FreeThink Quality Management System

The FreeThink Quality Management System was designed to guide and implement cGMP studies using the most modern quality systems and risk management approaches.  This system also ensures adherence to the requirements of the US FDA’s current Good Manufacturing Practice (cGMP) regulations.  Our comprehensive Quality Management System guarantees high quality and fully-verified data for each cGMP study, to assist you in regulatory filings.  In addition, FreeThink’s experienced staff recognizes the need for any given program to meet global compliance, and is knowledgeable in international regulations and guidelines.  The FreeThink Quality Management System revolves around support and feedback from Analytical Sciences (Quality Control), Quality Assurance, Executive Management and outside stakeholders, which frame our quality processes, standards, and controls.


FreeThink Quality Policy

FreeThink is committed to carrying out its operations with the highest quality standards. Our policies, Standard Operating Procedures (SOPs) and practices have been implemented to form the foundation of our Quality Management System. This includes analytical testing of active pharmaceutical ingredients and pharmaceutical products using cGMP. It also includes our policies, SOPs and practices through to the retention of data, records, and documentation generated.

  • Each scientist at FreeThink is accountable for ensuring that data generated are accurate and reliable, with the work carried out according to approved protocols and SOPs. Nonetheless, scientists are strongly encouraged to raise any concerns with these protocols or SOPs, and to examine data generated to assure quality at all stages. All scientists have appropriate education, training, and experience to carry out the job functions in accordance with applicable FreeThink policies, procedures and regulations. FreeThink management is committed to supporting a quality culture. The management team encourages employees to regularly challenge the status quo, and to constantly improve processes.
  • FreeThink welcomes feedback on our processes from clients who entrust us with their testing needs, as well as from findings resulting from audits and inspections conducted at our facility. Both are considered approaches to strengthen the company’s commitment to quality improvement.
  • All activities conducted on-site shall value, above all else, protecting individuals and the environment.

cGMP Standard Operating Procedures (SOPs)

FreeThink has a comprehensive Quality Management System containing internal cGMP SOPs and working instructions which are continuously monitored, maintained and improved. SOPs are inspected and reviewed routinely for compliance to the set quality standards, and encompass all cGMP operations from receipt of the study sample through to the final report generation. FreeThink SOPs are in a categorized system, and have been developed based on the most current scientific advancements and regulatory expectations.

Fully-Trained cGMP Scientists & Quality Assurance Professionals

FreeThink’s experienced laboratory scientists come to us from cGMP environments at some of the world’s largest and most respected pharmaceutical companies. For every FreeThink study conducted, we staff a team of dedicated, fully-trained, cGMP-qualified researchers. We have a comprehensive system for educating our analysts in cGMP work, and take pride in hands-on training from some of the industry’s leading stability experts. Technical training is completed and documented prior to any cGMP analyses, including training and testing for competency on all cGMP instrumentation. Additional instruction is also provided annually to stay abreast of the latest global regulatory requirements and updates. FreeThink has a stand-alone Quality Assurance team, with a 3-to-1 ratio of laboratory analysts to QA professionals.

 

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