Statements (52)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:appliesTo |
drug manufacturers
processing of drugs finished pharmaceuticals domestic drug manufacturers foreign drug manufacturers supplying to the U.S. holding of drugs packing of drugs |
| gptkbp:citation |
Current Good Manufacturing Practice for Finished Pharmaceuticals
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:establishes |
minimum requirements for drug manufacturing
|
| gptkbp:focusesOn |
Current Good Manufacturing Practice (CGMP)
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR Parts 210 and 211
|
| gptkbp:issuedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:partOf |
Code of Federal Regulations Title 21
|
| gptkbp:regulates |
manufacturing of pharmaceutical drugs
|
| gptkbp:requires |
record keeping
environmental monitoring quality control written procedures equipment maintenance personnel training sampling procedures complaint handling recall procedures distribution records sterility assurance stability testing proper documentation quarantine procedures batch production records control of closures control of components control of cross-contamination control of drug product containers control of microbiological contamination distribution controls investigation of discrepancies labeling controls packaging controls relabeling procedures reprocessing procedures returned drug product procedures sanitation and cleanliness testing of finished products testing of raw materials validation of processes |
| gptkbp:startDate |
1978
|
| gptkbp:bfsParent |
gptkb:current_Good_Manufacturing_Practice
gptkb:FDA_Current_Good_Manufacturing_Practice gptkb:Current_Good_Manufacturing_Practice_(cGMP) |
| gptkbp:bfsLayer |
8
|