Home » Validation in Pharmaceutical Packaging IQ/OQ/DQ, FDS/HDS/SDS
Validation
In Universal Pack validation encompasses various aspects aimed at mitigating risks and guaranteeing optimal operational quality and safety.
Validation plays a crucial role in ensuring the safety, efficacy, and integrity of products as well as guaranteeing that processes consistently meet predetermined standards. In Universal Pack validation encompasses various aspects, including equipment performance, working values, safe parameters, process control, data integrity, all aimed at mitigating risks, and guaranteeing optimal operational quality and safety.
As a leading provider of packaging solutions for the pharmaceutical sector, we have designed our machines with the utmost dedication to validation principles. Our validation procedures encompass the following key elements:
Design Qualification (DQ):
Before a packaging machine is even built, thorough design qualification takes place. We ensure that all aspects of the machine’s design meet the industry’s stringent regulatory requirements. This includes considerations such as material compatibility, hygienic design, and adherence to Good Manufacturing Practices (GMP) guidelines.
Installation Qualification (IQ):
During the installation phase, our experienced team verifies and documents that the packaging machine is installed correctly, in accordance with the intended specifications and environmental conditions. This step guarantees that the machine is in optimal condition for subsequent validation activities.
Operational Qualification (OQ):
In the operational qualification phase, we thoroughly test and document the performance of the packaging machine. This involves verifying critical parameters such as temperature control, sealing integrity, dosing accuracy, and overall functionality. Our single-dose packaging machines and lines are designed to accommodate a wide range of packaging formats, ensuring versatility and adaptability for various pharmaceutical products.
Performance Qualification (PQ):
The performance qualification stage evaluates the packaging machine’s ability to consistently produce the desired results under normal operating conditions. We conduct extensive testing, monitoring critical process parameters, and assessing product quality. This is to make sure that our machines meet the stringent requirements for pharmaceutical packaging, such as maintaining proper sealing, avoiding contamination, and enabling accurate labeling as well as tracing the final product.
What specific documents can you provide?
FDS (Functional Design Specifics) is a document that explains how the machine design will meet customer requirements, serving as a foundation for system design. It ensures that all requested functions are present and operate correctly, and also aids in system verification and validation during testing.
HDS (Hardware Design Specifics) is a document that provides an overall description of the hardware and its implementation. It includes details about the main components, iterations, and requirements for connecting to utilities and installation.
SDS (Software Design Specifics) is a document that offers a general description of the software, its functions, and the human-machine interface. It outlines the software’s role and features within the overall system design.
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TECHNICAL
Technical cookies are needed to make the website usable, enabling basic functionality such as the navigation on the pages and the use of existing services. Moreover, they allow to gather anonymous statistics about the navigation. The website can not work correctly without these cookies.
PREFERECES
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ANALYTICAL
Analytical cookies are used to process aggregate statistical analysis about the use and interaction by the user with the website.
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Profiling cookies allow to gather information about expressed preferences by the user during its navigation and to process reports intended to be used for targeted marketing and advertising campaigns.
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