Biomedical Engineering Reference
In-Depth Information
11.3.1 Risk-Based Approach Management Tool: What is HACCP?
Hazard analysis and critical control points (HACCP) is a worldwide-recognized
systematic and inductive tool that can address biological, chemical, or physical
hazards through anticipation and prevention, rather than through end-product
inspection and testing. The approach is to control identified critical processing
parameters as the product is being manufactured [14]. It can be used as a way of
identifying and controlling microbial risk for the production of pharmaceuticals
that are not required to meet the test for sterility.
11.3.2 History of HACCP
HACCP has its roots in food safety and was first developed and used by the Pills-
bury Company in the late 1960s to provide safe food for the United States space
program, NASA. The program focused on applying science-based controls to
prevent hazards that could cause food-borne illnesses. In 1973, the United States
Food and Drug Administration (FDA) instituted mandatory HACCP programs
for juice, for low acid canned food processing and in 1997 for seafood proces-
sors. The United States Department of Agriculture (USDA) instituted mandatory
HACCP programs for meat. EU member states have also adopted HACCP for
food safety. ICH Q9, “Quality Risk Management” listed HACCP as a primary
tool for risk management.
11.3.3 Benefits of HACCP for Microbiological Control
In the past, periodic inspection and environmental testing were used to ensure the
quality and safety of the product. However, they provide information about the
product that is only relevant for the specific time of the inspection or testing, and
microbiological test results would not be available in real time. HACCP provides
a system to control safety as the product is manufactured rather than trying to
detect problems by testing or inspection. HACCP identifies critical control points
(CCPs) within the process in which a microbial hazard could have an impact on
final product quality.
A drug product is defined by physical, chemical, or microbiological character-
istics or attributes. When these characteristics or attributes impact product quality
or safety, they are referred to as critical quality attributes ( CQAs ). These product
attributes may be impacted by the processing steps during the manufacturing pro-
cess. Those process parameters, whose variability may impact a critical quality
attribute, are referred to as CPPs . By definition in ICH Q8 (R2), Pharmaceutical
Development , the critical quality product attributes should be within established
specifications to ensure product quality and the critical process parameters should
be controlled. By applying “control” at the CCP, the amount of total process mon-
itoring should be minimized and the value of the activities maximized. It provides
just in time control rather than after the fact.
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