106TPDA04014

衛 生 福 利 部 食 品 藥 物 管 理 署 委 辦 計 畫
「 推 動 新 興 生 醫 產 品 G M P 評 鑑 符 合 性 計 畫 」

新興生醫產品 GMP 訓練活動(3)、(4)

日 期 ：民 國 1 0 6 年 6 月 1 3 日

主辦單位：衛生福利部食品藥物管理署
承辦單位： 社團法人中華無菌製劑協會
 106TPDA04014

講 師 資 料
張華盛 GMP 專家/社團法人中華無菌製劑協會

時 間 表
時 間 內 容 講 師

8:30-9:00 報 到

TFDA
9:00-9:10 長 官 致 詞 風管組代表

TPDA
 ICH Q8：Pharmaceutical Development 說明
9:10-10:30 張華盛
 ICH Q9：Quality Risk Management 說明 GMP 專家

10:30-10:50 休 息

TPDA
 ICH Q9：Quality Risk Management 說明(續)
10:50-12:10 張華盛
 ICH Q10：Pharmaceutical Quality Systems 說明 GMP 專家

12:10-13:10 午 餐

TPDA
13:10-14:30  電腦化系統確效 張華盛
GMP 專家

14:30-14:50 休 息

TPDA
14:50-15:50  數據完整性 張華盛
GMP 專家

15:50-16:10 交 流 討 論 TFDA
風管組代表
16:10-16:30 課 後 測 驗 及講師
 106TPDA04014

目 錄
頁次

 ICH Q8/Q9/Q10, CSV & Data Integrity

- ICH Q8:Pharmaceutical Development

藥品開發………………………………………………………….. 5

- ICH Q9:Quality Risk Management

品質風險管理…………………………………………………….. 15

- ICH Q10:Pharmaceutical Quality Systems

製藥品質系統…………………………………………………….. 28

- Computerized System Validation

電腦化系統確效………………………………………………….. 36

- QRM Application for CSV

品質風險管理應用……………………………………………….. 50

- Data Integrity
數據完整性……………………………………………….………. 56

- Annex
參考資料………………………………………………….............. 71
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Chapter 4 (Part I): Documentation
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Chapter 6 (Part I): Quality Control

2

Chapter 5 (Part II): Process equipment (Computerized system)

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‡ ਧ‫ױ‬ङ‫ކ‬ў孙嬴ͫҿ௴⦙ਧ‫ױ‬ङ੧䔜嫅䷤͹‫ކ‬ў㚙实惨䠞孙嬴չ ‡ ३‫پ‬չ侳岡柾ऩ䬢ґ㩌族‫ߊޙ‬㶩孄厠-^6‫ݱ‬ҁգ࠵ͺ
ŽŶƚĞŵƉŽƌĂŶĞŽƵƐ
㚙实䬢ґ੽孄捦ङࡴ⥺֨ॱग੮ࠀ‫ކ‬ў߄ૡ‫ל‬ङॱ族孄捦 ‡ Ҫ孝▲✫ࡴ⥺बㆎՐ▲ࡴ⥺ङؔ㩌岃⣫ङ঒‫ײͧݏ‬㩌⧘঒
‡ ‫ߊޙ‬孄捦չࡴ⥺ङ㩌族҅ऀգ࠵ङ㩌族⚵࢛ͧ㐈۰չ朅匊ԗ঩佷 ‫ͨݏ‬
ङ㩌摺ͨҿЉਈੴߌ侙݉㺖ङы⬔ғ‫֨ݷ‬Օਈङ֪‫ͫސ‬۴ٗࡴ⥺ ‡ ঩佷֨ࡴ⥺ङգ㩌ㆎ㧠ऀ㛼ङՕऀ‫ۅ‬
ङ孄捦ङ‫ߊޙ‬չ㩌族㚙实ਘ⥺悹੧

