WHO GMP Certification Services in India by Biomaxgen

At Biomaxgen, we specialize in offering comprehensive consultancy services to the pharmaceutical industry, with a dedicated focus on assisting companies in obtaining WHO GMP certification across India. Our mission is to guide pharmaceutical manufacturers, exporters, and healthcare product developers through the complex regulatory landscape by offering strategic, customized, and end-to-end support. We work with all scales of businesses—whether you're an SME just starting out or a large-scale manufacturer seeking to expand into regulated markets.

Understanding WHO GMP Certification

WHO-GMP (World Health Organization - Good Manufacturing Practices) is a globally recognized quality standard that ensures the safety, quality, and efficacy of pharmaceutical products. It sets the minimum requirements that a pharmaceutical manufacturer must meet to ensure that their products are consistently high in quality, appropriate for their intended use, and meet the requirements of the marketing authorization or product specification.

This certification is crucial for Indian pharmaceutical companies looking to enter international markets, especially in countries where WHO compliance is a prerequisite for product registration and import.

Why WHO GMP Certification Matters

For pharmaceutical companies in India, achieving WHO GMP certification is not just a quality milestone but also a gateway to global business opportunities. Here’s why it is essential:

• Global Market Access: WHO GMP certification opens the doors to export markets, especially in African, Southeast Asian, Latin American, and CIS countries.

• Compliance with International Standards: It demonstrates adherence to the highest quality and safety norms.

• Enhanced Brand Credibility: Certified companies gain trust and recognition among healthcare professionals, partners, and regulatory bodies.

• Improved Manufacturing Practices: WHO GMP guidelines improve overall plant operations, quality control, and production consistency.

• Increased Investment Opportunities: Investors and collaborators prefer working with WHO-GMP-compliant companies due to their adherence to global benchmarks.

Our WHO GMP Consultancy Services

Biomaxgen offers a full suite of WHO GMP Certification consultancy services tailored to your company’s needs. Whether you’re setting up a new facility or upgrading your current operations, our experienced consultants ensure a seamless journey from start to certification. Our key offerings include:

1. Gap Analysis and Initial Assessment

We begin with a comprehensive assessment of your current manufacturing practices, infrastructure, documentation, and quality systems. This gap analysis helps us identify deviations from WHO GMP guidelines and allows us to design a corrective and preventive action plan (CAPA).

2. Documentation Support

WHO GMP certification heavily depends on documentation accuracy and completeness. We assist you in creating, updating, and organizing essential documents such as:

• Quality Manual

• SOPs (Standard Operating Procedures)

• Master Validation Plans

• Batch Manufacturing Records (BMR)

• Training Records

• Equipment Qualification and Calibration Reports

• Risk Assessments

3. Facility Layout and Process Design

Our consultants provide guidance on optimizing your plant layout, material flow, HVAC systems, water systems, and waste disposal processes to align with WHO GMP standards. We help design hygienic and efficient facility models that prevent cross-contamination and ensure product integrity.

4. Quality Management System (QMS) Implementation

We assist in the design and implementation of a robust Quality Management System that aligns with WHO GMP requirements. This includes setting up quality control (QC) and quality assurance (QA) protocols, change control procedures, deviation management, and internal audits.

5. Training and Staff Development

To maintain WHO GMP standards, your team must be well-trained in GMP principles. We provide on-site and virtual training sessions for production, QC, QA, engineering, and management personnel, helping them understand their responsibilities in maintaining GMP compliance.

6. Audit Readiness and Mock Inspections

Biomaxgen conducts internal audits and mock inspections to evaluate your site’s readiness for an official WHO GMP inspection. We simulate regulatory audits to help your team gain confidence and understand the inspection process. Our audit team provides detailed reports and action plans to close any gaps found.

7. Application Filing and Liaison Support

We guide you through the application process, including submission of dossiers, regulatory filings, and communication with relevant authorities. Our team coordinates with State FDAs, CDSCO, and international WHO representatives, ensuring timely responses and follow-ups.

8. Post-Certification Support

GMP compliance is a continuous journey. After certification, we continue to support your business through periodic audits, system upgrades, training refreshers, and help with maintaining compliance during scale-up, new product introduction, or technology transfer.

Who Can Benefit From Our Services?

Biomaxgen’s WHO GMP consultancy services are ideal for:

• Pharmaceutical Formulation Manufacturers

• Active Pharmaceutical Ingredient (API) Manufacturers

• Veterinary Drug Producers

• Nutraceutical and Herbal Medicine Manufacturers

• Contract Manufacturing Organizations (CMOs)

• Export-Oriented Units

• New pharma startups planning to build GMP-compliant facilities

Why Choose Biomaxgen?

✅ Industry Expertise

With years of hands-on experience in pharmaceutical regulatory consultancy, Biomaxgen brings unmatched technical know-how and strategic insight into every project.

✅ Personalized Consulting

We do not offer one-size-fits-all solutions. Every company is unique, and so are its challenges. Our consulting is customized to your company’s product line, scale, regulatory needs, and budget.

✅ End-to-End Services

From facility design to post-certification maintenance, we provide complete support throughout the certification lifecycle.

✅ Fast Turnaround Time

We value your time. Our efficient processes and strong liaison with regulatory bodies help reduce the certification timeline significantly.

✅ Affordable and Transparent Pricing

Our services are competitively priced with no hidden costs. We believe in building long-term relationships based on transparency and mutual growth.

The Biomaxgen Process – Step-by-Step

1. Initial Consultation & Feasibility Study

2. Gap Analysis & Site Visit

3. Customized Compliance Plan

4. Documentation and QMS Setup

5. Staff Training and Awareness Programs

6. Audit Simulation and Corrective Actions

7. Application Filing and Coordination with Authorities

8. Final Certification and Post-Audit Support

Let’s Build a Globally Compliant Future Together

WHO GMP certification is not just a requirement—it’s a commitment to quality, safety, and global responsibility. At Biomaxgen, we stand as your trusted partner in achieving and maintaining this benchmark. Whether you're starting from scratch or upgrading your facility, we are here to ensure a smooth, efficient, and successful certification journey.