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Key Components of TriLink's QSR/cGMP Quality System

TriLink operates a quality system that meets ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section 19, APIs for Use in Clinical Trials and ISO 9001 standard, and practices continual improvement. The following highlights key aspects of TriLink’s quality system:

Quality System
In compliance with ICH Q7 and ISO 9001, TriLink operates a detailed quality system. TriLink performs internal audits to identify areas with possible deficiencies, and areas where cGMP processes can be improved. Quality management meets quarterly, with all departments, to review processes and plan for overall system improvements. ISO 9001 requires that all employees are properly trained on standard operating procedures necessary to perform their function. Personnel training is performed and documented by managers or designees for necessary quality and procedural standard operating procedures. TriLink’s quality department currently documents and maintains records in order to track the following requirements:

- Nonconforming products and materials
- Corrective and preventative actions
- Process deviations
- Material and product verification
- Material and product labeling
- Material and product packaging
- Material and product storage and distribution
- Preventative maintenance and calibration of critical equipment and instrumentation
- Training System

TriLink operates under a five year minimum record retention period.

The quality team at TriLink ensures that all processes are documented and controlled properly in compliance with ICH Q7 and ISO 9001. All critical controlled documents are drafted and reviewed by the end user, and subsequently reviewed and approved (with a date and signature) by Quality Assurance. TriLink's critical documents include: batch records, standard operating procedures, manufacturing process instructions and raw material release specifications. Document change control is utilized by TriLink for changes made to existing critical documents. Change control entails department head and Quality Assurance approval, and a thorough review process.

Product and Material Testing
Receipt, identification and traceability of products and materials are documented in compliance with ICH Q7 and ISO 9001. All raw materials are qualified before they are assigned an internal traceable TriLink lot number for use. Every product or job is designated with a unique lot number before the production process is initiated. Batch records are kept for each lot to ensure that every step in the production process is documented and therefore traceable.

Production and Process Controls
Proper production and process controls are employed to ensure that TriLink's products are of the highest quality and compliant with ICH Q7 and ISO 9001. Manufacturing process instructions are used to communicate manufacturing steps to production personnel. These instructions dictate the necessary processes and ensure uniformity of different lots of material. All of the processes associated with production are documented in the form of standard operating procedures. Deviations from the manufacturing process instructions and standard operating procedures are documented and included in the batch record of the product. Furthermore, all equipment deemed critical to the quality of TriLink products undergoes documented annual preventative maintenance. Inspections of TriLink laboratories and processes are performed by executive management regularly to ensure that standards are being adhered to and improved upon when necessary.



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