The Importance of GxP and GMP
Let’s dive into the foundational principles of Good Process Design Practice (GPDP), derived from the principles of GxP and Good Manufacturing Practices (GMP) – a crucial standard within various industries. Understanding GMP is essential for professionals involved in the production, quality control, and distribution of products for Pharmaceuticals, food, cosmetics, etc. Understanding GPDP on the other hand, is essential for professionals involved in process design.
GxP
GxP, shorthand for “good practice,” encompasses guidelines and regulations crucial for ensuring the safety, effectiveness, and usability of products in industries such as food, medical devices, and pharmaceuticals. It encompasses various disciplines like Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Laboratory Practice (GLP), among others. These standards set by regulatory bodies like the FDA, EMA, MHRA, and ISO are pivotal in controlling processes, procedures, personnel, and premises to maintain consistency and quality in products.
GMP
GMP refers to a system of guidelines that ensure products are consistently produced and controlled according to quality standards. It’s designed to minimize risks involved in manufacturing processes that can’t be eliminated only through final product testing. Its main goals are to protect the consumer from purchasing a product that is not effective or even dangerous.
What is Good Process Design Practice (GPDP)?
Safety
AseptSoft prevents the engineers from drifting the project into a bag of improvisations. AseptSoft introduces a further developed GxP principle, which ensures compliance with standards. It calculates the path of the fluids through the pipes and recalculates automatically upon valve changes, preventing errors in the process.
Quality
AseptSoft guarantees high-quality standard workflow, “carved in stone” according to your settings. With AseptSoft, you can count on the same quality of your Process Design from project to project, without any effort. It ensures that changes in parameters, variables, dialogs, or instruments are consistently reflected throughout the project, preventing inconsistencies.
Risk Reduction
AseptSoft protects the project from losing consistency by automatically adapting documentation and recalculating fluid paths. The standardized approach prevents mistake and deviations, reducing the time-consuming correction process.
Recognition
AseptSoft keeps your project within the good practice range. Through the further developed GxP principle, enhancing the recognition of your project’s adherence to Process Design standards.
A few examples when AseptSoft comes in handy to protect the project from losing consistency
- AseptSoft calculates the path of the fluids that run through the pipes. This is calculated/recalculated automatically upon valve opening/closing, so there is no way the operator can draw a wrong path.
- When the operator changes the state of a valve in the design phase, AseptSoft automatically adapts the entire documentation to include the new change.
- When the operator renames a Parameter, a Variable, a Dialog or an Instrument, AseptSoft replaces the old name with this new name in all the conditions of the Algorithm, to ensure that there are no inconsistencies.
A few examples when AseptSoft keeps the documentation clear and ensures there are no forgotten parts or mistakes
- You can navigate through all the steps of the processes and validate (confirm that it is the correct design) the state of each item (valves, pumps, heat exchangers, etc). This validation automatically shows “complete” when all the processes have been fully validated. It automatically becomes “outdated” when some valves changed, thus lost their validations. That way, it ensures no changes can pass unnoticed and every valve open/close change requires the supervisors of the team to confirm that change. Only then the “outdated” situation will turn back into “completed”.
- Upon any change like valve colour change, introduced new process step, new dialog or new transition between steps, AseptSoft updates the entire documentation. The updated documentation can be within the excel files with information about the valves colouring, or even the PDF with the valves in each step.