[医药卫生]FDA官员原料药检查指南中.docVIP

EDIT: Made available by ORA/OE/DCIQA 01/29/03 - undated MS Word file received from CDER table format revised Food and Drug Administration Compliance Program Guidance Manual PROGRAM 7356.002F CHAPTER 56 - DRUG QUALITY ASSURANCE 第56章—药物质量保证 SUBJECT: 主题 IMPLEMENTATION DATE *ACTIVE PHARMACEUTICAL INGREDIENTS (APIs)* 活性药物成分 Upon Receipt COMPLETION DATE Continuing DATA REPORTING PRODUCT CODES PRODUCT/ASSIGNMENT CODES Industry Codes: 54 and 56 See Below 56002F- Active Pharmaceutical Ingredient Process Inspections (Drug Quality Assurance) 56008A- Drug Product Surveillance, CDER Initiated 56008H- Drug Product Surveillance, Imported Drugs, CDER and District Initiated surveys 56R806- Foreign Routine Drug Surveillance Inspections* FIELD REPORTING REQUIREMENTS OAI ALERTS When the district becomes aware of any significant adverse inspectional, analytical, or other information that could or should affect the agencys new product approval decisions with respect to an *active pharmaceutical ingredient manufacturer referenced in an application, *the district should immediately notify HFC-240, Medical Products Quality Assurance Staff, via EMS or FAX. HFC-240 will then convey the information by FAX or equivalent expeditious means to the *Division of Manufacturing and Product Quality (HFD-320) in CDERs Office of Compliance.* When the district becomes aware of any significant adverse inspectional, analytical, or other information that could or should affect the agencys new product approval decisions with respect to an *active pharmaceutical ingredient manufacturer referenced in an application, *the district should immediately notify HFC-240, Medical Products Quality Assurance Staff, via EMS or FAX. HFC-240 will then convey the information by FAX or equivalent expeditious means to the *Division of Manufacturing and Product Quality (HFD-320) in CDERs Office of Compliance.*  PROCESS PROFILE REPORTING *In December 1995, at the request of CDER, the Medical Products Qualit