‡ 㫮வङ३‫پ‬չ嬿俺չㅴ߾չ䲅߾չ㸮߲঒‫ݏ‬䬢ґ⬔ٗㆎԽ
‡ 㫮வङ३‫پ‬չ嬿俺չㅴ߾չչ䲅߾չਘ߲঒‫ݏ‬䬢ґы⬔ㅲ‫ޑ‬ㆎԽ ‫׷‬朅‫׿‬孄捦ⷫ੧ҭӣङㅴ߾չ‫܅‬䆯ͫԕ‫ܬ‬朅‫׿‬㦧㤜ङыٗ
‫׷‬㦧㤜ҭӣङㅴ߾չ‫܅‬䆯ͫԕ‫⚵ऀܬ‬孄捦գ࠵䙃Ոङ嶾嬶ङ伤㑋ͺ Օ岪Խ‫׷‬孄捦
‡ 㦧㤜ㅴ߾३‫پ‬㚙实‫ݔ‬ଚब昘ҫ㦧㤜ङㅴ߾҆‫ऀײ‬㧠ㅴ߾ङ㫮வ३ ‡ 㦧㤜ㅴ߾३‫پ‬㚙实‫ݔ‬ଚԽ‫׷‬朅‫׿‬㦧㤜չब昘ҫ㦧㤜ङㅴ߾
‫پ‬㚙੽ࡌ⬔ٗ宁ѳㆎ֨伤ߎ孄捦ЇङԽ‫׷‬嶾嬶ҟӟङғ‫ײ҆ͧݷ‬ ҆‫ऀײ‬㧠ㅴ߾ङ㫮வ३‫پ‬㚙实੽ࡌ⬔ٗ宁ѳ֨朅‫׿‬孄捦И
ऀ⤶۪݊㦧㤜伉࠳孄捦ङғ‫ͨݷ‬љ䬢ґ悤пғ‫ݷ‬ੴ惨䠞孄捦㎴߄ ㆎԽ‫׷‬嶾嬶ҟӟङғ‫֨ײ҆ͧݷ‬ଝ૭䲅߾۪㻴՗‫࠼؁‬И孄
屴㤜屴‫ͫޢ‬஬੽㩌寪߲ 捦ङ۪֨ҿѕ߄۞兴ङҫ㦧㤜И䤚䛂ङғ‫ͨݷ‬љ䬢ґ悤п
K ‡ 㦧㤜ㅴ߾ङ‫ކ‬ўㆎ㧠伤ߎ孄捦悤✫ପ‫ٯ‬ପ惐֨伤ߎ孄捦Ї乗դङ ғ‫ݷ‬ٝ侙ੴ惨䠞孄捦㎴߄屴㤜屴‫ͫޢ‬஬੽㩌寪߲
‫ڔސ‬੮‫ޢ‬ٝ侙ㅴ߾惐д֨孄捦‫܅‬䆯ީ䘹ॹ惐३ङ֪‫ސ‬悤✫Э㚙实 ‡ 㦧㤜ㅴ߾ङ‫ކ‬ўㆎ㧠朅‫׿‬孄捦ͫ悤✫ପ‫ٯ‬ପ惐朅‫׿‬乗০朅
ZĞǀŝĞǁŽĨŽƌŝŐŝŶĂů գ㶲֪乗դ㦧㤜ㅴ߾ङ㫮வ३‫پ‬㚙实昝‫ޢ‬ㅴ߾չ‫܅‬䆯乗դङ۞兴 ‫׿‬㦧㤜த⚵੮வٝ侙ㅴ߾չ‫܅‬䆯д㦧㤜ㅴ߾ङ㫮வ३‫پ‬㚙
ƌĞĐŽƌĚƐ ީ䔜д䬢ґब昘ы⬔ࣲઆѕ✰ҁ䔜ㅴ߾ৱչ‫܅‬䆯ৱङ刮嶣ީ䔜д 实昝‫ޢ‬ㅴ߾չ‫܅‬䆯乗դङ۞兴ީ䔜д䬢ґब昘ы⬔ࣲઆѕ
ґ屴‫ݕ‬сㅴ߾չ‫܅‬䆯ङ伤ߎ孄捦ङ؏‫ۅޅ‬澝䆯䬢‫ۅ‬澝▲ਚ‫ۅ‬չঅ ✰ҁ䔜ㅴ߾ৱչ‫܅‬䆯ৱङ嶣Ѡީ䔜дґ屴‫ݕ‬сㅴ߾չ‫܅‬䆯
ՠٝ‫ॹڏ‬ङ㶩䆯 ङ朅‫׿‬㦧㤜չҫ㦧㤜ङ؏‫ۅޅ‬澝䆯䬢‫ۅ‬澝▲ਚ‫ۅ‬չঅՠٝ
‡ ३‫پ‬㚙实‫ݔ‬ଚ‫ߧײ‬㦧㤜ㅴ߾䤚䛂掑寏۪惶ࢥ஬੽㠉Ոङ੧⥺३‫پ‬ ‫ॹڏ‬ङ㶩䆯
㚙实㎬ԉऀঅՠ-^6ङ‫ڔސ‬ㆎ㦧㤜ҟӟ‫۪࠳ݷ‬寕‫ͫޢ‬ӹ‫ީݕ‬Խ‫׷‬ ‡ ३‫پ‬㚙实‫ݔ‬ଚ‫ߧײ‬㦧㤜ㅴ߾䤚䛂掑寏۪惶ࢥ㚙实㠉Ոङ੧
孄捦ङՕ嫁‫ۅ‬չ‫࠳ݷ‬Օљऀଝ૭䲅߾ଝ૭ӱͫգ㩌҅ऀ'2)5' ⥺३‫پ‬㚙实㎬ԉऀঅՠ-^6ङ‫⚵ڔސ‬ㆎ㦧㤜悹੧‫۪࠳ݷ‬寕
Խ⤄ ‫ͫޢ‬ӹ‫ީݕ‬Խ‫׷‬孄捦ङՕ嫁‫ۅ‬չ‫࠳ݷ‬Օљऀଝ૭䲅߾ଝ૭
ӱͫգ㩌҅ऀ'2)5'Խ⤄
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WĂƉĞƌƌĞĐŽƌĚ ĞůĞĐƚƌŽŶŝĐƉĂƉĞƌ
‡ ⠾‫֨؂‬ҿѕ֪‫ސ‬ҁ䔜䤚ࣿ‫ږ‬૜Խ‫׷‬朅‫׿‬㦧㤜◁‫ע‬ङ䍿曱அ岡ङԽ‫׷‬朅
‫׿‬㦧㤜ङ‫➩ٯޙ‬ѡԀߎͺ
‡ 朅‫׿‬孄捦ङ঒‫ݏ‬ङ‫؍‬Ҷङ⠾‫ֿͫ⧘؂‬ԕ‫ܬ‬㸠ࠄ‫؜‬ͺ
