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www.safcpharma.com
ProClin
®
Preservative
for Diagnostic Reagents
Packaging Information
 
SAFC Pharma
®
pipeline partners
Who is setting the rules?
When dealing with highly potent compounds, it’scritical that failsafe procedures are in place relating totheir handling, storage and containment. In order toensure that the correct procedures are installed andadhered to, a logical system of classifying the potencyof the High-Potent API (HPAPI) is needed. At present,
there is no ofcial guidance regarding the safe
handling of highly potent APIs. As a result, the industryhas begun self-regulating itself, with standardsdeveloped by SafeBridge
®
Consultants(http://www.safebridge.com) being the most widely recognized
classication system.
Origins of the issue
The lack of a single, commonly used system forclassifying HPAPIs can be traced back to the end of the 1980s, when pharmaceutical companies initiallybegan discussing the safety issues around HPAPIs andhow they might classify them. One idea consideredat the time was the introduction of a system similar tothe biosafety level approach developed by the Centersfor Disease Control in Atlanta, Georgia. This systeminvolved a four-level system of pathogenicity, with eachlevel designated an appropriate level of containment.This initiative was ultimately unsuccessful and theidea of developing and implementing a united, singlesystem for classifying HPAPIs across the entirepharmaceutical industry lost impetus, primarily due to
the signicant variations in areas of therapeutic interest
and manufacturing procedures among the companies.What emerged instead was the general concept of 
HPAPI classication (or banding), which was, in turn,
adopted and customized by individual companies
to meet its own specic requirements. The upshot- the current diverse range of classication models
witnessed today.In practice, the four-tier system discussed initially bypharmaceutical companies evolved over time to formthe basis of the SafeBridge system. As mentionedearlier, this system is now well-established and widelyaccepted among CMOs. SafeBridge’s system involvesranking a compound for potential potency and toxicityon a scale of I to IV. Category I covers low-irritantdrugs, while Category II, currently the largest, includesdrugs that can cause organ toxicity. Category III is the
rst tier of potent drugs that cause genetic effects,plus organ toxicity, and nally, a tier Category IV, of the
most potent compounds. According to SafeBridge, anincreasing number of new drugs under developmentfall into the latter two categories.The following are attributes that may be considered foreach category of compound:
Category 1:
Low potency, higher dosage levels,minimal reversible acute/chronic health effects, goodwarning properties, no “genic” effects, not a sensitizer,
slow absorption, no medical intervention required
following exposure.
Category 2:
Moderate acute/chronic toxicity, reversibleeffects, weak sensitizer, fair warning properties,moderate absorption rate, no “genic” effects, may
require medical intervention.
Category 3:
Elevated potency, high acute/chronictoxicity, effects may not be reversible, moderate
sensitizer, poor or no warning properties, quick
absorption rate, suspected or known “genic” effects,
moderate to immediate medical intervention required.
Category 4:
High potency, extreme acute and chronictoxicity, irreversible effects, strong sensitizer, poor or
no warning properties, quick absorption rate, known
“genic” effects, higher degree of medical intervention
required, may affect sensitive subpopulations.
David Bormett, Director, Operations
Potency classifcation scheme
Category I Category II Category III Category IVOccupational exposure limit (µg/m3) >50010-5000.03-10<0.03Toxicity and potency LowModeratePotentHighly Potent
High-Potent API Classication
 An introduction to
Source: SafeBridge Consultants
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