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Page 1 of 38 FOO D AND DRUG ADMINISTRATION COMPLIANC E PROGRA M GUIDANC E MANUA L PROGRA M 7356.002A CHAPTER 56 ΠDRUG QUALITY ASSURANCE SUBJEC T: STERILE DRUG PROCESS INSPECTIONS Revision Note: Program revised 09/11/2015 to update implementation date, completion date, organizational/procedural changes and program contacts. IMPLEMEN TATION DATE September 11 , 2015 COMPLE TION DATE September 11, 2016 DATA REPOR TING PRODUC T CODES PRODUC T/ASSIGNMEN T CODES Industry codes 54, 56 and 60 -66 inclusive Domestic / Foreign Inspections: 56002A (Full Inspection) 56002I (Abbreviated Inspection) Related PACs 56002 56002C 56002M FIEL D REPORTIN G REQUIREMENTS: Establishment Inspection Reports (EIRs) are to be created and filed electronically using the specific module in TurboEIR or replacement system that is accessible to both ORA and CDER. For inspections of routine commercial manufacturing classified as Official Action Indicated (OAI) due to failure to comply with 21 CFR Part 210 and 211 Current Good Manufacturing Practice (CGMP) as they apply to sterile drug process inspections , submit adv isory, administrative, or judicial action recommendations via MARCS -CMS in accordance with the Regulatory Procedures Manual (RPM). Districts should immediately report significant issues according to current FACTS, Panorama and CMS procedures. This includes promptly filing and changing OAI notifications. During an inspection, if you obtain information pertaining to inadequate adverse drug experience (ADE) reporting, unapproved drug issues, or post -approval reporting violations (application supplements, Field Alert Reports (FARs), etc.), report in accordance with directions provided in the applicable compliance programs and under separate captions in the EIR. Data system information about these inspectional activities should be reported under separate Program Assignment Codes (PACs). Expansion of coverage under these programs into a CGMP inspection should be reported under this compliance program.
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