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 written, 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) ensure product quality is maintained 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 Group'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 validation, 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 risk impacts that affect testing. Determine the risk profile of 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.
GxP Systems Compliance and Validation
What is GxP Systems Compliance and Validation?
GxP systems compliance is adhering to regulatory guidelines and requirements for industries such as the life sciences. GxP incorporates regulations and standards followed by biotechnology, pharmaceuticals, healthcare, and medical devices. GxP systems validation ensures that life science companies maintain high standards in the quality, efficacy, and safety of their processes, products, and documentation. Implementing standardized procedures affecting product lifecycle is essential in GxP systems compliance. Failure to commit to GxP system validation can result in penalties, recalls, damaged reputation, and possible legal drawbacks.
Why is GxP Systems Compliance and Validation Important?
GxP systems validation is fundamental to ensure regulatory compliance, demonstrating that systems consistently meet requirements and ensure compliance with regulatory standards. GxP computer system validation ensures that testing, manufacturing, and distribution processes reliably perform as intended. The GxP systems validation process involves identifying and addressing risks associated with critical functions, equipment, and systems to ensure the quality and safety of products.
A commitment to compliance minimizes failures and deviations that can cause quality issues, product recalls, or consumer harm. Software validation can optimize processes by identifying inefficiencies so that standardized procedures enhance productivity, reduce waste, and minimize errors. Organizations implementing improved controls manage risks and establish appropriate monitoring, verification, and validation mechanisms to ensure ongoing compliance.
Validated systems and processes demonstrate a proactive approach to quality management and compliance, enhancing an organization’s preparation for regulatory inspections and audits. Compliance with GxP regulations helps instill confidence in customers, partners, and stakeholders. It demonstrates a commitment to safety, quality, and regulatory compliance and creates a reputable presence in the life sciences.
What are Common GxP Regulations and Guidelines?
Good Manufacturing Practice (GMP)
Guidelines that cover quality control, manufacturing, documentation, and personnel training to ensure the consistency and quality of pharmaceuticals, food products, and medical devices.
Good Laboratory Practice (GLP)
Guidelines on the quality and integrity of non-clinical laboratory studies conducted to support regulatory submissions.
Good Clinical Practice (GCP)
Guidelines for designing, conducting, and reporting clinical trials involving human participants to ensure the safety, rights, and well-being of trial subjects and the reliability of trial data.
Good Pharmacovigilance Practice (GVP)
Guidelines for detecting, assessing, and preventing adverse effects or other drug-related issues for monitoring medicinal products and reporting adverse outcomes.
Good Distribution Practice (GDP)
Guidelines ensure the adequate storage, transportation, and distribution of medicinal products that include temperature control, product tracking, documentation, and quality management.
Good Documentation Practice (GDocP)
Guidelines for the creation and maintenance of documentation in a regulated environment that includes principles for documentation preparation, revision, approval, and storage.
Good Data Management Practice (GDMP)
Guidelines for the proper data integrity and management in regulated industries like the life sciences that cover data collection, recording, retrieval, storage, and protection.
Good Automated Manufacturing Practice (GAMP)
Guidelines for validating and controlling automated systems used in medical device and pharmaceutical manufacturing to ensure the reliability and integrity of computerized systems.
What is Involved in GxP Systems Validation and Compliance?
GxP systems validation process ensures that design and implementation are consistent and efficient and involves documentation to demonstrate that the system performs as intended, meets user requirements, and produces accurate results.
Standard Operating Procedures (SOPs)
Instructions that outline steps and protocols for various activities within the GxP system, like data management, change control, and quality assurance. GxP compliance involves developing and implementing robust SOPs and ensuring personnel completes training.
GxP systems require a change control process to manage modifications or system updates to properly evaluate, document, approve, and implement changes while considering their impact on quality, compliance, and safety.
GxP compliance relies on accurate and controlled documentation with established procedures for document creation, revision, review, approval, distribution, and archiving. Protocols and reports are maintained in a controlled and consistent manner.
Personnel involved with GxP systems must receive adequate training on relevant regulations, procedures, guidelines, and practices. Training records demonstrate personnel experience and compliance with training requirements.
GxP systems benefit from a risk assessment to identify potential vulnerabilities associated with system processes. Risk management strategies like risk mitigation address identified risks and ensure compliance.
Inspections to assess compliance with GxP regulations and guidelines involve facilitating audits, addressing findings, and implementing corrections and preventative actions.
Compliance includes implementing controls that prevent data manipulation and unauthorized access while establishing data backup and recovery procedures. Data must be protected to maintain accuracy, consistency, and reliability.
