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4FDA Submitting Samples and Analytical Data for Methods Validation
6FDA Format and Content for the CMC Section of an Annual Report, 1994
8FDA NDAs: Impurities in Drug Substances (Feb. 2000)
9FDA Investigating Out of Specification (OOS) results for Pharmaceutical Production
12FDA Changes to an Approved NDA or ANDA, Revision 1
15FDA PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites, April 1998
16FDA SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum
17ORA Inspectional References Guide to Inspectors of Quality Systems, August 1999
19Industry Survey on Current Sterile Filtration Practices
21The Application of the principles of Good Laboratory Practice and the verification of their Application for Tests on Chemical Substances
27Impurities in New Drug Substances
32ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
33ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
34Impurities: Residual Solvents (CPMP/ICH/283/95)
36ICH Q1A(R2) Stability Testing of new drugs and products (Revised guideline)
38ICH Q3B(R2) Impurities in New Drug Products
40Stability Testing of Drug Substances and Drug Products
42FDA 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
47Drug Master Files for Bulk Antibiotic Drug Substances
48FDA The Sourcing and Processing of Gelatin to reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy, December 2000
49FDA SUPAC-IR: Questions and Answers about SUPAC-IR Guidance
50FDA Reviewer Guidance: Validation of Chromatographic Methods, 1994
56BACPAC I: (withdrawn) Intermediates in Drug Substance Synthesis, Bulk Actives Post-approval Changes: Chemistry, Manufacturing and Controls Documentation
79FDA Computerized Systems used in clinical trials-Draft
80FDA Drug Master Files, September 1989
84ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
102PIC/S Explanatory Note for Industry on the Preparation of a Site Master File (PE 008-4) Jan 2011
108Aseptic processing of health care products- Part 1: General requirements
109PIC/S Validation of Aseptic Processing (PI 007-6) 2011
110Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations
111Validation of Computer-related Systems TR 18
113Validation and Qualification of Computerized Laboratory Data Acquisition Systems
114GAMP Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach
11521 CFR Part 211 Current Good Manufacturing Practice
116FDA Guide to Inspections of Computerised Systems in Drug Processing, February 1983
11721 CFR Part 11 Electronic Records, Electronic Signatures
119FDA Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice, September 2004
120EU GMP Annex 1: Manufacture of Sterile Medicinal Products - revision November 2008
121EU GMP Annex 2: Manufacture of Biological Medicinal Products for Human Use
122EU GMP Annex 3: Manufacture of Radiopharmaceuticals
124EU GMP Annex 5: Manufacture of Immunological Veterinary Medicinal Products
125EU GMP Annex 6: Manufacture of Medicinal Gases
127EU GMP Annex 8: Sampling of Starting and Packaging Materials
128EU GMP Annex 9: Manufacture of Liquids, Creams and Ointments
129EU GMP Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
131EU GMP Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products
138Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
140Sterile Pharmaceutical Packaging: Compatibility and Stability
142Review of Commercially Available Particulate Measurement Systems
143Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers
144Sterilization of Parenterals by Gamma Radiation
145Siliconization of Parenteral Drug Packaging Components
146Fundamentals of a Microbiological Environmental Monitoring Program
147Industry Perspective on the Validation of Column-Based Separation Processes for the Purification of Proteins
148Industrial Perspective on Validation of Tangential Flow Filtration in Bio-pharmaceutical Application
149Effect of Gamma Irradiation on Elastomeric Closures
150Current Practices in the Validation of Aseptic Processing
151Rapid/Automated ID Methods Survey
152Report on Survey of Current Industry Gowning Practices
153Bioburden Recovery Validation
154Design And Validation Of Isolator Systems For The Manufacturing And Testing Of Health Care Products
159PIC/S Recommendations on Sterility Testing (PI 0012-3) Sept 2007
160Process Simulation Testing for Aseptically filled Products
161Sterilizing Filtration of Liquids
162Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat
163ISPE Baseline Guide: Biotech
164ISPE Baseline Guide: Guide Water and Steam Systems
165ISPE Baseline Guide: Oral Solid Dosage Guide
166ISPE Baseline Guide: Sterile Manufacturing Facilities
167ISPE SUPAC Guide (Similar Equipment)
170Validation of Steam Sterilisation Cycles: Technical Monographs Nr. 1
171Current Practices in the Validation of Aseptic Processing
172Blend Uniformity Analysis: Validation and In-Process Testing
173Points to Consider for Cleaning Validation
174Pharmaceutical Package Integrity
176EU GMP Annex 15: Qualification and Validation
177EU GMP Annex 16: Certification by a Qualified Person and Batch release
178EU GMP Annex 17: Parametric Release
180ISPE Baseline Guide: Commissioning and Qualification
181ISPE Baseline Guide: Packaging, Labeling and Warehousing Facilities
207FDA Guide to Inspections of Cosmetic Product Manufacturers, February 1995
208FDA Guide to Inspections of Oral Solutions and Suspensions, August 1994
209FDA Guide to Inspections of Sterile Drug Substance Manufacturers, July 1994
210FDA Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation, January 1994
211FDA Guide to Inspections of Dosage Form Drug Manufacturers, October 1993
212FDA Guide to Inspections of Validation of Cleaning Processes, July 1993
213FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories, July 1993
214FDA Guide to Inspections of High Purity Water Systems, July 1993
215FDA Guide to Inspections of Lyophilisation of Parenterals, July 1993
216FDA Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, July 1993
217FDA Guide to Inspections of Topical Drug Products, July 1994
218Sterilization Process Validation, January 1993
220FDA Guide to Inspections of Foreign Pharmaceutical Manufacturers, (5/96)
221FDA Biotechnology Inspection Guide, November 1991
257Biological Testing of Medicinal and Dental Materials and Devices Part 1: Guidance on Selection Tests
259Validation for Medical Devices and Diagnostic Manufacturers
270ISO 13683 Sterilization of health care products
271Medical devices -- Application of risk management to medical devices - Medizinprodukte - Anwendung des Risikomanagements auf Medizinprodukte
273Quality systems Medical devices - Particular requirements for the application of ISO 9001
276FIP Guidelines for Dissolution Testing of Solid Oral Products
285Eudralex Volume 3 Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products
286Note for Guidance on Medicinal Gases: Pharmaceutical Documentation
288Note for Guidance on Quality of Water for Pharmaceutical Use (Rev.)
290Note 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
292Guideline on the Investigation of Bioequivalence
319Certificate of Pharmaceutical Product - Application Instructions -
322Standard Abbreviations (Acronyms)
32621 CFR Part 800 Medical Devices - General
32721 CFR Part 820 (Quality System Regulation)
32821 CFR Part 7 Enforcement Policy
32921 CFR Part 600 Biological Products: General
33021 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components
33121 CFR Part 610 General Biological Products Standards
33221 CFR Part 314 Applications for FDA approval to market a new drug
33421 CFR Part 312 Investigational New Drug Application
340FDA Glossary of Computerized System and Software Development Terminology
342FDA Bioresearch Monitoring Inspections of In Vitro Diagnostic Devices
344FDA Guide to Inspections of Medical Device Manufacturers (12/97)
358FDA Guide to Inspections of Foreign Medical Device Manufacturers (9/95)
378FDA Guide to International Inspections and Travel
379FDA Compliance Program Guidance Manual
380FDA Medical Device Reporting: An Overview
381FDA Compliance Program Guidance Manual 7348.808 Good Laboratory Practice (02/2001)
382Compliance Program Guidance Manual 7356.002 Drug Manufacturing Insections (02/2002)
383ISPE Good practice Guide Commissioning and Qualification of Pharmaceutical Water and Steam Systems
387FDA Guide to Inspections of Quality Systems (08/99)
388FDA Q 9: ICH Draft Consensus Guideline: Q9 Quality Risk Management
468FDA "Do It By Design: An Introduction to Human Factors in Medical Devices"
470FDA Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System Regulation
471FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff
4792001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Consolided version: 20/01/2011).
