Assessing and Managing Risks in a GMP Environment - Investing time and resources into conducting a risk assessment on a process or product can have a variety of benefits. Save your firm from

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Assessing and Managing Risks in a GMP Environment
Investing time and resources into conducting a risk assessment on a process or product can have a variety of benefits. Save your firm from regulatory headaches by making risk management part of its culture.


BioPharm International


BENEFITS OF A RARM PROGRAM Investing time and resources on a RARM for a process or product has a variety of benefits, the most significant of which is reducing potential sources of risk to acceptable levels. If an accident or failure occurs, a properly conducted RARM helps assure that the impact to people, the organization, and the environment is considerably less than if an analysis was not done and no controls were in place. When a mitigation plan is used, for example, people are protected because they wear protective equipment or a back-up supplier of a critical raw material has been identified. Intangible benefits that are important in today's regulatory and business climate also include being able to react in a standardized and organized way that gives confidence to regulatory agencies, shareholders, and those watching through the lens of the media.

Occasionally, RARM yields an additional, serendipitous benefit. For example, one drug firm replaced methylene-chloride-based tablet-coating with a water-based procedure. Initially implemented to improve workplace health and safety, the substitution also significantly reduced costs, reduced air emissions, and simplified waste treatment. These "win-win" situations are rare, but they do occur.

CONNECTING RARM TO QUALITY SYSTEMS Tools for assessing and controlling risk should have an important place in the quality system of a drug or biologicals organization. Product and process development groups are key in providing data used in RARM. This was acknowledged by the ICH, which established another expert working group to develop "Q8 — Pharmaceutical Development."14 Key data include product quality attributes, specifications, and the critical processing parameters that must be met.

Firms that are establishing new facilities, products, or processes should use RARM. Interdisciplinary teams will evaluate potential process flows and select processes and materials that are known to run more consistently and with fewer potential hazards. Once a process is selected, a team can perform a more extensive RARM, identify possible failures, and define ways of preventing or recovering from such failures.

Technology transfer can also benefit from a formal RARM. While the development reports found in technology transfer packages usually identify critical parameters and ranges (that are later validated), they often do not provide detail about potential adverse events, especially those considered highly unlikely. Using a process like HazOpS (described) forces one to answer these questions and helps ensure that the RARM was thorough, complete, and well documented.

RARM can be integrated into a change management program. Most firms today include some aspects of RARM but often in a cursory, informal way. Using a formal RARM methodology forces the reviewers to rigorously consider potential impacts, how to prevent or control (mitigate) them, and ways to monitor the product or process to ensure that the control measures are effective. FDA's Scale-Up and Post Approval Change (SUPAC) initiative is an example of this approach, calling for more controls and monitoring (and regulatory agency involvement) as the scope and complexity of the change increases.15


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