目标产品质量概况 20151005 tr

Technology Transfer

7 Appendix 1 – Quality Target Product Profile Example for a Film Coated Tablet

4XDOLW\\󰀃7DUJHW󰀃3URGXFW󰀃3UR¿OH󰀃IRU󰀃7DEOHWV󰀃;3URGXFW󰀃$WWULEXWHDosage FormTablet ColorTablet ShapeTablet DebossingTablet Weight(s)Mode of

AdministrationIdentity

Target

Immediate release tablets with ¿OP󰀃FRDWLQJ

White (10 mg), Yellow (20 mg)Round for 10 mg, Oval for 20 mgExample 10 for 10 mgExample 20 for 20 mg

󰀕󰀓󰀓󰀃PJ󰀃󰀋󰀔󰀓󰀃PJ󰀌󰀃ZLWK󰀃¿OP󰀃FRDWLQJ󰀗󰀓󰀓󰀃PJ󰀃󰀋󰀕󰀓󰀃PJ󰀌󰀃ZLWK󰀃¿OP󰀃FRDWLQJOral (once daily)

Positive for active ingredient

ID (HPLC)

Chromatogram matches reference standard

Spectrum matches reference standard95.0 – 105.0%

7HVW󰀃1DPHAppearance (visual)

4XDOLW\\󰀃$WWULEXWHV

Acceptance Criteria󰀔󰀓󰀃PJ󰀝󰀃:KLWH󰀃URXQG󰀃¿OP󰀃FRDWHG󰀃tablet debossed (Example 10)󰀕󰀓󰀃PJ󰀝󰀃Ö

Ö

StrengthAssay (HPLC)Degradants and Impurities

10 mg and 20 mg

95.0 – 105.0% of Label ClaimMeets criteria of ICH Q3B(R2)

ID (UV)Assay

Ö

Individual known

Degradation Products

Not more than 2.0%Not more than 0.5% eachNot more than 1.5%Conforms to USP <905>USP <711> Not less than 75% (Q) of LC dissolved in 30 minsMeets pharmacopoeia requirements

Conforms with USP/NF, EP, and JP

Ö

Individual unknown Degradation ProductsTotal Degradation

Uniformity of DoseIn vitro AvailabilityMicrobiological LimitsIntended MarketsFormulation IngredientsShelf Life

Packaging Materials

Meets pharmacopoeia requirements

0HDQ󰀃GLVVROXWLRQ󰀃󰂕󰀃󰀛󰀓󰀈󰀃dissolved in 30 minutesMeets pharmacopoeia requirementsUS, EU, Japan

Acceptable for intended markets36 months

PVC blister with aluminum foil backing, Induction sealed HDPE bottle

Blister and bottles

ÖÖÖÖÖÖÖ

Uniformity of Dosage UnitsDissolution

Microbiological LimitsExcipient C of A/Compendial Testing

ICH Stability TestingC of A provided by SupplierPackage Check

0HHWV󰀃VSHFL¿FDWLRQV󰀃DW󰀃HQG󰀃RI󰀃shelf lifeConforms

Primary PackagingConforms

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