| Nr. | Title |
| |
| 1438 | Good Practices for Computerised Systems in Regulated "GXP" Environments (PI 011-3) Sept 2007 |
| 1441 | Part 11, Electronic Records, Electronic Signatures: Scope and Application |
| 1449 | GAMP Good Practice Guide Validation of Process Controls Systems |
| 1450 | Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process |
| 1451 | Drug Approval Application Process |
| 1455 | Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV (Revision 1) |
| 1462 | Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin |
| 1463 | Guide to Good Manufacturing Practice for Medicinal Products (PE 009-7) Introduction (Sept 2007) |
| 1464 | PIC/S Guide to Inspections of Source Plasma Establishment and Plasma Warehouses (PI 008-3) Sept 2007 |
| 1465 | Site Master File for Source Plasma Establishments (PI 019-3) Sept 2007 |
| 1466 | Site Master File for Plasma Warehouses (PI 020-3) Sept 2007 |
| 1470 | Q4B Evaluation and Recommendation of Pharmacopoeila Texts for Use in the ICH Regions |
| 1475 | Accetability of Standards from Alternative Compendia (BP/EP/JP) |
| 1476 | Blood Establishment Computer Systems Validation in the User's Facility |
| 1477 | EC/1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Note: shall apply from 30 December 2008)(Official Journal L 324, 10/12/2007 p. 121 - 137). |
| 1478 | EC/658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 155, 15/6/2007 p. 10 - 19). |
| 1502 | The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP) |
| 1503 | GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS |
| 1504 | Section 1 |
| 1505 | Section 2 |
| 1506 | Section 3 |
| 1507 | 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 |
| 1508 | INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information |
| 1513 | Eudralex Volume 10 - Clinical Trials |
| 1518 | SPL Standard for Content of Labeling Technical Qs & A |
| 1519 | Part 11, Electronic Records, Electronic Signatures - Scope and Application |
| 1521 | Providing Regulatory Submissions in Electronic Format - General Considerations |
| 1522 | Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions using the eCTD Specifications |
| 1523 | Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Saftey Reports |
| 1524 | Providing Regulatory Submissions in Electronic Format - Postmarketing Periodic Adverse Drug Experience Reports |
| 1525 | Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling |
| 1529 | Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products |
| 1530 | CPMP/QWP/2054/03 Annex II to Note for Guidance on Process Validation CHMP/QWP/848/99 and EMEA CVMP/598/99 Non-Standard Processes (Adopted by CHMP July 2004) |
| 1533 | Position Paper on Specifications for Class 1 and Class 2 Residual Solvents in Active Substances |
| 1534 | Note for Guidance on Specification Limits for Residues of Metal Catalysts |
| 1535 | Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products |
| 1536 | Note for Guidance on Parametric Release |
| 1537 | Note for Guidance on Quality of Modified Release Products: A. Oral Dosage Forms; B. and Transdermal Dosage Forms; Section I (Quality) |
| 1568 | Explanatory Note ot the Operation of Two-Year Transition Period for Application of Note for Guidance on Residual Solvents to Marketed Products |
| 1570 | Note for Guidance on Manufacture of the Finished Dosage Form |
| 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 |
| 1596 | DIRECTIVE 2004/28/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products |
| 1597 | Guideline on Plastic Immediate Packaging Materials |
| 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 |
| 1837 | DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004
amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use |
| 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) |
| 1866 | Comparability Protocols - Protein Drug Products and Biological Products . Chemistry, Manufacturing, and Controls Information |
| 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 |
| 1876 | M4: The CTD — General Questions and Answers |
| 1877 | M4: The CTD — Quality Questions and Answers/Location Issues |
| 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) |
| 1894 | M4E: The CTD — Efficacy |
| 1896 | M4: The CTD — Efficacy Questions and Answers |
| 1897 | Bioequivalence Studies Data and Detailed Statistical Methodology (Posted 3/2/1998) |
| 1898 | M4S: The CTD — Safety |
| 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 - integrating GMP (ICH Q7a) into ISO (9001: 2000) |
| 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, 2000 |
| 1948 | APIC - GMPs for APIs: “How to do” Document Interpretation of the ICH Q7a Guide |
| 1949 | APIC - Computer validation Guide, December 2002 |
| 1950 | APIC - Auditing Guide, August 2002 |
| 1951 | Auditing Guide Appendix A –
Secrecy Agreement |
| 1952 | Auditing Guide Appendix B –
Customer Questionnaire |
| 1953 | Auditing Guide
Appendix C – Aide Mémoire |
| 1954 | Auditing Guide Appendix D –
Audit Report |
| 1955 | APIC - Parametric Release, 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) |
| 2011 | Consolidated Directive 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 as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC. |
| 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]. |
| 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 (Official Journal L 136, 30/4/2004 p. 1 - 33). |
| 2032 | Questions and Answers on Current Good Manufacturing (cGMP) for Drugs |
| 2039 | Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP |
| 2042 | ANDAs: Pharmaceutical Solid Polymorphism |
| 2047 | Guidance for Industry Product Recalls, Including Removals and Corrections |
| 2059 | Annex 19 Reference and Retention Samples |
| 2060 | Q8 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 | Questions & Answers on the Bioavailability and Bioequivalence Guideline |
| 2074 | 21 CFR Parts 210 and 211 Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals |
| 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 |
| 2097 | Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, June 1, 2004 |
| 2098 | Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria |
| 2099 | Medical Device Postmarket Vigilance and Surveillance: Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative |
| 2100 | Medical Device Postmarket Vigilance and Surveillance: Universal Data Set for Manufacturer Adverse Event Reports |
| 2101 | Medical Device Postmarket Vigilance and Surveillance: Timing of Adverse Event Reports |
| 2102 | Manufacturer's Trend Reporting of Adverse Events |
| 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 |
| 2115 | Update on current status of Mutual Recognition Agreements GMP sector |
| 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) |
| 2166 | Q 8 Pharmaceutical Development |
| 2176 | Q9 Quality Risk Management |
| 2199 | Providing Regulatory Submissions in Electronic Format - Content of Labelling |
| 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 |
| 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 |
