1.5 - Risk Assessment or QRM quality control Representative samples of each shipment

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

Any physical plant you use in the manufacture

quality and purity

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

3 years after distribution of the batch

1.5 - Risk Assessment or QRM quality control Representative samples of each shipmentQuality 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