IoT-Enabled Global Process Validation System
For a better demonstration of APC capabilities of a desired IoT-enabled process validated system , we have considered the “ Pharmaceutical Tablet Formulation manufacturing ” use case in this paper . The proposed use case IoT solution capabilities can also be extended to “ Vaccines ” manufacturing due to the fundamental similarities between chemical drug manufacturing and biologics drug manufacturing processes such as - the nature of in-process quality control ( IPQC ) tests throughout upstream and downstream processes , similar production systems such as MES & LIMS and most importantly compliance with the regulatory requirements of FDA ’ s cGMP practices .
USE CASE : PROCESS OPTIMIZATION FOR TABLET FORMULATION MANUFACTURING
A typical “ Tablet Formulation ” manufacturing process has multiple unit operations such as milling , mixing , blending , discharge or compression , coating , etc . It also includes multiple inprocess quality control ( IPQC ) tests 6 that are carried out by the quality team on the processed output at the end of every unit operation such as testing for “ content uniformity ,” “ lending homogeneity ,” “ dissolution rate ,” etc .
Since these IPQC tests are executed separately in the laboratory environment on the intermediate and finished samples collected from the batch under production , the quality control experts end up spending significant amount of their time to accurately determine if the IPQC tests meet all the batch acceptance criteria or not .
For example , a “ dissolution ” IPQC test involves placing each tablet from the sample into a dissolution medium that simulates human digestive fluids and record the percentage of dissolution of the tablet over a duration of 1 hour . In case the actual dissolution rate is higher than the minimum acceptable dissolution rate , the batch will be accepted or else it will be rejected . Such rejected batches not only lead to material loss in the form of scrap but also lead to production delays due to rework that is associated with a new batch production .
In case a detailed Root Cause Analysis ( RCA ) and Corrective and Preventive Actions ( CAPA ) are not implemented between the failed batch and the new batch under production , there is a high probability that the new batch may also fail the impending IPQC tests . This means that the quality team would be investing considerable amount of their time on conducting the IPQC tests on the new batch which are bound to fail leading to high scrap , rework and further production delays .
- 44 - November 2020