GMP is a regulatory tool that aims to verify if products are consistently produced according to quality standards, and if they are appropriate for their specific use or specifications.
These regulations demand a quality approach in which all operations and people must be envolved. In fact, reguloratory entities execute this process ponctually. For this reason, companies must engage into continuous verifications to minimize or eliminate instances of contamination, mixups and errors, avoiding that consumers purchase something bad or dangerous.
GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
The process is divided into 4 major steps:
Walkthrough the factory to observe activities, processes and products.
Secondly, all processes associated documents are reviewed to ensure if the followed processes are in conformity.
Finally, a GMP audit checklist is prepared for specific verifications og both of the above activities.
Results are analysed.
The process requires steps that take into consideration 5 fundamentals: Risk Management, Quality Management Systems, Facilities Management, Product Contol and, finally, Continuous Improvement of all actions.
Through process digitalization, GMP Audit checklists can be created digitally, reducing paper use. These lists are organized according to different workflows and inputs, and displayed in workers mobile devices or HoloLens to guide them through their verification tasks.
Workers can be guided in real-time with the support of Augmented Reality (AR). This can present a plus regarding the factory walkthrough Audit since it combines both observation and access to documents and processes, simultaneously.
GMP Audits are executed with more and easy access inforamtion, which ensure a more viable analysis of the results. Centralized information, as well as theit real-time access transform spread data into knowledge that can be used into different layers of the factory, facilitating communication. Additionally, audits are less costly and take less time to do due to the fact that checklists are digitized, and AR support is added to guide and facilitate workers daily lives.
With our technology, processes are digitized in order to centralize all information into one platform. Which can be complemented with the integration of different software that are already used in operations, to optimize the core of data extraction, and its value for decision-making. Combined with different inputs from execution, the process information can then be automatically transformed into table reports for analysis. Less communication layers and walls translate into more accurate data regarding safety patterns. Those become easier to confirm, in less time so it can be executed more frequently. Consequently, safety and quality patterns are constantly ensured and improved.