9001, December 1997
1944	APIC - Manufacture of sterile active pharmaceutical ingredients - guidance 1999
1945	APIC - Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants - Policy, 1999
1946	APIC - Good Manufacturing Practices in Active Pharmaceutical Ingredients Development, 1999
1947	APIC - Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, guidance 2000
1948	APIC - GMPs for APIs: “How to do” Document - Interpretation of the ICH Q7a Guide - Version 5: Final
1949	APIC - Computer validation Guide, December 2002
1950	APIC - Auditing Guide, September 2008
1951	Auditing Guide Appendix A – Secrecy Agreement
1952	Auditing Guide Appendix B – Pre-Audit Questionnaire
1953	Auditing Guide Appendix C – Aide Mémoire
1954	Auditing Guide Appendix D – Audit Report Template
1955	APIC - Parametric Release document, December 2002
1970	CPMP/QWP/450/03 corr Annexes to Specifications for class 1 and class 2 residual solvents in active substances (Adoped by CHMP July 2004)
1971	CHMP/QWP/297/97 Rev. 1 corr Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier
1972	CPMP/QWP/1529/04 CPMP Guideline on Control of Impurities of Pharmacopoeial Substances (Adopted for implementation, April 2004)
1973	CPMP/QWP/227/02 Rev 1 (EMEA/CVMP/134/02 Rev 1) Guideline on Active Substance Master File Procedure (February 2004)
1975	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.
1976	CPMP/QWP/130/96 Rev. 1 Note for guidance on Chemistry of the New Active Substance. (CPMP adopted December 2003)
1977	CPMP/QWP/122/02 Rev.1 Note for guidance on Stability Testing of Existing Active Substances and Related Finished products (Adoption by CPMP December 2003)
1978	CPMP/QWP/3309/01 (EMEA/CVMP/961/01) 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 (Adopted by CPMP/CVMP February 2003)
1979	CPMP/QWP/158/01 Revision (CVMP/115/01) Note For Guidance on Quality of Water for Pharmaceutical Use (Revision adopted by CPMP/CVMP May 02)
1980	CPMP/QWP/848/96 (EMEA/CVMP/598/99) Note for Guidance on Process Validation (CPMP/CVMP Adopted Feb. 01)
1981	CPMP/QWP/8567/99 Explanatory Note on the Operation of Two-Year Transition Period for Application of Note for Guidance on Residual Solvents to Marketed Products
1982	CPMP/QWP/576/96 Note for Guidance on Stability testing for a type II variation to a Marketing Authorisation (CPMP adopted April. 98)
1983	CPMP/QWP/576/96 - Rev 1 Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation
1985	CPMP/SWP/QWP/4446/00 Note for Guidance on Specification Limits for Residues of Metal Catalysts, (Re-released for consultation June 2002) Corrigendum
1986	Botanical Drug Products
1988	Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) APRIL 1996
1989	Development of new stereoisomeric drugs
1990	Drug Master Files for Bulk Antibiotic Drug Substances
1991	Drug Master Files, Current DMF Information
2002	Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (Issued 11/19/2004, Posted 11/19/2004)
2012	Corrigendum (Official Journal L 302, 20/11/2003 p. 40 DE).
2014	98/81/EC - Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Official Journal L 330, 5/12/1998 p. 13 - 31).
2015	2004/27/EC - Directive 2004/27/EC Amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136, 30/4/2004 p. 34 - 57).
2017	2003/94/EC - Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Official Journal L 262, 14/10/2003 p. 22 - 26).
2018	Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
2019	Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal L 345, 19/12/1998 P. 3 - 8 CONSLEG - 95R0297 - 19/12/1998 - 15 p.).
2020	Commission Regulation (EC) No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products
2021	COM/2003/839 Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted. [Update of the 1982 Commission Communication].