‡ 伤ߎ孄捦঒‫ݏ‬չ‫؍‬Ҷङ‫ֿͫ⧘ݹ؂‬ԕ‫ܬ‬㸠ࠄ‫؜‬ͺ ‡ ܶؔङ朅‫׿‬㸠ࠄ঒ࣲ⬔ͫ҆‫ײ‬քп֨-26ܶԧИ੽ࡌङͫ㸠ࠄ঒ࣲ⬔
‡ ܶؔङ䘹ॹ㧠-^6‫ݱ‬ҁङ伤ߎ㸠ࠄ঒ࣲ⬔ީ-26ܶԧङ੽ࡌͺ 㚙䘹ॹ㧠-^6‫ݱ‬ҁͧܶؔы⬔㚙实侙惐ⷫ੧ѕ✰刮嶣ङ惨䠞ङ䬢宸㎴
֨ҿѕ->6И㻵㸠->6孄捦ङઅ਩չ刮嶣㚙实嫅ؔչ䥯‫▲ͧݏ‬ ߄ब昘侙樱չ惨䠞嬿俺ͨͺ
ਢ㚙实ީս巡ґ屴刮ਈୂ於ङ刮嶣۪▲✫䘹ॹङ‫ކ‬ў঒‫ୂݏ‬於ͨ‡ Ҫ孝ଊବ㸮ফङফ‫ږ‬ͺ
‡ Ҫ孝ଊବ㸮ফङ孄捦ङফ‫ږ‬ͺ ‡ ؔߊ䅍宒љ䬢宸㒡⠾‫؂‬ѹ৥㸮ফӱ㻵㸠朅‫׿‬㦧㤜ङਈԃ㒡⠾‫؂‬ѹ৥
‡ ׂ㧠梏暿宁ѳ惨䠞族ஜ㩌族ङؔߊ䅍宒⚵䬢宸㸮ফ㻵㸠ङ伤ߎ 㸮ফӱ㻵㸠㦧㤜ङਈԃ㚙֨朅‫׿‬㸠ࠄ‫؜‬䬢‫ߊݼ‬族䅍宒䬢‫ݼ‬д㒡⠾‫؂‬ѹ
۪杞㘟ࠀ‫ڔ‬孄捦ङਈԃͺ ৥㸮ফ㻵㸠㦧㤜ङਈԃ㒑㚙实ؔߊӇ䬢宸ͫԕ‫ܬ‬㒡আІ‫؂ސ‬⠾ङ㸮ফ
‡ ‫ߧײ‬Խ‫׷‬伤ߎ孄捦ٝ侙ҁ䔜ऱㅲԀߎ婂娸ۨд倴‫۪࣌ٵڳ‬倴‫҈ݕ ‡ ڳ‬ՠ惨ङ岪Ո孙➩҆‫ײ‬徣ў澝‫ݱ‬ҁ঩佷չ垵㤭ԗ䝬‫׋‬ঈљҎ֨஬੽
K 匿࣌⚵㻵㸠ͫ䠞஬੽㩌㚙‫҈ݕ‬ՠ惨ङ岪Ո孙➩ͫ҆‫ײ‬倴‫࣌ٵڳ‬ 㩌߲र㻵㸠ङ朅‫׿‬㦧㤜ͺ
۪倴‫ڳ‬匿࣌岪Ո֘ ‡ ‫੽ڷ‬㩌嫅ؔԕ‫ܬ‬љЈ࠵樹ङԽ‫׷‬朅‫׿‬孄捦怍㠹ۨऱㅲԀߎङ惐३ङ㫮
ZĞƚĞŶƚŝŽŶŽĨŽƌŝŐŝŶĂů
ƌĞĐŽƌĚƐŽƌƚƌƵĞ ‡ ‫੽ڷ‬㩌嫅ؔԕ‫ܬ‬љЈ࠵樹ङԽ‫׷‬伤ߎ孄捦怍㠹ۨऱㅲԀߎङ惐 வ३‫پ‬澝嬿俺澝ㅴ߾澝䲅߾չਘ߲͹
३ङ㫮வ३‫پ‬澝嬿俺澝ㅴ߾澝䲅߾չਘ߲͹ G 娸ҁԽ‫׷‬朅‫׿‬㦧㤜தङԀߎͫ߿㤜஬੽ґ‫؂‬Խ‫׷‬孄捦ࠀ‫⥺ͫڔ‬㘟
ĐŽƉŝĞƐ
G 娸ҁԽ‫׷‬伤ߎ孄捦ङԀߎͫ߿㤜஬੽ґ‫؂‬Խ‫׷‬孄捦ࠀ‫ͫڔ‬杞 ࠀ‫ऀ҅ײͧڔ‬ٝ䬢‫ݼ‬ङ➩ѡ惐३ㆎ朅‫׿‬㦧㤜չҫ㦧㤜ङҶୂ㦧㤜
㘟ࠀ‫࣌ࣁײͧڔ‬Ԁߎ澝6*,ͨͺ தङ㻵㸠Ԁߎͨͺ
H Ԁߎ஬੽厠Խ‫׷‬孄捦ࡁ忇⚵䬢ؔԀߎީիґऊдԽ‫׷‬孄捦ङ H আиы䬢宸ৱ۪‫܉‬妟䬢宸惐३ͧ҆‫܉ײ‬妟‫ށ‬ӧͨ⚵䬢宸➩ѡۨԅͫ
Ҷୂ⡦‫ؠ‬չ۞‫ͫۃ‬ԕ‫ܬ‬дҫ㦧㤜ͫ֨ԀߎИ㿮߄㦧㤜◁‫ײע‬ 㙢圧ҟӟङ朅‫➩׿‬ѡԀߎㆎԽ‫׷‬朅‫׿‬㦧㤜தङࡁ忇⚵䬢宸Ԁߎґ
ߧԀߎ੽অՠԽ‫׷‬伤ߎ孄捦ङऱㅲԀߎङ੽ࡌͫ孄捦ࠀ‫ڔ‬ґ ऊдԽ‫׷‬孄捦ङҶୂ⡦‫ؠ‬չ۞‫ײ҆ͧۃ‬ԕ‫ܬ‬д۱߄㦧㤜չҫ㦧㤜ͫ
ऊङ‫ڔސ‬厠孄捦ङ۞‫▲ۃ‬㶲୍੽ ֨ԀߎИ㿮߄㦧㤜◁‫ͫע‬ѠѾ⥺㘟孄捦ࠀ‫ڔ‬厠孄捦ङ۞‫▲ۃ‬㶲୍
I 䬢宸ৱऀ‫؍‬Ҷ搪‫ݎ‬ਙԀߎङ‫ڔސ‬䬢宸ͫ桨ॐ悤ީ▲✫ऱㅲԀ ੽ͫ岙䬤ੴґ‫ކͫ؂‬ў֨ٝ䬢‫ݼ‬ङ➩ѡ惐३ङㅲ‫ޑ‬惐३И㿮߄ੴ
ߎ۪‫҈ݕ‬बঈգङ屴㫮 㡦⻂ͨͺ
I ‫ߧײ‬Ԁߎঅՠҁ䔜Խ‫׷‬孄捦ङऱㅲԀߎङ੽ࡌͫ䬢宸ৱ۪‫܉‬妟䬢
宸惐३㚙实ㆊ䬢宸љ‫؍‬Ҷ搪‫ݎ‬ӱԀߎЇङ‫ڔސ‬孄捦ͫ屴‫ޢ‬悤ީ▲
✫ऱㅲԀߎ ϭϰϲ

