Recent Projects | Quality Assurance
- A "virtual" company received a GMP deficiency letter following a UK MHRA inspection because they were not adequately assuring the quality of sub-contractors' work. We supplied an experienced quality assurance professional who worked for the client for three days each month and ensured that all work was carried out according to GMP and project requirements.
- We recently carried out pre-audits of several manufacturing plants in India prior to full MHRA audits. We were able to advise on several changes to conform to regulatory requirements and GMP, and the subsequent MHRA inspections were successful.
- We carry out Qualified Person release of marketed products and clinical trial supplies for a number of clients.
- A client was experiencing a series of batch rejections due to poor content uniformity. We conducted an in-depth analysis, identified the cause of the problem, recommended process improvements to resolve the problem, and carried out validation studies to meet regulatory requirements.
- We have set up GMP-compliant Quality Assurance systems for our clients, including writing Standard Operating Procedures and training staff in the new system.
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