Good Laboratory Practice - List of records to maintain
Record
keeping of laboratory activities is an essential requirement under Good
laboratory Practices (GLP).In today’s highly overloaded laboratories there is
alway
s an argument that maintaining records is a drain on time which could be
otherwise utilized for carrying out analysis activities.
The article
makes suggestions on record keeping and outlines advantages derived from
keeping such records. It has been quoted several times ‘If you have not
recorded it, you have not done it.’ One realizes the significance of this
statement when one faces auditors from regulatory bodies.
What all
activities need to be recorded?
Record
keeping is commonly considered to be an additional burden which cuts down your
time available for analysis activities but after going through the article you
will start believing otherwise and realize the importance of maintaining
laboratory records. Now the question arises – Which laboratory activities need
to be recorded ?
- Results of analysis observations
- Document issue and control
- Environmental record of
laboratory
- Calibration and Maintenance
record of instruments
- Log records
- Training records
Below is the detail discussion of the
essential requirements of the above mentioned records.
Results
of analytical observations
Results
should be entered in laboratory notebooks concurrent to the observations made. Support documents such as spectra, chromatograms, etc should be stored
separately. Weight slips should also be initialed with date and preserved in a
likewise manner. Calculations based on observed values should be shown for reference
purpose and re-verification of results.
Document
issue and control
It should be
ensured that only valid documents are available for use by laboratory analysts.
All obsolete documents should be retrieved and properly disposed off.
This
requires strict control over release, withdrawal and disposal of documents such
as SOP’s and STP’s
Environmental
Conditions records
Environmental conditions such as temperature and
humidity are necessary for conducting analysis and ensuring long service life
of analytical instruments.
Exposure to correct light intensity is also
necessary for optimum control over light sensitive materials and reactions.
Record keeping of such conditions is therefore a necessity. Such records are
also helpful for re-verification of results and to ensure that the instruments
work under specified conditions. Authentication of analysis conditions is an
essential requirement of regulatory agencies.
Calibration
and Maintenance record of instruments
The results
of any analysis are reliable only when the instruments are properly maintained
and calibrated as per supplier recommendations. SOP’s serve the required
purpose. Calibration observations and supporting records also deserve to be
preserved for reference at any point of time.
Log
records
Logs are
tamper- proof records on laboratory instruments, environmental conditions and
consumption of critical laboratory supplies. It is mandatory to maintain
separate record for each instrument. Further separate records are needed- one
for instrument history and the other for its usage. The history record
essentially includes date of purchase, date of instrument arrival, system
configuration and software details, maintenance and calibration records,
up-gradation with accessories and newer software versions and listing of
authorized users with specimen signatures for subsequent verification.
The usage
record covers details such as date of use, name of user, start and end time,
name of sample analyzed, quantity weighed in case of analytical balance and
remarks if any unusual behavior is noticed. The information available in logs
proves to be a great help in diagnosing faults at time of breakdowns.
Logs are of
immense use in evaluation of utilization of instruments for working out their
cost to benefit ratios, justification of costs incurred on maintenance and
servicing, verification of use by authorized users and as supporting documents
during audits.
It is
equally important to keep logbooks in close vicinity of instruments as
non-traceability should not be used as an excuse for non-updating concurrent
with the activity performed.
Training
Records
Regular
training and up-gradation of skills are necessary for smooth and efficient
operations, prevention of mishaps and for optimum use of skilled manpower .It
is also an essential requirement for granting authority for handling of
sophisticated analytical instruments and for meeting the basic requirements stipulated
by regulating bodies..
In
conclusion it can be said that laboratory records help maintain high standards
of laboratories and also sustain the trust of customers on results communicated
by such laboratories.
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