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WĂƉĞƌƌĞĐŽƌĚ ĞůĞĐƚƌŽŶŝĐƉĂƉĞƌ
‡ Օ䟘ࣿӧԭ㱃ङ孙➩ङ䬢宸澝߻樱չ侳岡ͫ҆‫ٵמײ‬չV.⠌֘ͺ
‡ 䟘ࣿ澝垰ࣲ澝侳岡澝ӣ䤚۪㻵㸠朅‫׿‬孄捦ङ朅匊ԗ঩佷ङ䬢‫ݼ‬ͺ
‡ 䠞֨朅匊ԗ঩佷И族⡦ୂ怍१㦧㤜㩌‫ڷ‬栁䬢‫ݼ‬঩佷⚵䬢ґҿ؏‫ۅޅ‬ͺ
‡ ӣߤ‫ࡣސ‬ङ䬢‫ݼ‬ͺ
‡ ࣿ䟘娸३ङ䬢‫ݼ‬ͺ
‡ -^6孄捦ङㅴ߾ͺ
‡ 䠙‫ٯ‬澝Օए佖ߧչ559佖ߧङ寪߲ͺ
‡ չս巡঒ࣲ檥঩И孝‫ך‬ҿѕ梏暿঒ࣲ঒‫ݏ‬
㚙ऀ㧠㦧㤜ࣿոյߊङ悤п঒‫ݏ‬ङ҆‫׿‬㧠Јӧ
ґ屴䆯䬢ङ-^6孄捦ङ実伶梏暿঒ࣲৰ୏

