Bioassay is dedicated to providing high quality services to our clients underpinned by robust quality management system. We have established a robust quality system that governs every aspect of our operations. Our quality system is designed to meet regulatory requirements, maintain data integrity, and continuously improve our processes to deliver exceptional service and testing results.
We strive to deliver precise and dependable potency and efficacy testing services while maintining a culture of quality throughout our organization.
Key Components of Our Quality System:
1. Regulatory Compliance: We adhere to applicable regulatory guidelines for the service you are performing with us. Our quality system supports our compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), FDA and other relevant industry-specific guidelines.
2. Documentation and Record Keeping: We maintain comprehensive and accurate documentation. This includes protocols, standard operating procedures (SOPs), batch records, test reports, and other relevant documentation. We employ a robust document control system to ensure integrity, accessibility and traceability.
3. Qualified Personnel: Our team consists of highly trained and qualified professionals who possess the necessary expertise and experience to perform the services. We invest in continuous training and development programs to keep our personnel updated with the latest industry practices.
4. Equipment and Facilities: Our equipment undergoes regular calibration, maintenance, and qualification procedures to ensure accuracy, reliability, and traceability of results. Our testing facilities adhere to appropriate safety and security measures.
5. Quality Control and Assurance: We have implemented a robust quality control program throughout the testing process. This includes the use of appropriate reference standards, internal quality control samples as well as conducting internal audits.
6. Continuous Improvement: Part of our quality system includes a committed to continuous improvement. We monitor and evaluate our processes to identify opportunities for enhancement. Feedback from clients, regulatory authorities, and internal assessments are key inputs for implementing improvements to our quality system.
Our quality system was established to ensure we meet regulatory requirements and client expectations enabling us to contribute to the advancement of new drugs to the clinic.