MSAT support
GMP Regulations
Our experts provide MSAT support to navigate the complex landscape of regulatory requirements for the manufacturing of biopharmaceutical products. We provide guidance on current Good Manufacturing Practices (cGMP) and compliance audits, ensuring clients adhere to strict cGMP standards. Furthermore, we support validation activities, including equipment qualification, process validation and analytical method validation, to ensure regulatory compliance and product quality throughout the life cycle.
Troubleshooting, Deviations and CAPA’s
Despite careful planning, unexpected manufacturing challenges can arise. Progress experts excel at troubleshooting issues related to process deviations, product quality discrepancies and equipment failures. By conducting thorough root cause analyzes using tools such as failure mode and effects analysis (FMEA) as outlined in ICH guideline Q9 (R1) on quality risk management and statistical process control (SPC), our experts identify underlying problems and effectively implement corrective and preventive actions (CAPAs). This initiative-taking approach not only resolves immediate issues, but also prevents them from recurring, ensuring product quality and patient safety.
Continuous Improvement and Change Control Management
At Progress, we foster a culture of continuous improvement, supporting clients with life cycle management activities such as process development and optimization, process revalidation, technology upgrades and post-market process changes. Process improvements will be initiated in accordance with applicable Change Control procedures. To provide effective MSAT support, our consultants are up to date with the latest developments in technology and regulatory requirements, and together with our clients we adapt to the evolving industry trends and maintain a competitive advantage in the market.
Through our collective specialized knowledge, collaborative approach, and commitment to continuous improvement, we enable clients to optimize processes and ensure regulatory and cGMP compliance throughout the product life cycle. To the top, together!
Technology Transfer, Scale-up and Validation
We provide support for technology transfer between different manufacturing sites or from development to commercial production. We ensure smooth process transitions by conducting thorough process evaluations, risk assessments and validation studies. Additionally, we support scale-up activities to ensure that processes remain robust and consistent on a larger scale, minimizing the risks associated with process variability and ensuring product quality and consistency.
In short, Progress is your partner for optimal MSAT support.
