DRUG MASTER FILES (DMFs) ---------------------------------------------------------------------------------------------------------------------------------------------- Binder Specifications Drug Master Files (DMFs) Guideline for Drug Master Files SEP89 Drug Master Files Guideline
STABILITY ---------------------------------------------------------------------------------------------------------------------------------------------- SAS Drug Formulation Stablity Program ICH Q1 Stability Testing of New Drug Substances and Products Q1A(R) Stability Testing of New Drugs & Products (Rev) Q1B Photostability Testing Q1C Stability Testing for New Dosage Forms Q1D Bracketing & Matrixing Designs for Stability Testing (Drug Substances/Products) Q5B Genetic Stability Q5C Stability of Biotech/Biological Products
COMPLIANCE ---------------------------------------------------------------------------------------------------------------------------------------------- FDA Enforcement Report Application Integrity Policy Information Inspector's Technical Guide Current Good Manufacturing Practices (cGMP) Notes Private Laboratory Grassroots Meetings Laboratory Procedure Manual FDA Inspection Guides FDA Compliance Policy Guides FDA Compliance Program Guidance
WARNING LETTERS ---------------------------------------------------------------------------------------------------------------------------------------------- Warning Letters and Notice of Violation Letters Warning Letters by Subject Most Recent Warning Letters Warning Letters by Issuing Office Warning Letters Indexed by Date Warning Letters by Company
GOOD MANUFACTURING PRACTICES (GMPs) ---------------------------------------------------------------------------------------------------------------------------------------------- DRUG MANUFACTURING INSPECTIONS (Pilot Program) (1/9/01) CPGM for FDA Staff, 7356-002 Active Pharmaceutical Ingredients cGMP Notes FDA Inspectional Methods Container Closure Systems for Packaging Human Drugs & Biologics Current Codified cGMP Regulations 21 CFR Parts 210-211 Division of Manufacturing and Product Quality - Subject Contacts GMP Requirements & Quality System (QS) Regulation Information (CDHR) GMP Trends Medical Devices CGMP Quality System Regulation Final Rule Medicinal Chemistry Links Partial Extension of Compliance Date Proposed Amendments to Certain Requirements for Finished Phamaceuticals Referencing Discontinued Labeling for Listed Drugs in ANDAs Revision of Certain Labeling Controls
USEFUL WEB SITES ---------------------------------------------------------------------------------------------------------------------------------------------- American Association of Pharmaceutical Scientists AOAC (Association of Official Analytical Chemists) International California Separation Science Society Canada Good Manufacturing Practice Contract GMP Drug Product Manufacturers Contract GMP Synthesis Bulk Active Manufacturers Contract GMP/GLP Analytical Service Providers Contract GMP/GLP Analytical Service Providers Drug Development Approval Process Drug Discovery and Development Message Board International Society for Pharmacetical Engineering New Medicines in Development Office of New Drug Chemistry Organization Parenteral Drug Association Pharmaceutical Online Pharmaceutical Quality Group United States Pharmacopeia (USP)
PHARMACY COMPOUNDING ---------------------------------------------------------------------------------------------------------------------------------------------- Pharmacy Compounding
NATIONAL DRUG CODE (NDC) DIRECTORY ---------------------------------------------------------------------------------------------------------------------------------------------- NDC Directory Drug Registration and Listing Instructions The Online Guide to HPLC:
GMP- EUROPEAN LINKS ---------------------------------------------------------------------------------------------------------------------------------------------- Pharmacy Compounding Good Manufacturing Practices: European Community UK GMP & GDP Medicines Inspectorate Site Master File Guidelines (PIC/S PH 4/93) Sterility testing (PIC/S PE 001-2) Validation - Master Plan, IQ, OQ, PQ, Cleaning (PIC/S PR 1/99-2) Validation of Aseptic Processing (PIC/S PE 002-2) Quality System Requirements for Pharmaceutical Inspectorates (PIC/S PI 002-1)
INTERNATIONAL CONFERENCE ON HARMONIZATION (ICH) ---------------------------------------------------------------------------------------------------------------------------------------------- ICH M4 Common Technical Document- Main Document ICH M4 Common Technical Document- Quality ICH Q1 Stability Testing of New Drug Substances and Products Q1A(R) Stability Testing of New Drugs & Products (Rev) Q1B Photostability Testing Q1C Stability Testing for New Dosage Forms Q1D Bracketing & Matrixing Designs for Stability Testing (Drug Substances/Products) Q2A Text on Validations of Analytical Procedures Q2B Methodology Q3A Impurities in New Drug Substances Q3A(R) Impurities in New Drug Substances (Re) Q3B Impurities in New Drug Products Q3C Impurities: Residual Solvents Q5A Viral Safety Evaluation Q5B Genetic Stability Q5C Stability of Products Q5D Cell Substrates Q6A Chemical Substances Q6B Biotechnological Substances Q7A GMPs for Active Pharmaceutical Ingredients