Low Risk - High Risk Drugs
1.The residual limits utilized for cleaning validation are often closely related to the allergenicity/toxicity/potency of the materials in question.
2.The limits are eased when the materials being removed are generally of lower pharmacological activity.
3. At the other extreme, there are numerous materials and formulations, where even minute quantities can
have pharmacological activity.
4. The equipment and the procedures utilized to clean the
equipment might be identical, yet the production of materials with known adverse effects may require that tighter limits be achieved.
.5.Cleaning, sampling and analytical methods may need
to be refined to a high degree of sensitivity to ensure that the equipment has been properly cleaned.
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