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October 1999


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"Harder, Joel" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Tue, 19 Oct 1999 09:42:49 -0400
text/plain (72 lines)
My understanding that highlighters are not allowed because of the potential
interference these could have when photocopying (i.e., FDA inspectors may
request copies of files). In some cases, the highlighter can smear the ink
and ruin the original record.

Black ink was required when the day and age that photocopier quality was
low- red and blue did not pick-up via photocopying as well as black.

In the Human cGMP Notes by Paul Motise, September 1997- here is some
interpretation regarding color of ink.

Does FDA have any guidance regarding the color of ink used to prepare CGMP
production records?

Reference: 21 CFR 211.180, General requirements, Subpart J, Records and

No. However, whatever ink is used should permit the records to meet the
inspection, review and archiving
requirements in section 211.180 of the CGMP regulations. For example, for a
record to be maintained for one
year past the expiration date of the related lot, per 211.180(b), one needs
to be able to read the record
throughout the retention period. Likewise, per 211.180(c), the records are
subject to FDA photocopying or other
means of reproduction. In addition, paragraph (e) of this section requires
that production records be maintained
such that firms may review them at least annually to determine if production
and control changes need to be
made. Keeping these needs in mind, the ink that fades, can't be copied or
otherwise obscures information
would be troublesome.

Contact for further information: Richard S. Lev, HFD-325, 301-594-0089,
e-mail: [log in to unmask]

Joel C. Harder
* v-mail: 703-351-5942
* e-mail: [log in to unmask]

-----Original Message-----
From:   rfriedel [mailto:[log in to unmask]]
Sent:   Monday, October 18, 1999 9:07 AM
To:     [log in to unmask]
Subject:        [PMFLIST] Use of Highlighter in Raw Data

 << File: Part.001 >> My position regarding the use of highlighter in the
laboratory notebook is that it should NOT be used.  My past GMP training
stated that only black ink be used to document raw data.  One of my
colleagues disagrees.  I would like to hear from the group and if possible
please provide a GMP citation which I could reference.  Thanks for the

Robert R. Friedel
Quality Assurance Manager
Laboratory Research & Analysis Groups
Perritt Laboratories, Inc.
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