Documentation Assistance & Quality Management

At Magnificent Concept, we offer specialized qualification and validation services to ensure your facilities, equipment, and processes meet the highest regulatory and quality standards. Our approach combines technical expertise, strategic documentation, and a deep understanding of international regulatory expectations.

Whether you're setting up a new facility or upgrading an existing one, our team guides you through each critical step ensuring compliance, consistency, and readiness for regulatory audits.

Facility & Equipment Qualification

We help pharmaceutical companies implement robust qualification protocols for both facilities and equipment. Our services include:

• Development and execution of qualification protocols (DQ, IQ, OQ, PQ)

• Equipment verification and documentation

• Facility qualification aligned with GMP requirements

• Support for HVAC, water system, cleanroom, and utility validations

SOP Development & QMS Implementation

• Drafting and customizing SOPs across departments including Production, QA/QC, Engineering, Warehouse, and more

• Reviewing existing SOPs for gaps and compliance risks

• Implementation and integration of a full Quality Management System (QMS) with controlled documentation processes

• Ensuring alignment with GxP and global regulatory guidelines

GMP Gap Assessment & Upgradation

Stay audit-ready and regulation-compliant with our structured GMP review and enhancement services:

• Comprehensive GMP gap assessments

• Site inspection and documentation audits

• Upgrade planning in line with USFDA, EMA, WHO, and PIC/S guidelines

• Remediation support and compliance action planning

GxP Training & Workforce Readiness

We believe that a trained workforce is the backbone of compliance and operational excellence. Our expert trainers deliver practical, impactful sessions on:

• Good Manufacturing Practices (GMP)

• Good Documentation Practices (GDP)

• Good Laboratory Practices (GLP)

• Data Integrity & Electronic Record Compliance

• QMS Principles and Risk Management

• Customized training modules for site-specific needs