Good Documentation Practices fall under the scope of Good Laboratory Practices. GDP helps to streamline laboratory operations and preservation of evidence of all activities conducted in laboratories. In essence, GDP is concerned with records of experimental observations and control of documents.
Documentation of Observations
It is mandatory for laboratories to maintain records of experimental observations for the purpose of communication of results. Such records include:
- Experimental observations and related data
- Periodic records of environmental conditions such as temperature, humidity, atmospheric pressure and light illumination.
- Record of calculations and factors used in calculations
- Weight records
- Supporting data such as spectra, chromatograms, thermograms, etc
- Instrument logs
- CRM and working standard records
Mandatory Documentary records
It is not sufficient to keep records of experimental observations but it is equally important to exercise control and maintain laboratory documents which include:
- Quality management manual
- Laboratory notebooks
- Standard Operating Procedures and Standard Test procedures
- Material safety data sheets
- Calibration and maintenance records of instruments
- Training and validation records of laboratory analysts
- Test sample storage and disposal records
- Effluent treatment and laboratory waste disposal records
The list is virtually unending and can include records pertaining to the nature and scope of activities being carried out.
When is GDP to be followed?
The answer to this question is that GDP is to be followed at each and every stage in all laboratory departments:
- Purchase Department has to make records of indents, a record of entries at the time of receipt and issuance of chemicals, glassware, consumables, labels, test instruments, spares, etc.
- Section heads have to maintain records on receipt of test samples, distribution of samples to different analysts, start and end times of analysis, obtained results and disposal of samples after analysis.
- Housekeeping and maintenance sections maintain records of maintenance of laboratory utilities and logs on a number of times sweeping and mopping is carried out daily in laboratories and general use areas.
- Health officer has to maintain records of periodic medical checkups of chemists to make sure that they are not suffering from communicable diseases or have any open wounds and are fit enough for performing their assigned duties.
- Quality assurance maintains a record of issue, review, and disposal of laboratory documents. The quality assurance department has overall responsibility for implementation of processes and authorized test procedures for the upkeep of laboratory’s quality policies.
Current versions of all documents such as SOP’s, STP’s, Audit reports, training records, Corrective and Preventive actions, analysis reports, calibration and maintenance records of instruments, instrument logs, on procurement and consumption of certified reference materials, stability studies records, etc prove to be of immense help under following situations:
- External audits
- Disputes arising from reported results
- Submission of research work for publications
- Upkeep of safety standards in laboratories
- Time-saving as the procedures are standardized and validated before adoption and no time is spent on hit and trial for routine daily activities.
- Serve as training tools for new entrants
- However, depending on changing requirements and adoption of emerging technologies the documents and guidelines can be reviewed and revised.
Benefits of e-records
Today advances in Information technology are making inroads in all sectors and laboratories are not lagging behind. Documentary records are being fast replaced by e-records. The benefits offered through the adoption of e-records are highlighted here:
- Paperless work environment saves precious laboratory space.
- Multi-user access helps take timely corrective actions.
- Preservation of critical data in soft copy formats.
- Audit trails prevent tampering by unauthorized persons.