GMP System Setup

GMP System Setup

Build the System Before the Batch

A strong GMP system is the backbone of every compliant pharmaceutical operation. Agon’s GMP System Setup service helps new and expanding facilities establish end-to-end quality systems aligned with international standards. From SOP creation to document control, we lay the foundation for sustainable compliance—customized to your product, scale, and jurisdiction.

What We Deliver

Quality Management System (QMS) Design

SOP library creation and hierarchy mapping
Quality Manual, Policy, and Master Index design
Integration of deviations, CAPA, change control, and complaints modules

Documentation Control & Records Management

Document lifecycle management: creation, review, approval, distribution, and archiving
Templates and workflows aligned with data integrity and traceability needs
Electronic or hybrid document control system setup

Cross-Functional Implementation

Department-wise training on QMS roles and responsibilities
Review mechanisms and quality metrics dashboards
Internal audit planning and QMS effectiveness evaluation

Why It Matters

Enables inspection readiness at all times
Avoids non-compliance due to undocumented or ad hoc practices
Supports seamless onboarding of new employees and third parties
Establishes traceability, accountability, and control
Essential for obtaining GMP licenses and global regulatory approvals

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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