Subcontracting as used in [ICH Q7, Section 16.14] refers to the contract acceptor further contracting out a specific activity to another party (third party). This should only be done when the written and approved contract, as described in [ICH Q7, Section 16.12], specifically allows for such subcontracting. Even when subcontracting is allowed, the original contract giver should approve specific subcontracting before it occurs as stated in [ICH Q7, Section 16.14].