Development of QA Systems
Quality Management Systems (QMS) form the backbone of any commercial pharmaceutical or healthcare product. QMS comprises Quality Assurance (QA) and Quality Control (QC), working together to enable the testing, release and sale of a commercial product.
Regulatory Agencies require a full GMP Compliant system to be in place by the time Phase III Clinical Trials are conducted. Quality Systems are developed in phases throughout the pharmaceutical and clinical development process, during the early stages both the process and product are anticipated to rapidly change. Phase I Clinical Trials see fewer changes; however, the process and the product will not be completely defined even at this stage and so only a small percentage of the overall Quality System is required. For phase II Clinical Trials expectations grow and for Phase III a full Quality System should be in place prior to submission and approval.
The Quality Assurance department has oversight and responsibility for all control points during the manufacturing of a product throughout the pre-clinical, clinical trials, and commercial stages. QA writes detailed procedures for all of the company’s operations, ensures compliance with regulations and internal written procedures, and is responsible for developing and tracking all documents within the Quality System, including:
• Standard Operating Procedures (SOPs)
• Official forms, Technical Reports
• Validation Plans, Protocols and Reports
• Batch Manufacturing Records (BMRs)
• OOS, Deviations and Discrepancies
Quality Control is responsible for managing and implementing the company’s core Quality Systems and ensuring compliance to cGMP and ICH standards. QC has the “final word” on the release of raw materials, intermediates and final product, their responsibilities include maintaining adherence with a range of processes and departments, including;
• Change Control
• Deviations and OOS Investigations
• Clinical Trials
• Technology Transfer
• Raw materials
• Product Release
• Customer Complaints
How Woodley BioReg can help with Quality Systems
Woodley BioReg provides QS support in several ways. We can help in the development of new systems as well as provide evaluation of existing systems, your stage of development, and the resources available in order to make the most appropriate recommendations. Woodley BioReg also helps clients develop a time-line, including an overall Validation Master Plan and determine the level (if any) of external support and assistance required to develop and implement a full Quality System.
For more information on Quality Systems please contact us.