1.5 - Risk Assessment or QRM quality control quality and purity

quality and purity

3 years after distribution of the batch

one investigation per OOS test parameter

Any physical plant you use in the manufacture

Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination

1.5 - Risk Assessment or QRM quality control quality and purityQuality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The level of effort, formality and documentation of the quality risk management process is