您按照药品GMP(2010年修订)的要求适当进行工艺验证了吗？
Do you perform a process validation properly according to GMP Guidelines (revised in 2010)?
激光相变强化工艺参数的硬化层特性影响较大，在产品应用之前必须进行工艺验证。
The technological parameters of LTHT can affect the characteristics of hardening case, so verification must be conducted before applying the product.
不需要，不论cGMP法规还是FDA的政策都没有指定进行工艺验证的最少批次。
No. Neither the CGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process.
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