 ‡ 侙惐݉㺖ङы⬔忼ҵ昘揗㦧㤜悹朅匊ͧ҆‫ײ‬П੽惐३Ҹ‫ڔ‬ङ忼ҵͨ੽ࡌㆎ۴⥺忼ҵङ㦧㤜ङ䆯䬢‫ۅ‬悹੧框‫י‬㸮߲悤✫㸮߲Օљं
আи✫侙惐݉㺖ङы۪ପ惐侙惐䬢‫ݼ‬ङ朅‫ࡣސ׿‬ପ惐䘹ॹङ䬢宸չ‫ݹ‬੧҅ऀ⚵悹੧҆‫ͫײ‬䔜д㸮䅍չ঒ࣲ厠昘揗㦧㤜ब昘ङ梏暿
ĐĐƵƌĂƚĞ ஬੽ंআи✫ы҆‫ײ‬ս巡ୂ於ы⬔⚵䬢宸३‫پ‬͹֨朅‫׿‬੮ࠀИ忼ҵ嬴঑Ҹ‫ڔ‬ͺ֨2/39И忼ҵП㦧㤜҆‫ऀײ‬㧠֨ӣߤ⸟ճ⯎И㶩
孄559қङս巡㶩䆯䷤ⴜङ‫࠼؁‬ͺ‫ߧײ‬஬੽ͫҿѕ昘揗П㦧㤜ͺՐ‫ޚ▲ͫי‬侙惐䬢宸ͫ䠞Օ੧չ惨ऀ㩌悤п昘揗㦧㤜‫࠼؁‬ㆊੴ
揸ؔљହҲ悹▲࠵ङғ‫⟔⟔ͫݷ‬ପ惐࠳‫ڔ‬ङ岴޾঒‫ࡶݏ‬३۵ਈғ‫ݷ‬
‡ 㦧㤜䙃Ո惐३ङ߄‫ީۅݼ‬䬢ґ䟘ࣿ௤ս巡㦧㤜ङׂ䭳
‡ ऀӱ㶩䆯宊Ӂ澝恜ࢁչ੮ࠀͧ‫⯎ײ‬ѹչӶ‫ͨچ‬ङ֪‫ސ‬㚙实Չ‫ݏ‬
‡ ֨঩佷Ф族怍१㦧㤜ङ惐३㚙实䬢‫ݼ‬
‡ 㦧㤜㒡঩佷१悹չ१ӟ஬੽‫ޢ‬䬢ङ嬴⤶ङ䅍宒չ঒‫ݏ‬
‡ 㩌族ՕਈЉީㆎ۱߄ࡴ⥺ୃ昘揗䠞ࡴ⥺ީㆎ㩌族昘揗㩌ͫӧԭङ孄捦㚙实桨ॐ㩌族‫ߊޙ‬㶩孄
‡ ҆‫ ײ‬䔜д䬢ґ֨‫ٵמ‬ӧԭӟङ伤㱃И孄捦ङ䱺୏㶲սङ䆯䬢‫ऀ҅֨ٵמͫۅ‬ӹ㚙实惨䠞֪߻䆯չ侳岡Ր‫ٵמ֨י‬Їգ࠵չ揸ؔ
ҫ㦧㤜孙ؔㆊ䬢ґ֨‫ٵמ‬ӧԭ伤㱃Ї䆯䬢孄捦㩌族‫ߊޙ‬

