The
fast-paced development of the healthcare system has seen an exodus of new
medical products and processes. Keeping this in mind the U.S Food and Drug Administration
(FDA),
as well as the European
Medicines Agency (EMA), recently issued revised guidelines. They
laid down guidance regarding Process Validation. The periodic monitoring of
product and process is known as Process Validation. Process Validation is where
recurring data is analyzed on a periodic basis and is the primary part of
process validation.
The
Process Validation is conducted in 3 stages: Stage 1 is the Process design;
Stage 2 is the Process Qualification and Stage 3 is the Continued Process
Verification. Let us understand the gist of Stage 3 – Continued Process Verification (CPV).
The data from Stage 1 which
is Product design is collected and evaluated continuously to ensure that
quality product is delivered consistently. CPV uses numerical methods to check
the process performance. It is designed in a manner wherein any undesirable
variability in the process that may happen post-launch can be evaluated. Thus,
it allows identifying any deviation from the process if any. Thus, an efficient
routine is set for Continued Process Verification throughout the life-cycle of
the product.
However, CPV is not as easy as it seems. It is marred with many challenges as
it involves a gigantic amount of data. The following are the CPV challenges
faced by pharmaceutical industries today.
Inaccuracies
in Paperwork
Many
companies used manual processes for recording data batches. Hence, they face data
entry issues, missed signatures, and incomplete details on the form. All these
delays and complicated CPV.
Importance
of Scientific Methods
The
CPV is done using the classification of statistics data using scientific
methods. Companies find it difficult to implement all these methods accurately
using traditional scientific methods.
A
humungous amount of Data
The
data needs to be collected, evaluated, and analyzed for process knowledge and
process control. However, the amount of data is huge and to observe deviations
in such a large data batch is a herculean task.
Regulatory
Issues
Due
to the usage of manual and non-standard processes, the companies face reduced
regulatory confidence. These processes are not compliant as per the regulators.
Delay
in CPV
Data
collation is extremely difficult due to the manual handling of record batches.
The paper-based batch reports cannot be synced with electronic systems. All
this leads to a delay in CPV and makes it cumbersome.
Zero
Traceability
Companies
that rely on manual CPV find it difficult to trace manufacturing changes. It is
unable to identify quality events and corrective events. They are unable to
collect information in real-time.
CPV,
not a ready-made system
Processes
and product data differ and hence ready-made solutions don’t exist. Proprietary
systems need to be developed. The real-time data solutions need quality data
and robust IT infrastructure. But such a system is difficult to develop.
Archival
of Data
CPV
also needs a reliable archiving system to store all the data batch. The
archiving system should ensure no data is lost or violated while migrating.
Such systems require high investments which Pharma companies may not be keen to
invest in.
High
cost of Automated Technologies
Many
pharma companies shy away from incorporating automated processes or
technologies due to their high cost. Hence, they continue to use manual
processes.
These
challenges are faced by 60% of pharma companies who use simple Excel sheets to
store & analyze data and there are approximately 61% of companies have data
on paper.
Conclusion
Continuous Process
Verification ensures controlled processes during manufacturing which leads to
the consistent delivery of superior life-saving products. The process of CPV is
beneficial for consumers since it protects them from any faults during
production. It is beneficial for companies as it sets quality standards that
are monitored on regular basis to ensure parameters are met with uniformity.
Also, it is extremely difficult to trace back manufacturing defects in case of
sub-standard products are produced. The CPV data helps to avoid such costly
investigations. The challenges faced by pharma companies can be eliminated once
Continuous Process Verification is done using automated Artificial Intelligence
technologies. There are various companies that provide cost-effective and
automated data batch management solutions. CPV is no longer a challenging and
laborious task with the use of new technologies, it is a risk-free approach to
improve product quality and to control the process.
Aventior offers Automated
Continued Process Validation (CPV) solution for Pharma & Biotech companies.
Their technology is a combination of Artificial Intelligence and human skill
that is used to digitize batch records. It efficiently converts unstructured
data into the required standardized format. The success records state Aventior
has successfully reduced the processing time by 300% and the cost of ownership
by 60%. To know further details about our Automated CPV solution, do email
us info@aventior.com.