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What are GxP guidelines?
Good Practice (GxP) standards are set by governing agencies like the Food and Drug Administration (FDA) for industries that are heavily regulated. Organizations in the Life Sciences including Biotechnology, Medical Device, Pharmaceutical, and Diagnostics have requirements set to ensure products manufactured are safe and meet strict quality standards throughout the entire process of production.
An organization that is highly regulated must have fully trained staff with clearly defined responsibilities to ensure procedures are followed. The procedures must be clearly defined, well-documented and consistent to cover all critical processes. Premises and equipment should have established measures, schedules, and records while products have specifications for testing, sampling, status control, and records.
Types of GxP
The ‘x’ represents a field of focus for Good Practice compliance standards. Good Manufacturing Practices (GMP) ensure packages and products are labeled correctly, are uncontaminated and meet intended claims. Good Documentation Practices (GDP) maintain product quality throughout all stages of the supply chain. Good Laboratory Practices (GLP) promote the development of quality and reliable test data. Good Clinical Practices (GCP) ensure subject rights are protected and that data is credible in clinical trials.
A documented Quality Management Systems must be put in place for all Life Sciences organizations to ensure reliable processes have been implemented and followed. Whether a company must comply with GCP, GDP, GLP or GMP, Arbour Group’s client-focused approach assists in testing a computerized system for its specific GxP validation specifications. Ensure adequate procedural controls are established and proper system user training is put in place with Arbour’s GxP compliance consultants.
The GxP System Validation Process
The Good Automated Manufacturing Practices (GAMP 5) is an advisory document, published by The International Society of Pharmaceutical Engineering (ISPE), with recommended methodologies for validation of GxP computerized systems. It specifies what deliverables are needed, what should be tested, the number of tests, how tests should be conducted, and how they should be documented. But how does GxP impact the process?
During software testing, functional software system processes that are governed by GxP regulations must be identified. An assessment should be performed to address the probability of risk (probability of occurrence and/or detection) for each GxP functional process (or group of processes) to determine a proper risk priority, which in turn, will define the testing strategy. Arbour Group can assist not only in conducting a Risk Assessment to identify key risk consequences, but also help in mitigating the GxP regulations that affect testing. Determine the prioritization of fixes to a system and when it is acceptable to release a system with support from Arbour Group.
Requirements Traceability Matrix
Test coverage must be documented of all critical GxP requirements. The testing must have traceability between specifications. Arbour group can assist in the execution and managing of all documentation needed to meet necessary good practice standards, including a Requirements Traceability Matrix. Provide FDA GxP compliance and accountability of all testing conducted with the proper documentation.
User Requirements and Functional Specifications
Systems that must adhere to GxP regulations need a set policy in place for defining the testing scope. This scope should be predetermined and documented. Arbour Group can assist by developing or supplementing your documentation with verified User Requirements and Functional Specifications.
Master Validation Plan and Test Protocols
When validating a system to its intended use, it is essential to address how GxP and non-GxP functions will affect the scope and process of testing. A Master Validation Plan determines the testing strategy while a Test Protocol proves the system operates as it should. A protocol must be put in place to explain how the testing will be implemented and should cover the risk priority of GxP affected functions being tested. Arbour Group’s compliance expertise can support in supplying all the necessary documentation to demonstrate a set methodology is in place.
Validation Summary Report
Tests that were executed successfully, along with the disposition of failed tests, must be properly documented to indicate to regulatory agencies that a proper GxP system validation process has taken place. Furthermore, a post-execution review and report of validation are essential GxP compliance requirements. Arbour Group’s Validation Summary Report is a key part of Arbour Group’s GxP software validation package delivered by compliance experts while incorporating industry best practices.
Compliance of GxP Systems with Arbour
Arbour Group has the expertise in training, procedural controls and documentation standards to benefit a Life Sciences regulated organization. GxP systems can be aligned with compliance initiatives to meet both best practice guidelines and validation requirements. Navigate the GAMP 5 recommendations with Arbour’s GxP validation services that are composed of proven test methodologies.
Talk to an Arbour Group specialist to find out how we can assist with your GxP compliance checklist needs.
Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner.
The use of Arbour’s validation product greatly facilitated the process.
The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers.
Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs.
Arbour Group provided effective validation services to us and were a valuable part of the overall success of our company-wide ERP implementation.
Their integration into our multi-phase ERP roll out was seamless and assured us of comprehensive regulatory compliance.