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SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED …
83_____3AQ11a nSPECIFICATIONS AND CONTROL TESTS ON THEFINISHED PRODUCTG uideline TitleSpecifications and CONTROL TESTS on the FINISHED ProductLegislative basisDirective 75/318/EEC as amendedDate of first adoptionDecember 1991 Date of entry intoforceJune 1992 StatusLast revised 1991 Previous titles/otherreferencesControl of the FINISHED Product/ III/3324/89 Additional NotesThis note for guidance concerns the application of Part 2,section E of the Annex to Directive 75/318/EEC asamended, with a view to the granting of a marketingauthorisation for a new medicinal ANALYSISAPPENDIX85_____3AQ11a nSPECIFICATIONS AND CONTROL TESTS ON THEFINISHED PRODUCTNote for guidance concerning the application of Part 2, section E of the Annex to Directive75/318/EEC as amended, for the purposes of granting a marketing glossary of terms used is included in an appendix to this characteristics covered by the specificationsQuality characteristics cover the following area: general characteristics of the pharmaceutical form, particularly pharmacotechnical;that is to say those characteristics, determined in general by physical TESTS with limitsof acceptance, relating to the product performance or handling ( hardness, friabilityof a conventio)
85 _____ 3AQ11a SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Note for guidance concerning the application of Part 2, section E of the Annex to Directive
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