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


The history of drug regulation has been a pattern of tragedy followed by a statutory or regulatory response: Deaths from sulfanilamide prompted the Food, Drug and Cosmetics (FD&C) Act in 1938; the birth defects caused by thalidomide resulted in the 1962 Kefauver-Harris amendments to the FD&C Act; and the Tylenol tampering incidents changed the cGMP requirements about packaging. FDA's move to a scientific approach to regulation is a tacit acknowledgment that existing regulations are not adequate due to FDA's limited resources, the increasing number of drugs and firms, and the explosive growth in knowledge and technology in some parts of the industry.2 The agency is telling industry that it needs to "know itself"— that is, thoroughly understand its products and processes. Firms need to have a formal, standardized, and rigorous process for identifying risks, determining their potential hazard, and mitigating hazards that are deemed unacceptable.

OTHER REGULATORY PLAYERS Other regulatory agencies in the US require RARMs. Among them are the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA). OSHA requires a "process hazard analysis" to evaluate and control hazards in the process,8 while EPA requires hazard assessments for stationary sources of regulated chemicals.9

Pharmaceutical manufacturers are using some forms of RARM in their safety programs. Many firms evaluate intermediates, active pharmaceutical ingredients (APIs), and final products in toxicology screens to determine the potential acute health effects (for example, dermal, ocular, inhalation, ingestion) to workers. Engineering controls or personal protective equipment is used to protect the workers from such hazards.




Other national authorities that regulate drugs use "as necessary" terminology. The Canadian GMPs note, "Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary."10 In November 2003, the International Conference on Harmonization (ICH) established an expert working group to begin writing a new document, Q9 - Quality Risk Management.11

In 2001, ISPE published a new version of its Guide for Validation of Automated Systems.12 GAMP4, as it is known, includes a process for conducting RARM on automated systems with the intended goals of avoiding any intolerable risk to patient safety or the business and to maximize the business benefits from the new computer or automated systems.13

GAMP4 recommends that risk assessment be performed at several stages during system development. One goal is to determine what validation, if any, is needed to help achieve the needed reduction of risk and maximization of benefits. The GAMP4 methodology identifies the potential risks and risk-scenarios whereby a failure or risk-event could occur. The impact (immediate and longer-term) and the likelihood of occurrence are estimated for each event. Risks can be prioritized from these estimates and risk mitigation strategies developed. GAMP4 is an example of a RARM approach that has been optimized for a specialized domain or technology.


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