Reagent Manufacturing

Quality Management System (QMS) Implementation

Documented Processes: All processes for enzyme production must be thoroughly documented. This includes production workflows, quality controls, and testing protocols.

Risk Management: A risk-based approach is required to evaluate potential risks in enzyme production, ensuring processes are designed to mitigate risks to product quality and patient safety.

Traceability: Enzyme batches must be fully traceable throughout the production and supply chain. This includes raw materials, production lots, and final product delivery.

Design and Development Controls

Product Design Control: If the enzyme is specifically developed for medical purposes, design controls need to be in place to ensure the product meets regulatory and performance requirements.

Validation and Verification: Processes and methods for enzyme production must be validated to ensure they produce enzymes that meet defined specifications and performance characteristics.

Production Controls

Clean Room and Sterility Requirements: Depending on the intended use of the enzyme (e.g., for sterile medical applications), production may need to occur in controlled environments like clean rooms.

Contamination Control: Systems must be in place to prevent contamination or degradation of enzyme products. This includes equipment maintenance, personnel hygiene, and environmental controls.

Calibration and Equipment Monitoring: All production equipment must be calibrated and monitored to ensure it functions within defined tolerances.

Supplier Management

Vendor Qualification: Suppliers of raw materials (e.g., substrates or cofactors used in enzyme production) must be qualified, and there should be a process for managing supplier performance.

Incoming Material Control: Raw materials must be tested and verified to ensure they meet predefined specifications before being used in enzyme production.

Compliance with Regulatory Requirements

Regulatory Documentation: You must maintain documentation that demonstrates compliance with applicable regulatory requirements, which can vary depending on the country or region where the product is marketed.

Post-Market Surveillance: There may be ongoing requirements for monitoring the enzyme’s performance in the field, especially if it is used in critical diagnostic applications.

Personnel Training

Competency Training: Personnel involved in the production and quality control of enzymes must be adequately trained in ISO 13485:2016 requirements and specific production processes.

Training Records: Records of all training must be kept and maintained to show that employees are competent and qualified for their roles.

Quality Assurance Testing

In-Process and Final Product Testing: Both in-process and final enzyme products need to be tested to verify that they meet required specifications. This could include activity assays, purity analysis, stability testing, and sterility testing, if applicable.

Documentation of Results: All testing results must be documented and included in the batch records for full traceability.

Continuous Improvement

CAPA (Corrective and Preventive Actions): A system for identifying and correcting problems, as well as preventing future issues, must be in place. This is critical for maintaining the quality and reliability of the enzyme products.

Internal Audits: Regular internal audits are conducted to ensure that the quality management system is being followed, and improvements can be made where necessary.

By following ISO 13485:2016, IBEX Pharmaceuticals ensure that their products are consistently manufactured to meet the stringent quality and safety requirements expected in diagnostic device applications.