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ICH Q8(R2) – Pharmaceutical ICH Q9 – QRM ICH Q10 – PQS

Development Related Related Integrated
Related Activities Activities Activities
Quality Target ‡ Clinical and non-clinical studies on drug ‡ Informal and/or formal risk ‡ Knowledge Management /
Product Profile substance: bioavailability, PK/PD, and assessment to evaluate patient Prior Knowledge (relevant
(QTPP) safety needs and potential medication information to support the
risks understanding, risk
assessment and scope of
Pre-Formulation ‡ Characterization of drug substance ‡ Determine failure modes and risk
DOE)
Studies (physical properties) factors for drug substance
- Laboratory note book
‡ Chemical stability of drug substance, physical and chemical stability
documentation
degradation and potential formulation
- Development report
interactions
- Etc…
‡ Development of analytical tests
Formulation ‡ Excipient compatibility ‡ Determine failure modes and risk
Screening ‡ Dissolution method development factors for excipient interactions
‡ Screening DOEs
Formulation ‡ Excipient and drug substance material ‡ Opportunities for formal risk
Optimization and property & characterization assessment
Selection ‡ DOEs for excipient amounts
‡ Stability of drug product and storage
conditions
‡ Develop IVIVC relationships
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ICH Q8(R2) – Pharmaceutical ICH Q9 – QRM ICH Q10 – PQS

