The Pharma industry is one of the most regulated and controlled sectors in today’s fast-moving competitive economy. It is subjected to number of regulations and compliance mandates stipulated by various regulatory authorities (FDA, EMA and others). These mandates enforce strict quality processes and standards on pharmaceutical companies to ensure the safety and benefits of the products made by them.
The Product Quality Review (PQR – term used by EU GMP) report is a mandatory report which must be prepared periodically to review the quality controls and standards of manufactured drug product. Pharma Companies have to create and submit this report for internal evaluations or keep it ready for inspection. This report creation is a tedious and labor intensive job considering that most of the work is done manually. This involves data to be pulled from multiple sources, analyzed using multiple techniques by various users/parties and consolidate everything in one final report.
Now wait a minute, am I saying that this process is still handled manually? Sounds strange but mostly so, it still is! Why not do away with this manual approach of PQR Report creation and try automating it? Some of the Pharma companies have quality personnel who spend more than half of their time to do data consolidation and get the report ready. While most of their time could be prudently employed on improving the quality processes if the report generation, review and approval was automated or at least semi-automated.
This article outlines a very simple seven steps approach which you can follow to build an automated PQR Solution.
1. Define Solution Requirements
PQR is a data-driven report, created to monitor and review periodical evaluations of quality process and standards of all licensed medicinal products (both starting materials and finished products). So it is of prime importance that data requirements of the Solution should be identified and defined well. Define extra measures to maintain the data integrity especially while performing the multiple data consolidation and transformation operations.
The prime objective of PQR report creation is to meet the regulatory and compliance mandates. To ensure that final report meeting all these mandates, you should explicitly define the regulatory requirements of the solution. These requirements must be in accordance to the FDA/EU GMP guidelines and standards (Refer. EU GMP Guide Part I, Chapter 1.10 and FDA Guideline 21 CFR Part-11). You should also precisely define the requirements corresponding to the e-records, electronic signatures and software or IT systems.
2. Define Universal Report Template
A PQR report consists of multiple sections, sub-sections, tables, analytical charts, diagrams and images. So, in order to handle that define an Universal Report Template which consists of all the possible types of these components that are required to create a PQR report. The Universal Report Template should be considered as base for creating specific templates to address different product types or organization specific requirements. The template used for preparing a PQR report must ensure that it is aligned well with the regulatory and compliance guidelines.
3. Define Core Business Process
The Core business process is the heart of the solution. Big Pharma companies have manufacturing units spread across several countries and sites, involving multiple stakeholders of various organizational divisions. In these kind of scenarios it becomes even more important to define a core business process which is mutually agreed by all the different stakeholders involved. To accomplish that, create a business process (global in nature) by streamlining the various country/site specific processes.
An ideal process should be generic enough to accommodate all the different local scenarios and also be able to handle multiple organizational specific variants. The Business process to create and manage PQR reports includes the following process components:
- Review and Approval
4. Define Business Rules and Exceptions
The most important part of the solution is to identify and define the multiple business rules which will holds the business logic to automatically transform the data according to their respective placeholders. Business rules and defined core business process constitute the automation engine of the solution.
Exceptions enable you to handle and manage any unanticipated scenarios. This will provide robustness to your solution.
5. Build Prototype and Simulate Business Scenarios
After defining the solution requirements, the report templates and the core business process it will be wise to validate your solution approach. Validation can be easily done by creating a quick prototypes, showcasing the mission critical features. Multiple business scenarios should be validated and confirmed using process simulations. This activity will help you to identify gaps, challenges, bottlenecks or any redundancies in the solution. The solution prototype and the simulated business scenarios will be also be helpful to get the management buy-in for the execution.
This activity also ensures that all required aspects can be evaluated against the multiple regulatory and compliance guidelines and requirements.
6. Build Solution
Once the business solution has been conceptualized with the help of prototypes and business scenario simulations the automated solution can be built in straight forward way. Any business process management based technology which enables to implement the designed business processes will be ideal for building such solutions easy and fast. By using Business Process Management Suites (BPMS) you can execute and automate the multiple activities defined in your business processes. You can also harness the social and collaboration features of BPMS which can be very useful when multiple users collaborate to prepare and consolidate results to finalize the report.
7. Monitor and Optimize the Solution
The final PQR automated solution should be used as an effective product quality improvement tool. For this the solution should be continuously tracked and monitored to identify the opportunities of further optimization and enhancements. Key Process Indicators (KPIs) identified during the solution conceptualization phase must be watched regularly to find any issues or bottlenecks. Well-defined basic level of reports in the solution can proof very helpful in this context. These reports will helps to identify the multiple-improvements which could at some point be implemented in the system to reduce the operational-cost and to increase the overall performance.
An effective and efficient business process is the key to build a robust automated PQR Solution.
The automated solution will helps you to eliminate errors in the report and thus will increase the overall effectiveness of the process. It will be a big boost to productivity of all the responsible users, as the system will be doing most of the data consolidation and analysis automatically leveraging smart business in the process.
A well-developed automated solution will enable your team to efficiently produce standardized and consistent reports meeting regulatory mandates. This helps you to avoid any unprecedented compliance challenges or any regulatory scrutiny. This will give your team an extra edge over your competition.
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