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Tel:153 2100 2012

Beijing Four Sentences of Heng Qu science and technology Co., Ltd.
北京橫渠四句科技有限公司
WHO發(fā)布《制藥生產(chǎn)技術(shù)轉(zhuǎn)移指南》!
來源: | 作者:4SHQ | 發(fā)布時間: 286天前 | 6255 次瀏覽 | 分享到:



7,、給出分析方法轉(zhuǎn)移過程中可能的實驗設(shè)計和接受標(biāo)準(zhǔn):


Test

測試

Considerations

for transfer

轉(zhuǎn)移的考量

Replication

of tests

測試重復(fù)次數(shù)

Set-up

設(shè)置

Acceptance criteria Direct

接受標(biāo)準(zhǔn)

Statistically derived

統(tǒng)計推導(dǎo)

Assay for potency

效價分析

Specific methods where possible should be used

如有可能應(yīng)使用專屬性方法

 

A bracketing approach may be used for multiple strengths

對于不同規(guī)格可使用括號法

At each site:

每個實驗室:

2 analysts × 3 lots, in triplicate (= 18 per site)

2分析師× 3批,重復(fù)三次(每個實驗室18次)

Different sets

of instruments and columns

不同的儀器和柱組合

 

Independent solution preparation

獨立的溶液配制

Comparison of mean and variability

比較平均值和偏差

Two one sided t-tests with inter-site differences ≤2% , 95% confidence

雙單側(cè)t檢驗,,實驗室間差異≤2% @95%置信度

Content

Uniformity

含量均勻性

If method is equivalent to assay method, separate transfer is not  usually required

如果該方法與含量測定方法等同,,則通常不需要分別

轉(zhuǎn)移

At each site:

每個實驗室:

2 analysts, × 1 lot (= 2 per site)

2分析師×1批(=每個實驗室2次)

Different sets of instruments and columns

不同的儀器和柱組合

 

Independent solution preparation

獨立的溶液配制

Mean at RU within ± 3% of mean at SU;

接收方的平均值在轉(zhuǎn)移方平均值的±3%以內(nèi)

 

comparison of relative standard deviation

比較相對標(biāo)準(zhǔn)偏差

Two one sided t-tests with inter-site differences ≤ 3% , 95% confidence

雙單側(cè)t檢驗,實驗室間差異≤3% @95%置信度

Dissolution

溶出度

Bracketing may

be appropriate for multiple strengths

對于不同規(guī)格可使用括號法

6 units (12, if not routine at RU, and for extended release products)

6個單位(12個,,如接收方不作為常規(guī)測試,,和延長放行產(chǎn)品)


Mean at RU within ± 5% of mean at SU

接收方的平均值在轉(zhuǎn)移方平均值的±5%

Compare profile (e.g. F2), or compare data at Q time points, as for  assay

比較資料(F2),或比較Q時間點的數(shù)據(jù)