The medical devices industry is considered highly regulated hence device manufacturers must adhere to a strict set of practices, known as, GxP or Good Practices (GMP - Good Manufacturing Practice, GDP - Good Distribution Practice, GLP - Good Laboratory Practice, GCP - Good Clinical Practice and many more).
GxP refers to good practice quality guidelines and specifications, which help to consistently manufacture, store and distribute high-quality products, minimize risks and ensure end-user’s health and safety. Violating these practices will lead to audit observations, product recalls, revenue loss, government fines and expensive lawsuits. In such a scenario, what kind of Regulatory fundamentals one must be aware of for medical devices GxP compliance.
GxP Regulatory Fundamentals: To ensure a device’s safety and security, right from testing to manufacturing and distribution, irrespective of the space in which GxP is used, all the GxP systems revolve around certain aspects which are considered as Regulatory pillars. They are:
Accountability: This is an important pillar of good practice and it refers to the creation and maintenance of all the records and documents, that identify and verify the individuals, who participated in the process of creating a product. Every individual’s qualification, certifications and levels of training are observed, evaluated and documented throughout the device’s lifecycle.
Traceability: It is the ability to reconstruct the development history of a medical device. During the device development, every step in the manufacturing process is noted, any extra developmental process is detailed, the potential deviations from an established process are recorded and the supply chain of every device is traced until it reaches the final outcome.
Data Integrity: It underlies both accountability and traceability and refers to the completeness, consistency and accuracy of data, according to the FDA. The data collection must follow the ALCOA protocol, where the data must be attributable, legible, contemporaneously recorded, original and accurate.
The 5 Ps of GxP: To implement the accountability and traceability standards, a useful framework known as, 5 Ps of GxP is required. It refers to, people (should have clear roles and responsibilities, follow all procedures and be trained and assessed for the works they do), procedures (should be documented and recorded, all critical processes should be covered and all non-conformities should be investigated and reported), products (the raw materials, components, the intermediate and finished product should have specifications on manufacture and packing, research and development, testing, sampling, status control, stability testing and records), premises and equipment (should be validated and calibrated for expected performance, designed for effective cleaning and to prevent cross-contamination and have associated procedures, schedules and records) and processes (all critical steps should be identified, all processes should be defined, consistent and documented and the robust change controls should be in place).
Quality Systems: A Quality Management System (QMS) is needed to define, document, validate and implement all the important GxP processes, which are used to achieve a quality and compliant end-product. Organizations cannot ensure consistency in their processes and procedures without implementing a QMS and can neither rectify the source of non-conformities in the end-product, when identified. The right QMS for any organization must operate as a central repository of best practices and help to control, assemble and track all the documentation one needs to prove GxPs. It entails, setting up document workflows to meet Regulatory requirements and documenting key communication in the product’s lifecycle to prove GxP implementation. The right QMS should help you:
- Maintain knowledge of GxP in your organization
- Achieve accountability for regulated activity
- Use GxP to create high performing products of consistent quality in the most efficient way
- Minimize risk of product failure - proportional to its potential to harm
- Provide evidence that the regulated products are in conformity with Regulatory requirements
Finally, understanding and following GxP is an effective way to ensure the production of safe and compliant end-products. As going through many country-specific guidelines globally would be a huge task, approaching a proven local Regulatory expert can be beneficial. Stay informed. Stay compliant.