GxP systems require a robust quality management system (QMS) that includes processes for quality planning, quality control, quality assurance, and continuous improvements. GxP compliance involves periodic quality reviews.
Supplier and Vendor Management
GxP compliance extends to suppliers and vendors who provide materials and services. Compliance involves assessing quality suppliers, establishing supplier agreements, and monitoring their performance to ensure the quality and reliability of products and services provided.
Who is responsible for GxP systems compliance?
GxP computer system validation is a shared responsibility amongst stakeholders within life sciences organizations. Management is accountable for setting the compliance strategy, issuing resources, establishing procedures, and advocating for a culture of compliance. The Quality Assurance (QA) department ensures that systems and processes meet regulatory requirements and quality standards. QA personnel are involved in computer system validation, document control, training, audits, and inspections.
The Information Technology (IT) department is accountable for implementing, maintaining, and supporting GxP systems. IT collaboration with other departments ensures that systems are effectively deployed, adequately validated, properly maintained, and compliant with cybersecurity requirements. Regulatory Affairs understands and interprets relevant guidelines and regulations to ensure GxP systems comply with regulatory requirements.
Operational teams like manufacturing, laboratory, distribution, or clinical execute GxP processes and ensure systems are correctly used, data is accurately captured, and processes follow applicable regulations and guidelines. Training and Human Resources guide personnel on GxP regulations, procedures, and the organization’s policies with training programs and records.
Compliance and legal departments guide organizations in compliance by monitoring regulation changes, assessing compliance status, and advising risk management strategies. Suppliers and vendors provide critical materials, components, and services that must meet the organization’s quality standards and relevant regulations while providing necessary documentation.
What are Common Challenges in GxP systems Compliance?
GxP system challenges can arise from an evolving regulatory landscape and technological advancements. Understanding and translating changing regulatory requirements can be challenging without the help of regulatory experts interpreting and applying regulations correctly.
Validating GxP systems is time-consuming and resource-intensive to ensure the system is compliant in design, implementation, and operation. Moreover, system upgrades or changes can pose the additional challenge of maintaining a validated system state. Upgrading or replacing legacy systems and infrastructure to meet GxP requirements can be challenging if an organization lacks documentation, validation, and data integrity controls.
Data integrity maintenance is essential but challenging throughout the GxP systems lifecycle. Data must be complete, reliable, and secured from unauthorized access or manipulation with robust controls, data backup, audit trails, access controls, and cybersecurity measures.
Implementing changes to GxP systems while maintaining regulatory compliance is a challenge if there are no proper change control processes, impact assessments, risk evaluations, and documentation to manage changes effectively and not compromise the validated state or introduce compliance risks.
Preparing for and managing audits is challenging to manage timelines and resource requirements. Organizations must have comprehensive training programs and ongoing training to keep up with changing regulations and technologies.
Establishing a culture of compliance in an organization requires consistent communication, training, reinforcement of compliance expectations, and a proactive approach to addressing compliance issues.
What are Common Best Practices for GxP systems Compliance?
- To ensure effective GxP system validation, an organization must establish a compliance framework that includes procedures, policies, and guidelines specific to GxP validated systems. Roles, responsibilities, and communication channels must be clearly defined for compliance activities.
- Staying informed on the latest GxP regulations, guidelines, and industry best practices helps establish processes for monitoring regulatory changes and ensures timely implementation of necessary updates to maintain compliance.
- Adopting a risk-based approach prioritizes compliance to identify and assess risks associated with GxP processes, focusing on areas with high potential impact on product quality, patient safety, and regulatory compliance.
- GxP systems validated appropriately demonstrate they operate as intended and meet regulatory requirements. Maintaining validation documentation, conducting periodic reviews, and addressing deviations promptly are essential GxP best practices.
- Establishing a robust document control system to manage GxP documentation implements procedures for document creation, revision, review, approval, distribution, and archiving. Documents need to be easily accessible, controlled, and updated as required.
- Ensuring employees are trained in relevant regulations, procedures, and practices by maintaining training records and a consistent culture of compliance to keep up with evolving requirements.
- Implementing robust data integrity controls ensures the accuracy, completeness, and reliability of data generated by GxP systems with audit trails, data backup, access controls, and periodic data integrity reviews.
- Conducting periodic management reviews to assess GxP validated systems provides oversight and ensures accountability for compliance activities.
- Fostering a culture of continuous improvement identifies opportunities for enhancing compliance and monitors key performance metrics to track compliance effectiveness.
Compliance of GxP Systems with Arbour Group
Arbour Group has the proven regulatory expertise to benefit a Life Sciences 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 Group’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.