An MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
ACCEPTANCE ACTIVITIES
The requirements of the section on acceptance activities (subpart H) replace the components, finished device inspection, and quality assurance approval requirements of the 1978 GMP regulation. The use of the term acceptance activities instead of inspection and test provides manufacturers flexibility to choose the acceptance activities most appropriate for their devices.
Receiving Acceptance Activities (820.80(b)). The requirements of this section replace those of the 1978 GMP regulation's section on components (820.80); they are more flexible and do not mandate inspection and testing as receiving acceptance activities. For example, the extent of incoming acceptance activities can be based on the degree to which the supplier has demonstrated an ability to provide quality products or services. An appropriate program might include a combination of supplier controls, incoming inspection, and testing. Manufacturers should remember that the term product includes manufacturing materials.
In-Process Acceptance Activities (820.80(c)). The 1978 GMP regulation did not mandate in-process acceptance activities; the final rule requires them "where appropriate," that is, when they are necessary to ensure that the product meets specifications.
The 1995 working draft proposed that in-process products should be "held" until the necessary verification activities or approvals were conducted. The current requirement is for the product to be "controlled."
Final Acceptance Activities (820.80(d)). The requirements of this section combine the 1978 GMP regulation requirements for finished device inspection (820.160) and those for critical devices, finished device inspection (820.161). The 1978 requirement to test devices under simulated use conditions has been moved to the section on design controls (820.30). There is no change from the requirements of the 1995 working draft.
Acceptance Records (820.80(e)). The requirements of this section are device history record (DHR) requirements. The requirements closest to them in the 1978 GMP regulation are those found in the section on critical devices, device history record (820.185). The requirement that the records include acceptance criteria, which was proposed in the 1995 working draft, has been deleted without explanation.
Acceptance Status (820.86). Although the requirements of this section were not specified in the 1978 regulation, FDA has long considered them to be a necessary element of quality assurance, and has enforced them as such. Basically, these requirements mandate that the acceptance status of products be identified during all stages of production. The requirements included in the quality system regulation are the same as those proposed in the 1995 working draft.
