Page 54 Appendix 1 ISPE Good Practice Guide:
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
Administration Identity
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 standard 95.0 – 105.0%
7HVW 1DPHAppearance (visual)
4XDOLW\ $WWULEXWHV
Acceptance Criteria PJ :KLWH URXQG ¿OP FRDWHG tablet debossed (Example 10) PJ
Ö
Ö
Strength Assay (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 USP 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 Ingredients Shelf Life
Packaging Materials
Meets pharmacopoeia requirements
0HDQ GLVVROXWLRQ dissolved in 30 minutesMeets pharmacopoeia requirements US, EU, Japan
Acceptable for intended markets36 months
PVC blister with aluminum foil backing, Induction sealed HDPE bottle
Blister and bottles
ÖÖÖÖÖÖÖ
Uniformity of Dosage Units Dissolution
Microbiological LimitsExcipient C of A/Compendial Testing
ICH Stability TestingC of A provided by Supplier Package Check
0HHWV VSHFL¿FDWLRQV DW HQG RI shelf lifeConforms
Primary PackagingConforms
For individual use only. Copyright ISPE 2014. All rights reserved.
Page 54 Appendix 1 ISPE Good Practice Guide:
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
Administration Identity
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 standard 95.0 – 105.0%
7HVW 1DPHAppearance (visual)
4XDOLW\ $WWULEXWHV
Acceptance Criteria PJ :KLWH URXQG ¿OP FRDWHG tablet debossed (Example 10) PJ
Ö
Ö
Strength Assay (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 USP 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 Ingredients Shelf Life
Packaging Materials
Meets pharmacopoeia requirements
0HDQ GLVVROXWLRQ dissolved in 30 minutesMeets pharmacopoeia requirements US, EU, Japan
Acceptable for intended markets36 months
PVC blister with aluminum foil backing, Induction sealed HDPE bottle
Blister and bottles
ÖÖÖÖÖÖÖ
Uniformity of Dosage Units Dissolution
Microbiological LimitsExcipient C of A/Compendial Testing
ICH Stability TestingC of A provided by Supplier Package Check
0HHWV VSHFL¿FDWLRQV DW HQG RI shelf lifeConforms
Primary PackagingConforms
For individual use only. Copyright ISPE 2014. All rights reserved.