Risk Management for Aseptic Processing - Pharmaceutical Technology

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PharmTech Europe

Risk Management for Aseptic Processing
The author discusses the risks involved with aseptic processing, methods and tools used to identify and control risk, and regulatory guidelines relevant to the risk-management process.

Pharmaceutical Technology

The output of the risk-assessment portion of the risk-management process is used in the risk-control portion of the risk-management process.

Risk control. Risk control consists of developing a plan to reduce and/or accept risks. The purpose of risk control is to reduce risk to an acceptable level. The formality and effort of risk control should be appropriate for the level of risk. The following questions should be asked during this phase:

  • Is the risk level acceptable?
  • What can we do to reduce or eliminate risks?
  • What is the right balance between risks, benefits, and resources?
  • Do the risk control efforts introduce new risks?

A risk control plan may be the output of the risk control process. This plan may be included in a project plan or validation master plan, as part of the risk-communication process.

Risk communication. Risk communication is simply that—the communication of risks between decision makers and other interested parties, either within or outside the company. This may be done formally or informally, as appropriate for the risk level of the product and process.

Risk review. Risk review is simply periodic review of risks as part of the ongoing quality management process. Examples of where formal or informal risk review might be performed include periodic management review, as part of a change control program or as part of annual product reviews. However it is performed, risk review should be integrated into the quality-management system.

Risk-assessment tools

The following is a partial list of some of the risk-assessment tools used in the pharmaceutical industry. This is hardly a comprehensive list. There are numerous risk-assessment tools available in different industries and for different functions within the same industry.

Figure 2: 3-D risk assessment matrix (4). (FIGURE 2 IS COURTESY OF THE AUTHOR)
3-D risk assessment. Three-dimensional (3-D) risk assessment is a risk assessment tool that takes into account a system's distance from the process stream, its location along the process stream (e.g., active pharmaceutical ingredient [API] synthesis, and purification, bulk product formulation, sterile filtration, filling and stoppering, etc.), and the system's complexity (4). This tool is mainly used to assign a risk level to an overall system. Where appropriate, additional risk assessment tools may be used to evaluate risks within a pharmaceutical system. Figure 2 gives a visual representation of the 3-D risk assessment process for a biotechnology-derived product (4).


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