1.5 - Risk Assessment or QRM quality control 3 years after distribution of

3 years after distribution of the batch

and dispose of trash in a manner that minimizes the development of odors

Representative samples of each shipment of each lot shall be collected for testing or examination

Returned or reprocessed drug product shall be destroyed unless examination

1.5 - Risk Assessment or QRM quality control 3 years after distribution ofQuality 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