Process Validation
#MEDISTRI
#MEDISTRI
Medistri continues to be at the forefront of regulatory requirements and quality proficiency.The US FDA and ISO 13485 require device manufacturers to verify that their products meet documented design specifications, which can be accomplished through inspection or post-production testing.
Process Validation is a systematic approach used in manufacturing industries, particularly those under stringent regulatory requirements, to ensure that a process consistently produces a product that meets its predetermined specifications and quality attributes.
Process Validation is important for several reasons:
Quality Assurance: It ensures that the process consistently produces a product that meets its predetermined specifications and quality attributes. This is crucial in industries like pharmaceuticals and medical devices where product quality can have direct impacts on patient safety and health.
Regulatory Compliance: Process Validation is a requirement of Good Manufacturing Practices (GMP) and ISO standards like ISO 13485 for medical devices. Failure to adequately validate processes can lead to regulatory sanctions including fines and product recalls.
Risk Management: By identifying and controlling critical process parameters, Process Validation helps to reduce the risk of process failure and product defects.
Cost Efficiency: A well-validated process is typically more efficient and less prone to errors and rework, which can lead to cost savings.
Customer Confidence: Products produced from validated processes are more likely to meet customer expectations for quality and performance, leading to increased customer confidence and satisfaction.
Process Validation is typically carried out in several stages. The first stage is Process Design, where data from the development phase are gathered and analyzed to define the commercial manufacturing process. This stage also involves the use of Design of Experiments (DOE) and Quality by Design (QBD) approaches to identify potential sources of variation and establish quality benchmarks.
The second stage is Process Qualification, which involves testing the process under operating conditions and limits to ensure it operates as expected. This includes factors such as temperature, pressure, speed, and other operational parameters.
The third stage is Continued Process Verification, which is an ongoing process that ensures the process remains in a state of control during routine production operations. This involves regular monitoring and control of critical process parameters.
In addition to these stages, there is also Process Revalidation, which involves repeating the validation process at regular intervals or when changes are made to the process to ensure it continues to produce consistent results.
At Medistri, the following standards and guidelines are related to Process Validation:
ISO 13485: This is an international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
FDA Guidance: The FDA provides guidance on the general principles and approaches that it considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances).
These standards and guidelines provide a framework for carrying out Process Validation, ensuring that a process consistently produces a product meeting its predetermined specifications and quality attributes. It’s important to note that the specific requirements may vary depending on the regulatory jurisdiction and the specific nature of the product being manufactured.
At Medistri, the key to perform Process Validation is thorough planning, careful execution of the validation plan, and meticulous documentation of the validation process and results. It’s not just a one-time event but a lifecycle that begins with the design of the process and continues through its entire life span.
🎯 To learn more about Medistri’s Process Validation, visit on our website here or directly contact our team at contact@medistri.swiss.
- The Medistri Team
#Medistri
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