Record keeping of laboratory activities is an essential requirement under Good laboratory Practices (GLP).In today’s highly overloaded laboratories there is always 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
Now the essential requirements under the above mentioned topics are discussed in detail.
Results of analytical observations
Results should be entered in laboratory notebooks concurrent to the observations made. All observations should be made using pens and pencils should never be used. 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.
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.
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.