替代第二人复核

beiwei5du

原料药生产过程中，很多时候是在控制面板上进行处理或是控制的（比如发酵自控系统）。操作者坐在控制间按着按钮来向反应耀中添加物料，可以想象’如果操作者必须
跑到反应罐边去确认物料是否真的加到反应罐中去了’是非常不方便的。所以在这里提到“类似”控制手段。类似的控制可能是通过打印出来的记录来显示，例如加了多少量的物
料。在原料药生产中，很多工艺是在密闭的系统中进行，很多时候很难有第二个人去复核某个特殊的操作，然后在批记录上签名，这也是GMP允许“类似方法控制”的原因之一，
ICH 指南中也有类似的说法。对于第二人复核替代的问题，可以参考FDA有关CFR211修改时的解释以获得更多的解释，解释中明确说明只有替代用的自动化设备满足§ 211. 68中的要求，方可用来替代第二人审核。

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C--DRUGS: GENERAL

PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart D--Equipment

Sec. 211.68 Automatic, mechanical, and electronic equipment.

(a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained. (b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained. (c) Such automated equipment used for performance of operations addressed by 211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11) can satisfy the requirements included in those sections relating to the performance of an operation by one person and checking by another person if such equipment is used in conformity with this section, and one person checks that the equipment properly performed the operation. [43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995; 73 FR 51932, Sept. 8, 2008]