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PIC/S GMP ANNEX1 3.6.

#1
Vicky 發表於 2015 / 01 / 28
為使因交叉污染所引起之嚴重醫療傷害的風險降到最低,對於一些特殊藥品的生產,例如高致敏性物質(例如:青黴素類)或生物性製劑(例如:來自活的微生物),應有專用且自足圍堵的設施;尚有一些產品,例如某些抗生素、某些荷爾蒙、某些細胞毒類、某些高活性藥物及非藥品的生產不得在同一設施中為之。
Q: 想請教 某些荷爾蒙 有包含steroid類固醇藥物嗎?(如:Dexamethasone ;Prednisolone )
TPDA 發表於 2015 / 01 / 29
法規上並未指明是哪一種荷爾蒙,但通常不包括steroid類固醇藥物(如:Dexamethasone; Prednisolone ),過去曾被認定是性荷爾蒙,尤其是女性荷爾蒙(estrogen)。但此條文一直受到挑戰。所以EU於2014公告新版GMP Guide Part 1 的第三章已做了適當的修正,根據品質風險評估的結果,決定是否要使用專用設施。摘錄原文如下:
3.6 Cross-contamination should be prevented for all products by appropriate design and operation of manufacturing facilities. The measures to prevent cross-contamination should be commensurate with the risks. Quality Risk Management principles should be used to assess and control the risks.

Depending of the level of risk, it may be necessary to dedicate premises and equipment for manufacturing and/or packaging operations to control the risk presented by some medicinal products.

Dedicated facilities are required for manufacturing when a medicinal product presents a risk because:
i. the risk cannot be adequately controlled by operational and/ or technical measures,
ii. scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly sensitising materials such as beta lactams) or
iii. relevant residue limits, derived from the toxicological evaluation, cannot be satisfactorily determined by a validated analytical method.

Further guidance can be found in Chapter 5 and in Annexes 2, 3, 4, 5 & 6.
Vicky 發表於 2015 / 01 / 30
感謝賜教
Vicky 發表於 2015 / 01 / 30
感謝賜教
Tom 發表於 2015 / 04 / 22
不好意思,我的問題與此題目相似:想請教 某些荷爾蒙 有系統性荷爾蒙藥物嗎?(如FLUDROCORTISONE ACETATE) , Thanks
TPDA 發表於 2015 / 04 / 27
此問題可參考 交流園地相關問題
網址如下:http://www.pdatc.org.tw/qa_detail_874.htm

 

 

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