Errors in Pharmaceutical divided into two different portions, namely : (a) Errors in Pharmaceutical Analysis,
and (b) Statistical Validation, which
will be discussed individually in the following sections :
ERRORS IN PHARMACEUTICAL ANALYSIS
The skill, knowledge, expertise and above all the degree
of confidence involved in the ultimate result of an analyst is solely governed
by the extent of accuracy and precision achieved by the analytical procedure vis-a-vis the possible sources of error
that may be incorporated inadvertently. In fact, the quantitative pharmaceutical analysis is not merely
confined to just taking a random sample, performing a single assay quickly, and
finally making a loud claim that the result so obtained cannot be challenged.
Truly speaking an ideal analyst must have a total in-depth knowledge of the
chemistry involved along with the pros
and cons of interferences that may be caused due to the host of compounds,
elements and ions besides adequate exposure and hands-on experience of the
statistical distribution of values.
The terminology ‘error’ invariably refers to the
difference in the numerical values between a measured value and the true value.
It has become universally accepted in methods of comparison that the percentage
composition of a ‘standard sample’ provided and certified by the National
Institute of Standards and Technology (NIST) or the British Pharmacopoea
Chemical Reference Substance (BPCRS) or the European Pharmacopoea Chemical
Reference Substance (EPCRS) must be regarded and treated as absolutely correct,
pure and authentic while evaluating a new analytical method. Consequently, the
differences thus obtained between the standard values and those by the new
analytical methods are then treated as ‘errors’ in the latest procedure.