Page 37 - Cleaning and sanitation in GMP
P. 37
GMP Training – Cleaning and Sanitation in GMP Areas by www.gmpsop.com
SOME CRITERIA FOR CLEANLINESS CAN BE
Visual inspection should always be used irrespective of
Visually other methods employed. Visual inspection should occur
clean both post-cleaning and again before next use of the
equipment.
<0.1% This limit is sometimes used as a default limit because it
detected is less than 1/1000 of the previous active chemical in the
next batch.
Certain per This limit is similar to the <0.1% limit. A general guide for
million this limit is not more than 10ppm carryover to the next
detected
product.
No product Sometimes this limit is used when the allowable carryover
detected of residue is higher than the limits of the analytical
method being applied.
This limit is applied to microbial residues post-sanitation.
No microbial While there is no specific limit required in regulations, the
activity limit chosen should reflect that product risk. For
detected
example, for sterile products the limit is nil, while for
tablets it may be higher.
GOOD TO KNOW - ISSUES IN EQUIPMENT CLEANING VALIDATION
Other issues to consider when validating equipment cleaning include:
using the active ingredient as a marker
considering all components of the product (not just the active)
ensuring that the analytical detection methods have been validated
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