问题 单项选择题

根据《药品生产质量管理规范》(2010年版),可由一定数量的产品经最后混合所得的在规定限度内的均质产品为一批的是()。

A.粉针剂

B.间歇生产的原料药

C.大(小)容量注射剂

D.连续生产的原料药

答案

参考答案:B

解析:

本组题考查要点是"药品批次划分原则"。

无菌药品和原料药品批次的划分依据不同的标准,具体情况如下:

①大(小)容量注射剂以同一配液罐最终一次配制的药液所生产的均质产品为一批;同一批产品如用不同的灭菌设备或同一灭菌设备分次灭菌的,应当可以追溯。

②粉针剂以一批无菌原料药在同一连续生产周期内生产的均质产品为一批。

③冻干产品以同一批配制的药液使用同一台冻干设备在同一生产周期内生产的均质产品为一批。

④眼用制剂、软膏剂、乳剂和混悬剂等以同一配制罐最终一次配制所生产的均质产品为一批。

⑤连续生产的原料药,在一定时间间隔内生产的在规定限度内的均质产品为一批。

⑥间歇生产的原料药,可由一定数量的产品经最后混合所得的在规定限度内的均质产品为一批。

单项选择题

German Chancellor Angela Merkel won over German voters in the Federal Election on Sept. 27. Can she now be won over by a French charm offensive (1) at repairing the relationship that was once at the heart of Europe That’s the question being asked in Paris, (2) top government officials are (3) talking about their desire to rekindle closer ties (4) their neighbors across the Rhine. (5) the end of World War II the Franco-German relationship has been the motor of European integration, the (6) force behind the creation of the European Union and, more recently, the introduction of the euro. But the ardor has (7) in this decade, particularly under Merkel, who has regularly struggled to (8) her irritation with French President Nicolas Sarkozy’s grandstanding. Sarkozy, (9) , has often been impatient with what he (10) Merkel’s lack of resolve.

The sometimes (11) personal rapport is a long way from the public shows of affection their predecessors staged, particularly Helmut Kohl and FranCois Mitterrand, who movingly held (12) in 1984 in a Verdun cemetery. There’s been tension on (13) , too. Charles Grant, director of the London-based think tank Centre for European Reform, points out that France and Germany have been (14) on issues from how best to reflate their economies during the economic (15) to the smartest strategies for dealing with Russia.

But influential movers in France are now (16) to put the relationship back on a friendlier footing. In a recent paper French think tank Institute Montaigne (17) an ambitious agenda for the two nations, (18) that a new impetus is needed if Europe’s voice is to be heard in a world (19) of big new players, such as Brazil and India, and at a time when President Obama seems fax more (20) with China and the rest of Asia than with America’s traditional allies in Europe.

11()

A.sound

B.harmonious

C.tense

D.hostile

单项选择题