Flamma has over 100 audits each year. By going above and beyond the quality requirements, we strive to continually become a better partner.
Flamma is using Pharmaceutical Quality by Design (QbD). QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. QbD is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance.
Flamma uses an enhanced QbD approach to pharmaceutical development and thus provides opportunities for more flexible regulatory approaches.
Flamma delivers QbD to its customers to give them the following benefits:
- Improved understanding of the manufacturing process
- Less batch failures
- More efficient and effective change controls
- Providing an enhanced cost savings & Return on Investment (RoI)
Manufacturing changes within the approved design space without further regulatory review.
- Time to market reductions: from 12 to 6 years realized by amongst others
- Reduction of post-approval submissions
- Better innovation due to the ability to improve processes without re-submission to the FDA when remaining in the Design Space
- More efficient technology transfer to manufacturing
- Greater regulator confidence of robust products
- Risk-based approach and identification
- Innovative process validation approaches
- Less intense regulatory oversight and less post-approval submissions
- Improved yields, lower cost, less investigations, reduced testing, etc.
- First time right: lean assets management
- Continuous improvement over the total product life cycle
- Realistic risk perceptions