Development Related Related Integrated
Related Activities Activities Activities
Process ‡ Exploration of unit operations ‡ Determine failure modes, risk factors ‡ Batch records and
Screening ‡ Characterization of process for unit operations and rank risk operational guidelines
intermediates for manufacturing
‡ Tech Transfer report
Process ‡ DOEs for process parameters and ‡ Screening risk assessment to ‡ Identification and
Development interactions with material attributes determine potential parameters selection of suppliers
and ‡ Development of Design Space impacting product quality (e.g., that meet raw material
Optimization ‡ Operational ranges for scale- Ishikawa) needs
(Lab Scale) independent parameters ‡ Determine critical process steps,
‡ understanding of critical process process parameters and material
operations attributes (e.g., FMEA)
‡ Potential issues of scale
Process ‡ Pilot to verify lab scale knowledge ‡ Development of control strategy to
Development ‡ DOE and modeling effects of scale control risks incl. for scale up
and ‡ Development of design space
Optimization ‡ Development of on-line
(Pilot Scale) measurement technologies

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ICH Q8(R2) – Pharmaceutical ICH Q9 – QRM ICH Q10 – PQS

Development Related Related Integrated
Related Activities Activities Activities

‡ Gain product and process knowledge
‡ Knowledge supports transfer between
development and manufacturing to
achieve product realization
‡ Forms the basis for the manufacturing
process
‡ Improves effectiveness of control
strategy
‡ Contributes to processes validation and
ongoing continual improvement
‡ Advance understanding through scale-
up activities
‡ Provide preliminary indication of
process performance and successful
integration into manufacturing
‡ Gain knowledge from transfer and
scale up activities to enhance the
basis for the control strategy

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ICH Q8(R2) – Pharmaceutical ICH Q9 – QRM ICH Q10 – PQS

Development Related Related Integrated
Related Activities Activities Activities
Commercial Scale ‡ Definition of commercial ‡ Development of a control ‡ Process-specific operating
Manufacturing for process design strategy for commercial procedures (e.g. sampling plans,
Drug Product ‡ Commercial scale runs to verify manufacturing, including in- design space etc.)
process design, with additional process controls, end-product ‡ Documentation to support on-line
sampling to verify testing, raw material controls testing methods
understanding and change control ‡ Validation to demonstrate process
‡ Implementation of on-line ‡ Check procedures in the PQS and analytical method
measurement technologies regarding risk from Process reproducibility
specific procedure (e.g., ‡ Storage of development reports,
sampling plans, design space risk assessments
and model verification, change
control for movement within
design space)
Continual Process ‡ On-going analysis and trending ‡ Manage risks of process or ‡ Procedures on process
Verification and of process data, (multivariate material attribute change monitoring and action limits
Continual SPC, etc.) (including changes within or ‡ Change control procedures
Improvement ‡ Evaluation of process changes outside of design space) including how and when to do risk
and associated effect on ‡ Review risks in assessment for process changes
intermediates and products audits/inspections and and evaluation of the change
implement risk-based CAPAs ‡ Maintenance and update of
knowledge management

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