4822001/20/EC - Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use - English Version
485FDA Guide to Bioresearch Monitoring Inspections of in vitro Diagnostic Devices
490FDA Alternative to Certain Prescription Device Labeling Requirements
492FDA Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems
494Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Final Guidance for Industry and FDA
495FDA Inspections of Medical Device Manufacturers
496FDA Guide to Inspections of Infectious Disease Marker Testing Facilities
497Third Party Review; An Instruction Manual For Conducting Reviews of Premarket Notifications
501FDA Medical Device Reporting for Manufacturers
502In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
510FDA Environmental Assessment of Human Drug and Biologics Applications
511Format and Content of the Chemistry, Manufacturing and Controls Section of an Application
518FDA SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
519FDA SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In-Vitro Release Testing and In Vivo Bioequivalence Documentation
522Submission of Chemistry, Manufacturing and Controls Information for Synthetic Peptide Substances
523Submitting Documentation for the Manufacture of and Controls for Drug Products
526FDA Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
528FDA SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum
529FDA Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Issued 7/1997, Posted 7/28/1997)
530FDA Container Closure Systems for Packaging Human Drugs and Biologics
531Submitting Documentation for the Stability of Human Drugs and Biologics
538FDA Monoclonal Antibodies Used as Reagents in Drug Manufacturing (Issued 3/2001, Posted 3/28/2001)
545FDA Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products (Issued 5/1999, Posted 6/2/1999)
559ANDA's: Impurities in Drug Substances
564FDA ANDAs: Impurities in Drug Products
566FDA Q1A(R2)Stability Testing of New Drug Substances and Products
567FDA Q1B Photostability Testing of New Drug Substances and Products
569FDA Q2A Validation of Analytical Procedures
570FDA Q2B Validation of Analytical Procedures: Methodology
571FDA Q3A Impurities in New Drug Substances, Revision 2
572FDA Q3B(R) Impurities in New Drug Products
573FDA Q3C Impurities: Residual Solvents
574FDA Q3C Tables and List
575FDA Q3C Impurities: Residual Solvents Appendix 4
578Eudralex Volume 3 FDA Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
579FDA Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
581FDA Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability
582FDA Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
583FDA Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products
584FDA Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
649EC-USA MRA, Sectoral Annex on Good Manufacturing Practices (GMP)
650Japanese Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processong
652Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs
654Questions and Answers regarding "Guideline on Management of Computerized Systems for Marketing Authorisation Holders and Manufacturers of Drugs and Quasi-drugs
698The Barr Case
706Eudralex Volume 2B - Medicinal products for human use - Presentation and content of the dossier - Common Technical Document (CTD)
711EU Compilation of Community Procedures on Inspections and Exchange of Information
712Eudralex Volume 10 Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents
753Eudralex Volume 2A Chapter 1 - Marketing Authorisation (updated version - June 2013)
754Eudralex Volume 2A Chapter 2 - Mutual Recognition (updated version - February 2007)
755Eudralex Volume 2A Chapter 3 - Community Referral (updated version - September 2007)
756Eudralex Volume 2A Chapter 4 - Centralised Procedure (updated version - April 2006)
757Eudralex Volume 2A Chapter 5 - Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures
758Eudralex Volume 2A Chapter 6 - Community Marketing Authorisation (updated version - November 2005)
778Eudralex Volume 2C Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (October 2003)
779Eudralex Volume 2C Guideline on the processing of renewals in the centralised procedure
783Eudralex Volume 2C Guideline on Summary of Product Characteristics (September 2009)
787Eudralex Volume 2C Guideline on the packaging information of medicinal products for human use authorised by the Union
788Eudralex Volume 2C Guideline on changing the classification for the supply of a medicinal product for human use
789Eudralex Volume 2C Guideline on the readability of the label and package leaflet of medicinal product for human use, revision 1 (12 January 2009)
795ICH Q10 Pharmaceutical Quality System
835EU GMP Chapter 1: Pharmaceutical Quality System
836EU GMP Chapter 2: Personnel
837EU GMP Chapter 3: Premises and Equipment
839EU GMP Chapter 5: Production

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