2022	Corrigendum to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal of the European Communities No L 35 of 15 February 1995)
2023	EC/726/2004- 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
2028	Gesetz über die Werbung auf dem Gebiet des Heilwesens
2032	Questions and Answers on Current Good Manufacturing (cGMP) for Drugs
2042	ANDAs: Pharmaceutical Solid Polymorphism
2047	Guidance for Industry Product Recalls, Including Removals and Corrections
2050	Verordnung über die Tierarzneimittel (Tierarzneimittelverordnung, TAMV) vom 18. August 2004 (Stand am 7. September 2004)
2051	Überwachung von Stoffen, die als Tierarzneimittel verwendet werden können (gemäß § 69a AMG)
2052	Aide Mémoire Bio- und Gentechnologie
2059	Annex 19: Reference and Retention Samples
2060	Q8(R2) Pharmaceutical Development
2070	APIC - Qualification of existing equipment (November 2004)
2071	APIC - Technical Change Control Guideline 2004 (October 2004)
2072	Recommendation on the Need for Revision of (CHMP) >Note for Guidance on Investigation of Bioavailability and Bioequivalence> CPMP/EWP/QWP/1401/98
2073	The APIC Audit Programme, January 2008
2075	Guideline on the Use of the CTD Format in the Preparation of a Registration Application for Traditional Medicinal Products
2076	Bioequivalence Recommendations for Specific Products
2081	Testing of Glycerin for Diethylene Glycol
2083	Concept Paper on Revision of the Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for new Submissions and Variations
2084	Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products
2085	Procedure for the Preparation of Community Monographs for Herbal Medicinal Products with Well-Established Use
2086	Procedure for Worksharing - Quality Variations
2096	Guidance for Industry, FDA Staff, and October 4, 2004 FDA, regulated industry, and Division of Small Third Parties; Implementation of the third parties, Manufacturers, Inspection by Accredited Persons International and Program Under the Medical Device User Consumer Assistance, Fee and Modernization Act of 2002;Accreditation Criteria
2103	Audit Language Requirements (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 1)
2104	MRA EG-Canada
2105	Sectoral annex for pharmaceutical good manufacturing practices (GMP) Joint Sectoral Committee Meeting / EC - U. S. MUTUAL RECOGNITION AGREEMENT : Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs) - Joint Summary (21/05/99)
2106	Council decision of of 8 October 2002 amending Decision 98/566/EC on the conclusion of an Agreement on mutual recognition between the European Community and Canada
2107	Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
2108	Council decision of of 8 October 2002 amending Decision 98/508/EC on the conclusion of an Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
2109	Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
2110	Council decision of of 8 October 2002 amending Decision 98/509/EC on the conclusion of an Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
2111	Council decision of of 8 October 2002 amending Decision 2001/747/EC concerning the conclusion of the Agreement on Mutual Recognition between the European Community and Japan
2112	Commission decision No 2/2002 of 8 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the modification of the Annex 1 of the Agreement
2113	Commission decision No 1/2003 of 28 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on Mutual Recognition in relation to Conformity Assessment on the establishment of the list of conformity assessment bodies recognised under the Agreement
2114	Corrigendum to Decision No 1/2003 (2003/128/EC) of 28 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the establishment of the list of conformity assessment bodies recognised under the Agreement
2134	Reflection paper on a proposed solution for dealing with minor deviations from the detail described in the Marketing Authorisation for Human and Veterinary Medicinal products (including biological products)
2137	Guidelines on active pharmaceutical ingredient master file procedure
2176	Q9 Quality Risk Management
2185	Arzneimittel-Zulassungsverordnung, AMZV 26. November 2002 Änderung vom 3. Juni 2002
2186	Arzneimittel-Zulassungsverordnung, AMZV 26. November 2002 Änderung vom 12. September 2002
2188	Heilmittel-Gebührenverordnung, HGebV vom 9. November 2001 Aenderung vom 12. September 2002
2200	Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
2222	Bar Code Label Requirements - Questions and Answers Posted: 6/7/2005, Publish Date: 6/7/2005
2224	Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
2231	Guidance Concerning the Braille Requirements for Labelling and the Package Leaflet
2232	Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
2233	Environmental Risk Assessment of Medicinal Products for Human Use
2238	Radiopharmaceutical products
2239	Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals
2242	WHO: Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
2246	Good trade and distribution practices for pharmaceutical starting materials
2247	WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation
2248	Certification scheme on the quality of pharmaceutical products moving in international commerce
2249	Procedure for assessing the acceptability, in principle, of procurement agencies for use by United Nations agencies
2250	Guidelines for the preparation of a procurement agency information file
2251	Interim guidelines for the assessment of a procurement agency
2252	Guide to good storage practices for pharmaceuticals
2253	Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
2254	Quality system requirements for national GMP inspectorates
2255	Pre-approval inspections
2256	Inspection of pharmaceutical manufacturers
2257	Inspection of drug distribution channels
2258	Guidance on GMP: Inspection Report
2259	Model Certificate of GMP
2260	Basic tests for drugs : pharmaceutical substances, medicinal plant materials and dosage forms
2261	The International Pharmacopoeia
2262	Index of national, regional and international pharmacopoeias
2263	Lists of available International Chemical Reference Substances and International Infrared Reference Spectra
2264	Recommendations on Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products
2265	The International Pharmacopoeia: revised concepts and future perspectives
2266	Orally Disintegrating Tablets
2267	Considerations for requesting analyses of drug samples
2268	Model certificate of analysis
2269	Good practices for pharmaceutical quality control laboratories
2270	Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
2271	Guidelines for preparing a laboratory information file
2272	Quality control methods for medicinal plant materials
2273	GAMP Good Practice Guide Electronic Data Archiving
2274	Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
2275	Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
2276	Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
2277	Guidelines on packaging for pharmaceutical products
2278	Guidelines on import procedures for pharmaceutical products
2279	Anforderungen an elektronische Unterschriften und Handzeichen
2280	Inspektionsverfahren bei genehmigungspflichtigen klinischen Prüfungen von Arzneimitteln
2281	Überprüfung der Qualifikation des Personals nach §§ 14, 52a, 63a, 72 Abs.2 und 74a AMG
2284	Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products
2285	Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
2287	Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
2289	HUMAN FACTORS PRINCIPLES FOR MEDICAL DEVICE LABELING
2298	Aide Memoire on GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS (PI 021-2) Sept 2007
2299	Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-2) Sept 2007
2300	Aide Memoire on Inspection of Quality Control Laboratories(PI 023-2) Sept 2007
2301	Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA
2302	Premarket Notifications [510(k)]for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers