Achieve WHO GMP Certification & Global Compliance

Navigate the path to obtaining WHO Good Manufacturing Practices (GMP) certification. We provide comprehensive support, ensuring your pharmaceutical or healthcare business meets international quality standards for global market access.

WHO GMP Certification
Quality Management Systems
Documentation & Audits
Global Market Access
Pharmaceutical Compliance

End-to-End WHO GMP Certification & Compliance

We streamline the entire WHO GMP certification process, from initial assessment to successful audit, ensuring your operations meet rigorous international standards.

Gap Analysis & Pre-Assessment

We conduct a thorough assessment of your current facilities and processes against WHO GMP guidelines.

Detailed review of manufacturing practices and quality systems
Identification of areas requiring improvement for compliance
Benchmarking against WHO's stringent quality standards
Strategic recommendations for achieving full compliance
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Documentation & QMS Development

We assist in developing and optimizing your Quality Management System (QMS) and all necessary documentation.

Creation of Standard Operating Procedures (SOPs)
Development of batch records, validation protocols, and reports
Ensuring data integrity and robust record-keeping practices
Staff training on WHO GMP principles and QMS implementation
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Facility Upgrades & Audit Readiness

We guide you through necessary facility modifications and prepare your team for the official WHO GMP audit.

Advice on cleanroom design, utilities, and equipment validation
Mock audits and internal inspection preparation
Support during the official WHO inspection process
Assistance with responding to audit observations and CAPAs
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Post-Certification & Continuous Improvement

Our support extends beyond certification, ensuring ongoing compliance and continuous improvement of your QMS.

Guidance on maintaining certification requirements
Assistance with periodic reviews and recertification audits
Updates on evolving WHO GMP guidelines and regulatory changes
Support for implementing continuous quality improvement initiatives
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Your Path to WHO GMP Certification

A clear and efficient process to achieve international recognition for your pharmaceutical quality.

1

Initial Assessment & Planning

We begin with a comprehensive gap analysis and develop a tailored certification plan.

2

QMS Development & Documentation

Assistance in establishing a robust QMS and preparing all required WHO GMP documents.

3

Implementation & Audit Preparation

Guiding facility upgrades, implementing QMS, and preparing your team for the audit.

4

Certification & Ongoing Compliance

Ensuring successful certification and providing continued support for maintaining standards.

Ready to Achieve WHO GMP Certification?

Unlock global market access and build trust by meeting the highest international quality standards. Let's start your WHO GMP journey!

Get Your WHO GMP Certification