In recent years, many pharmaceutical companies from the Indian subcontinent have been cited for the practice of analyzing so called unofficial, trial or demo samples.
Practice of Only Accepting Samples With ‘Passing’ Results
The general practice appears to be when a sample produces an out of specification result, it was designated as either an unofficial, trial or demo sample (depending on the company). Only results that were within specification were regarded as official, and the data retained. The raw data and laboratory records for unofficial, trial or demo samples were regarded as unofficial and discarded. Further, no investigations were carried out into samples that gave out of specification results.
This practice of only accepting results from analysis that conform to specifications and rejecting or discarding those that do not comply with specification undermines confidence in the quality of the products reaching the consumer.
Disabled Audit Trails
In addition, it was also found in some cases the instrument audit trails had been disabled. Having no audit trails on laboratory instruments undermines confidence in the accuracy and integrity of the data created from those instruments; and this will raise concerns about all of the results produced by the laboratory.
Unofficial or Uncontrolled Records
A further practice that has been identified is that of having unofficial or uncontrolled records. Here analytical information, such as sample weights, standard weights, sample and standard dilutions were recorded on unofficial forms and were only officially written up if results conforming to specification were obtained. When out of specification results were obtained the records were discarded. As with the practice of performing unofficial, trial or demo samples, this practice undermines confidence in the completeness and accuracy of the data produced by the laboratory.