Symphony focuses on quality by design and we continue to leverage our innovation-centric strategy to achieve operational excellence. We have implemented a robust Quality Management System (QMS) that establishes quality standards and methods. Our QMS adopts a compliance approach, which encompasses the entire product lifecycle, from development to commercialization. The QMS is updated regularly based on new regulations and evolving compliance requirements to guarantee that operations comply with Current Good Manufacturing Practices (cGMP) criteria across the globe.
We consistently collect regulatory intelligence to evaluate new recommendations issued by various regulatory organizations which propels our efforts to integrate industry best practices and enhancement of our business processes.
At Symphony Formulations We Follow
Establishing a Robust QMS Framework
Foundation in ICH Q10: We use the ICH Q10 guideline as the backbone for an effective pharmaceutical quality system.
Policy and Objectives: predefine clear quality policies aligned with regulatory expectations and company goals.
Integrated Approach: Quality processes are ensured and embedded across formulation, analytical development, process development, and tech transfer.
Quality Risk Management (QRM)
Risk-Based Decision Making: We use tools like FMEA, Ishikawa diagrams, and risk matrices to evaluate and control risks.
Proactive Controls: Anticipate potential failures in development processes and address them early.
Risk Reviews: Regularly review and update risk assessments as more data becomes available during development.
Change Management
Structured Change Control System: Evaluation, documentation, and approval of any changes in process, equipment, or materials.
Impact Assessment: Analyse potential impact of changes on quality, safety, and regulatory compliance.
CAPA Management
Corrective and Preventive Actions (CAPA): Implementation of CAPAs with clear timelines, responsibilities, and follow-up.
Effectiveness Checks: Verification of CAPAs through audits or trend analyses if CAPAs are working properly or not.
Training and Competency
Training Programs: Regular, role-specific training on GxP, quality principles, and regulatory updates.
Competency Evaluation: Assess effectiveness of training through tests, audits, or performance reviews.
Culture of Quality: Promote ownership of quality across all levels of R&D personnel.