BS ISO 18362:2016 pdf free
BS ISO 18362:2016 pdf free.Manufacture of cell-based health care products – Control of microbial risks during processing
For materials used during processing of CBHPs, consideration shall be given to the prevention, removal or inactivation of contaminants during the risk assessment process.
a) A risk management process shall be established and implemented according to ISO 14971 and ICH Q9.
b) Risk assessment shall be conducted to identify and evaluate risks associated with the processing and risks associated with the specific CBHP, and to understand interaction of these risks. The results of risk assessment shall be used as input for risk mitigation measures and to design process simulation and process confirmation studies.
NOTE 1 Intrinsic biological contamination risks caused by cell-based starting materials and their contribution to inter-batch cross contamination risks are of major importance in the processing of CBHP.
NOTE 2 Risk management tools can be selected and employed throughout the life cycle of the product, for example, in the product and process design, development and validation stages.
c) Measures to control process risks for the manufacture of CBHP shall be defined and implemented.Residual risks deemed to be acceptable shall be documented and justified.
Based on the CBHP process definition an assessment of processing risks shall be conducted.
Methods and/or procedures to minimize and control these risks shall be described and implemented (see 5.2). Residual risks shall be justified.
NOTE 1 Examples of specific process risks associated with CBHP include: use of starting material with intrinsic biological contamination, insufficient inactivation [or selective enhancement) of intrinsic biological contamination, ingress of extrinsic contamination, inactivation of biological activity and accidental release of hazardous material from a containment facility.
NOTE 2 Examples of specific contamination risks for CBHP are given in Annex A.
The process definition shall consider the complete process and give a rationale describing how each element involved in processing contributes to the attainment of product specification. The process definition shall be documented and approved by designated personnel.BS ISO 18362 pdf free download.
