Page 36 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

GMP rules and cleaning

The GMP rules are very explicit regarding the requirement to clean and sanitize
equipment and the manufacturing facility.

Since most residues cannot be seen nor reliably tested tor, the company's
standard procedures and cleaning records are relied upon as evidence of
cleaning.

GMP CLEANING

GMP requires the cleaning procedures to be fully
documented in written procedures. These procedures

CLEANING are initially validated (shown to be effective)
PROCEDURES specifically for an item of equipment or on area.

Once validated, the procedures are then published
and used.

All cleaning procedures should be validated (shown
to be effective) under specific conditions of use. These
conditions of use ore specified in the written
procedure.

If employees alter the conditions of use, the cleaning
methods may be "invalidated" and may not be
CLEANING effective, for example, it would seem logical that
VALIDATION
adding more sanitizer than the procedure requires
would make cleaning faster or better. This is not
always the case. Adding additional sanitizer may
alter the pH of the cleaning agent and make it less
effective.
The relevant GMP rules are to only clean under
validated conditions, and to follow procedures
exactly.

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