Faced with the current challenge of companies being accredited with the GMP Certification, there is a need to comply with parameters established by pharmacopoeias.The need to have consolidated and updated pharmacopoeias gives great importance to this aspect in SAP, given that they include the standards, quality requirements and technical information of raw materials for pharmaceutical use made available to citizens.
The importance of the pharmaceutical sector at a global level requires a SAP tool which manages the multiple existing pharmacopoeias.To do so, the multiple specifications are an important instrument when indicating if the results of an inspection are plausible for different pharmacopoeias, being able to reject certain drug items for a particular destination.In addition, such multiple specifications can be used beyond pharmacopoeias.
Multiple specifications for pharmacopoeias
In the case of multiple specifications applied to pharmacopoeias, first the pharmacopoeias to use must be chosen, for example:
-DAB: German Pharmacopeia
-USP: The United States Pharmacopeia
-NFXI: National Formulary XI Edition
The association of a material characteristic to which the pharmacopoeia is associated is required.In the case of pharmacopoeias, an example could be the pH or the viscosity of a drug, which can be regulated according to regions or countries depending on the corresponding pharmacopoeia..
In addition, for the chosen material along with its assigned pharmacopoeia, both theoretical and tolerances values that are accepted according to each pharmacopoeia, must be assigned.If instead of pharmacopoeias there were other types of objects such as countries, they must also relate to the material and the desired feature.
After the creation of multiple specifications, when generating an inspection lot we have a new tab in the results record with the multiple specifications created for this material.In this tab, if we have specifications for different pharmacopoeias, we can see that depending on the results obtained for the characteristic in question, the batch will be accepted or not for each of the pharmacopoeias.
In the present case, if the viscosity value were 19 mPa.s, the batch would be accepted for the American and German pharmacopoeias, but not for the National Formulary (NFXI).This section also shows the theoretical values and tolerances of each of the pharmacopoeias for each inspection characteristic.This is the beneficial value obtained from multiple specifications, and means that if the viscosity value were modified, the batch could be accepted or rejected depending on the limits of each of the pharmacopoeias..
As demonstrated, this is a powerful tool for the pharmaceutical sector since it allows the possible rejection of inspection batches depending on the destination or the documentation associated with the characteristic itself in a fast way.Furthermore, it can be useful in other fields given the varied the type of object to define multiple specifications such as: country, pharmacopoeia, customer, degree of hazard, etc.Being so customizable, it allows valuation of the inspection lot depending on any type of specification that the user wishes.
In view of the above, SAP has a key role in the field of pharmaceuticals, given the management of the inspection lots through the pharmacopoeias with multiple specifications, being only a small part within the role of SAP in this sector, plays an important role within it.