PRACTICAL STANDARDIZATION OF ORGANIC DRUGS
1 STATUS AND APPLICABILITY OF U S REGULATIONS: CURRENT GOOD MANUFACTURING PRACTICES IN MANUFACTURING, PROCESSING, PACKAGING, AND HOLDINGS OF DRUGS 3 ORGANIZATION AND PERSONNEL (SUBPART B) 4 BUILDINGS AND FACILITIES (SUBPART C) 5 EQUIPMENT (SUBPART D) 6 CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES (SUBPART E) 7 PRODUCTION AND PROCESS CONTROLS (SUBPART F) 8 PACKAGING AND LABELING CONTROLS (SUBPART G) 9 HOLDING AND DISTRIBUTION (SUBPART H) 10 LABORATORY CONTROLS (SUBPART I) 11 RECORDS AND REPORTS (SUBPART J) CONTENTS 12 RETURNED AND SALVAGED DRUG PRODUCTS (SUBPART K) 13 REPACKING AND RELABELING 14 BULK PHARMACEUTICAL CHEMICALS 15 THE PHARMACIST AND TOTAL QUALITY CONTROL 16 RECALLS AND CGMPS: ENFORCEMENT ALTERNATIVES IN THE UNITED STATES 17 CONTROLLED SUBSTANCES SAFEGUARDS (21 CFR 1300, ET SEQ ) 18 THE INSPECTION PROCEDURE FOR COMPLIANCE IN THE UNITED STATES: THE REGULATEE IS INSPECTED; THE RATIONALE FOR INSPECTION (21 USC 373, 374) 19 FDA PRE-APPROVAL INSPECTIONS/INVESTIGATIONS; THE ROAD FROM SUPAC TO THE FOOD AND DRUG MODERNIZATION ACT 20 WHO IS THE MANUFACTURER? SOME ADDITIONAL CONSIDERATIONS FOR THE MULTINATIONAL 21 OTHER GMPS 22 OTHER APPROACHES TO QUALITY 23 IMPORT AND EXPORT OF PHARMACEUTICALS AND OTHER PRODUCTS SUBJECT TO CGMPS 24 ENHANCEMENT OF GLOBAL PRODUCT DISTRIBUTION