A robust Quality Management System (QMS) forms the foundation of GMP compliance and sustainable pharmaceutical manufacturing. We design, implement and optimize practical QMS frameworks that integrate documentation, risk management, investigations, training, validation and continuous improvement to meet global regulatory expectations.
What We Deliver
- Documentation Management System — Development of document hierarchy, document control procedures, version management and archival systems.
- Internal Audit Program — Development of self-inspection procedures, audit schedules, checklists and audit reporting systems.
- Supplier Qualification — Establishing supplier approval, evaluation and periodic review procedures.
- Complaint & Recall System — Design and implementation of complaint handling, product recall and market complaint investigation procedures.
- Product Quality Review (PQR/APQR) — Development of Annual Product Quality Review systems and trending methodologies.
- Management Review System — Implementation of periodic quality review meetings, KPIs and quality metrics.
- Data Integrity & Good Documentation Practices (GDP) — Implementation of ALCOA+ principles, data governance and documentation best practices.
Our Approach
Gap Assessment
Evaluate existing quality systems against WHO-GMP, revised Schedule M and applicable international standards.
QMS Design
Develop SOPs, quality procedures, documentation structures and quality policies tailored to your operations.
Implementation & Training
Roll out QMS processes, conduct personnel training and establish effective quality practices across departments.
Monitoring & Continuous Improvement
Perform internal audits, review quality metrics, manage CAPAs and continuously improve the QMS.
Who this is for
Why Choose Vaayath
- 20+ years of pharmaceutical regulatory experience
- Expertise in WHO-GMP, revised Schedule M and international quality systems
- Practical, implementation-focused approach
- Customized SOPs and documentation
- Training and post-implementation support
- Independent GMP and QMS audits