Risk analysis of small laboratory equipment in GAMP5 environment

Weighing locations (analysis and laboratory balances, container balances, weighing balances, screening control balances) have been found in many process steps in the production and quality control of the pharmaceutical industry. Because they exist in almost every production and quality control, they are very suitable for considering the practicality of GAMP 5.
Generally speaking, they are classified into small-scale manufacturing equipment and laboratory equipment, although they completely play a role in production and quality in the process chain. Hint: Out of consideration for the following GAMP 5, we exclude 100% in-memory programmable control systems or weighing technology solutions implemented as software in PC solutions, and cannot be classified as small devices.
Separate, unconnected balances on the data side have further lost their importance, and today it has become standard to connect to the system via (bidirectional) data transmission. This may involve simple data backup, but also includes bidirectional data fusion in complex control processes. The default values ​​for traceability of process data will lead to data coupling and automatic data backup (off paper). Of course, the access rights for operation (operation phase) and setting / calibration (installation and calibration phase) must be considered. But today's access rights, which are classified, have been satisfactorily resolved even in the balance.
Depending on the use and assembly (software) of the balance will find the subordinate GAMP 5 category.
For the reasons in the balance example above, category classification should be performed. Based on existing GAMP 5 guidelines will agree on proper computer system validation (Appendix 11 of the GMP operation manual)

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