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Electronic
Audit –
TM-II provides audit trail capability at the application level
with secure, computer generated, time-stamped audit trails
that record the date and time of operator entries and
actions that modify or delete entries. “AuditMaster_Product_Sheet.pdf”.
Date
& Time Stamps – Application
level, password protected access to date and time stamp
information is viewable on-screen for most tables. Determine
immediately, the most recent date, time and user to modify
every record in a table. Electronic Audit functions provide
additional capability as described above.
User
Login & Password Security – Both
application and database password protection ensure that
only authorized individuals can use the system, access
the operation, alter a record, or perform the operation
at hand. The TM-II application includes twenty-six (26)
different “rights” that can be assigned to or removed from
each user ID. TM-II provides an option
for Windows Authentication that allows a network
administrator to have complete control over the TM-II Login ID
and password. For more information see the product sheet
document “Security_Solution_Sheet.pdf.”
Simplified
Tool Inspections – With
every measurement you include in your inspection SOP, the
FDA may want see evidence of: training; validation;
calibration; etc. In other words, why open a can of worms? The
TM-II system recommends that you ONLY INSPECT CRITICAL
DIMENSIONS!
The following
represents the recommendations of Natoli Engineering
Company, Inc. for the proper approach to dimensional
inspections of upper and lower punches in order to assure
tablet quality. The recommendations are based on dimensions
that provide consistency with regard to tablet hardness,
weight and thickness.
Punch Inspection
Critical Dimensions – We believe there
are three (3) critical dimensions that should be included
in a dimensional inspection of an upper or lower punch. Measuring
any other dimension is either A) unnecessary because it
rarely, if ever changes and therefore is not worthy of
the time and expense of measuring or B) cannot be properly
measured with current equipment and is better served by
a visual inspection.
The three (3) critical dimensions include the following:
1.) Working
Length – The working length is the most critical
punch dimension because it determines tablet thickness
and hardness. Tolerances should be based on the measurement
of a punch in relation to other punches as opposed to being
based on a specific length. Uniformity of punch working
lengths is the key. In other words, as long as the punches
are the same length (or within the specified tolerance)
it doesn’t matter how they compare in relation to a specific
pre-defined length.
2.) Cup Depth – To find the cup depth, subtract the measured
working length from the measured overall length. Cup depth
is not a critical dimension with regard to controlling
tablet weight.
3.)
Overall Length – The overall length
is not critical except that it is necessary to accurately
calculate Working Length and Cup Depth. In other words,
you should not always assume a 5.250” overall length measurement.
For additional
reference, please see the “Encyclopedia
of Pharmaceutical Technology” Volume 15 pp. 168 –169 and “Tableting
Specification Manual” Sixth Edition pp. 13, 14 & 15.
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Database
Security