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Question of the Week

Packaging process: How can in-process controls be organised?

Various organisational systems are used for in-process control during the packaging process. One possibility is the assignment of functions and responsibilities to different groups. This involves functional tests and routine checks being carried out by production staff during the actual production process. A start-up control, i.e. a detailed check of the first goods produced for the order as well as the line release is carried out by a group which reports directly to either the quality control manager or QA to ensure that an independent decision is reached. These groups, also referred to as line inspectors or monitors (depending on company terminology), can also carry out tests throughout the packaging process, including functional tests. The responsibilities for the various tests must be clearly specified in each instance to avoid misunderstanding.

Responsibilities during in-process controls
  • Production personnel: Operational tests and routine process controls
  • Line inspectors: Release for production, tests on (partially) packaged goods
[GMP MANUAL, Chapter 13.B.5.5]

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