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参与药品研发过程的每个组织都必须熟悉适用的GMPs并知道处于研发过程的哪个阶段（1-4） Areas to be reviewed to determine the appropriate level of control needed in concert with the phase development stage include: level of validation of test methods, level of detail needed in batch records, level of control needed on incoming materials, and facility and equipment controls. An example is qualifying raw materials. In Phase I/II of the development process, you may only decide to document the source and quality of the material used to produce the product; when you enter into Phase III you will want to qualify your supplier and establish a quality agreement in addition to the material qualification. 为了确定不同研发阶段的控制水平，需要进行评审的领域包括：检验方法的验证水平，批记录的详细程度，物料的控制级别以及设施和设备控制。一个例子就是确认物料。在研发过程的第一阶段/第二阶段，您只需要记录用于生产的物料的来源和质量; 当您进入第三阶段时，您将需要对供应商进行资质确认，并建立质量协议。 Although not all GMP requirements apply to products in the early stages of development, the requirements for change control and deviation investigation should be robust and utilized at all stages of product development. The information documented in change control and as part of an investigation helps ensure that process improvements are efficient and do not repeat strategies that were discounted during earlier stages in the development process. It also helps to capture the product and process history needed in the later phases of development for the process validation activities. 虽然并非所有的GMP要求都适用于研发早期阶段的产品，但对变更控制和偏差调查的要求应该是稳健的，并应用于产品研发的所有阶段。变更控制和调查中记录的信息有助于确保工艺有效改进，并且不会重复在研发过程的早期阶段被打折的策略。它还有助于捕获工艺验证活动开发后期所需的产品和过程历史。 To determine the impact of the deviation on the product quality, it is important to determine the ‘root cause’ of the deviation. The process used in the industry to determine root cause is, of course, the investigation procedure. This procedure, regardless of whether the product you are investigating is biotech or traditional, or new or old, should require the investigator to review various systems and determine whether they were the cause of the deviation being investigated. It is important to keep in mind that change control and deviations are critical elements for ensuring product quality and patient safety regardless of the stage of development a product is at in the product lifecycle. 为了确定偏差对产品质量的影响，确定偏差的“根本原因”很重要。行业中用来确定根本原因的过程自然是调查程序。无论您正在调查的产品是生物技术还是传统产品，或者是新的还是旧的，都应该要求调查人员检查各种系统，并确定他们是否是造成偏差的原因。记住变更控制和偏差是确保产品质量和患者安全的关键要素，无论产品处在产品生命周期中的哪个开发阶段。     公众号 GMP办公室 
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