4.25 If the laboratory has more than one option specified for slide drying, are criteria included for when each - - 5.3.1 Recommendation option will be used? 4.26 That positive and negative staining controls are 14.1 14.1.3 - Requirement prepared at the same time the slides are prepared? 4.27 Acceptable sample purification and slide Critical preparation procedures, including issues not noted GLP in items 4.1 through 4.26? 5 Sample Staining 5.1 Which stain to use and to follow manufacturer’s 14.2 14.2 5.3.2 Method Procedure instructions for FITC stain application? 5.2 The slides are incubated in a humid chamber in the dark at room temperature for approximately 30 14.3 14.3 5.3.3 Method Procedure minutes or per manufacturer’s directions? 5.3 The working DAPI stain is prepared the day it is 7.7.2 7.9.2 3.19.2 Method Procedure used? 5.4 The stock DAPI is stored at 1 to 10oC in the dark? 7.7.1 7.9.1 3.19.1 Method Procedure 5.5 The volume of working DAPI applied and the 14.6 14.6 - Method Procedure incubation time? 5.6 The technique used to drain the excess stain from 14.5 14.5 - Method Procedure the well and to rinse the well? What type and amount of mounting used? 7.8 7.10 - Method Procedure 5.8 That all the edges of the cover slip are sealed well with clear fingernail polish, unless Elvanol® is 14.9 14.9 - Method Procedure used? 5.9 The finished slides or slides not read immediately are stored in a humid chamber in the dark at 1o to 14.10 14.10 5.3.6 Method Procedure 10oC (humid chamber not required for Elvanol®)? 5.10 Acceptable sample staining procedures, including Critical issues not in items 5.1 through 5.9? GLP
4.25 If the laboratory has more than one option specified for slide drying, are criteria included for when each option will be used? - - 5.3.1 Recommendation 4.26 That positive and negative staining controls are prepared at the same time the slides are prepared? 14.1 14.1.3 - Requirement 4.27 Acceptable sample purification and slide preparation procedures, including issues not noted in items 4.1 through 4.26? Critical GLP 5 Sample Staining 5.1 Which stain to use and to follow manufacturer’s instructions for FITC stain application? 14.2 14.2 5.3.2 Method Procedure 5.2 The slides are incubated in a humid chamber in the dark at room temperature for approximately 30 minutes or per manufacturer’s directions? 14.3 14.3 5.3.3 Method Procedure 5.3 The working DAPI stain is prepared the day it is used? 7.7.2 7.9.2 3.19.2 Method Procedure 5.4 The stock DAPI is stored at 1 to 10oC in the dark? 7.7.1 7.9.1 3.19.1 Method Procedure 5.5 The volume of working DAPI applied and the incubation time? 14.6 14.6 - Method Procedure 5.6 The technique used to drain the excess stain from the well and to rinse the well? 14.5 14.5 - Method Procedure What type and amount of mounting used? 7.8 7.10 - Method Procedure 5.8 That all the edges of the cover slip are sealed well with clear fingernail polish, unless Elvanol® is used? 14.9 14.9 - Method Procedure 5.9 The finished slides or slides not read immediately are stored in a humid chamber in the dark at 1o to 10oC (humid chamber not required for Elvanol®)? 14.10 14.10 5.3.6 Method Procedure 5.10 Acceptable sample staining procedures, including issues not in items 5.1 through 5.9? Critical GLP