SeerPharma is assisting a number of start-up biotech companies with implementing a basic Quality Assurance Plan (QAP) – a building block of a fully-fledged Quality Management System. The QAP can be put in place to grow as companies mature.
The QAP is an interactive roadmap designed to step people through the legal and good practice arrangements surrounding setting-up and managing pre-clinical and clinical trial operations. It distinguishes between legal and good practice requirements, and provides an overview of each step, along with links to more detailed information where appropriate. It indicates which steps are governed by company policies or standard operating procedures and which are subject to project controls (science- and risk-based).
SeerPharma’s Quality Assurance Plan includes the following elements:- Roles and Responsibilities
- Process Map
- An understanding of where the QAP fits within a Quality Management System and the applicable Regulatory Framework
- A “roadmap” for achieving compliance (performance standards and record keeping requirements)
- A list of references
- A list of SOPs needed to implement and maintain the QAP
SeerPharma’s Quality Assurance Plan has proven popular with many start-up companies in the Asia-Pacific region who are leaning on our expertise in understanding how their organisation will be scrutinised by regulators such as the FDA and TGA.
Contact us should you wish to learn more about our Quality Assurance Plan and how it may assist your organisation.
This post comes from our October 2016 Journal. You may also be interested in:
- QMS Help for Biotech and Medtech Start-ups
- Data Security Support for Small Biotech Company
- Developing a Supplier QA Program for Pharmaceutical and Medical Device Companies
