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May 2011

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Subject:
From:
Nicoline Bæk <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 23 May 2011 08:35:06 +0200
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Would like to hear what types of equipments generelly are defined as "Major
equipments" ??
-and "Production equipment" ?

-This is mostly related the interpretation of which equipments the demands
regarding registration in the logbook of any use and double signature for
cleaning, service and maintenance is to be applied for ???

-as defined in the US CFR §211.182.
"A written record of major equipment cleaning, maintenance, and use shall be
included in individual equipment logs that show the date, time, product, and
lot number of each batch processed......
The persons performing and double-checking the cleaning and maintenance
(...) shall date and sign or initial the log indicating that the work was
performed........".
And
EU GMP Guide Chapter 4.31 Documentation.
"Logbooks should be kept for major or critical analytical testing,
production equipment, and areas where product has been processed. They
should be used to record in chronological order, as appropriate, any use of
the area, equipment/method, calibrations, maintenance, cleaning or repair
operations, including the dates and identity of people who carried these
operations out".

-Additionally, is this generelly also consider to apply for monitoring
equipment like particle counters and airsamplers?

KR
Nicoline Bęk
Chemist, Environmental department

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