Home/ Certifications/ WHO GMP

Get WHO GMP Certification & Compliance Support in India

WHO Good Manufacturing Practices (WHO GMP) are internationally recognized principles used to ensure that medicinal products are consistently produced and controlled according to appropriate quality standards and their intended use.

WHO itself does not simply issue a generic commercial "WHO GMP certificate" to every manufacturer. GMP compliance is established through the applicable regulatory or certification framework, and the responsible authority issues the relevant documentation.

GMP Gap Assessment

Quality Documentation

Personnel Training

Validation & Qualification

Self-Inspection

Inspection Preparation

Apply for WHO GMP Support Talk to a GMP Consultant

Pharmaceutical GMP Focus End-to-End Support 100% Data Privacy

Need WHO GMP Compliance Support?

Share your manufacturing details. Our expert will review your facility's GMP readiness and applicable regulatory requirements.

Full Name

Mobile Number

Email Address

Business Type

Manufacturing Category

Existing GMP Status

Purpose of Compliance

Your information is secure and confidential.

Overview

WHO GMP Is a Framework for Consistent Pharmaceutical Quality

GMP is an important part of pharmaceutical quality assurance. It covers manufacturing and quality-control practices designed to reduce risks such as contamination, cross-contamination, mix-ups, incorrect labelling and other failures that may affect the quality, safety or efficacy of medicinal products.

Not a Generic Commercial Certificate

WHO does not directly issue a generic "WHO GMP certificate" to every manufacturer. GMP compliance is established through the applicable regulatory or certification framework.

Regulatory Inspection Route

GMP compliance is often assessed through inspection by a competent regulatory authority, which can enforce GMP compliance or support manufacturing authorization.

WHO Certification Scheme

WHO provides GMP guidance and operates a Certification Scheme on the quality of pharmaceutical products moving in international commerce, supporting regulatory authorities.

Pharmaceutical manufacturing facility with quality control processes

WHO GMPGood Manufacturing Practices

What We Help You With

A complete GMP compliance journey, end to end, from gap assessment to regulatory inspection preparation.

Initial Facility Assessment

Manufacturing, quality control, premises and equipment reviewed upfront.

GMP Gap Assessment

Existing practices compared against applicable WHO GMP requirements.

GMP Documentation Support

SOPs, batch records, specifications and quality records organized as required.

WHO GMP

Compliance
Support

Training & Validation Support

Personnel training and qualification/validation documentation guidance provided.

Internal GMP Review

Self-inspection support to evaluate readiness before regulatory inspection.

Regulatory Inspection Preparation

Coordination and preparation support ahead of the competent authority's inspection.

Compliance Support For

Who Needs GMP Certification or Compliance

GMP requirements are primarily relevant to manufacturers of medicinal and other regulated health products.

Pharmaceutical Manufacturers Formulation & API Manufacturers Biological & Vaccine Manufacturers Herbal-Medicine Manufacturers Sterile Product Manufacturers Contract Manufacturers Contract Testing Organizations Medicinal Gas Manufacturers Pharmaceutical Excipient Manufacturers Investigational Product Manufacturers

Clear Expectations

What GMP Compliance Does Not Guarantee

GMP compliance demonstrates a controlled and documented manufacturing system — it does not itself guarantee outcomes such as the following.

Zero product defects, ever

Automatic product marketing authorization

Approval to sell in every market

Guaranteed export approval

A one-time, permanent certificate

Fixed, artificial compliance timelines

The Compliance Process

How WHO GMP Compliance Preparation Works

From initial gap assessment to regulatory inspection and GMP status.

Initial Assessment & Gap Analysis

Manufacturing, QC, premises, equipment and documentation reviewed against GMP requirements.

Documentation, Training & Improvements

SOPs established, personnel trained, and identified gaps addressed in the facility.

Qualification, Validation & Internal Review

Applicable equipment and processes qualified or validated; internal GMP review performed.

Regulatory Inspection & GMP Status

Competent authority conducts inspection; GMP documentation issued according to the applicable framework.

Documents & Information

What You Should Keep Ready

Exact requirements depend on the product type, dosage form, facility and applicable regulatory jurisdiction. The following are commonly relevant.

Quality Manual / Site Master File

SOPs & Batch Manufacturing Records

Specifications & Test Methods

Validation & Qualification Records

Training & Calibration Records

Deviation, CAPA & Change-Control Records

Important: Documents such as Aadhaar, PAN, Voter ID, Passport, Driving Licence, Bank Statement or Electricity Bill are not themselves WHO GMP requirements. They may be requested separately for business or identity verification only.

Clear Distinction

WHO GMP vs ISO 9001 vs ISO 13485

Different standards for different purposes — do not use them interchangeably.

Feature	WHO GMP	ISO 9001	ISO 13485
Focus	Pharmaceutical manufacturing & quality requirements	General Quality Management System	Medical-device Quality Management System
Applicable to	Regulated medicinal-product manufacturers	Organizations across many industries	Medical-device manufacturers specifically
Assessed by	Competent regulatory authority / applicable scheme	Accredited ISO certification body	Accredited ISO certification body
Does one replace another?	No — separate from ISO 9001 / ISO 13485	No — does not substitute for pharmaceutical GMP	No — does not substitute for pharmaceutical GMP

GMP, ISO 9001 and ISO 13485 should not be presented as identical certifications. A manufacturer may need more than one depending on its products and regulatory framework.

What You Receive

After Successful GMP Compliance Support

The exact deliverables depend on the applicant's facility, product category and the applicable authority's assessment outcome.

GMP Gap Assessment Report GMP Documentation Set Training & Qualification Support Internal GMP Review Support Regulatory Inspection Preparation GMP Status per Applicable Framework

Compliance is only one part of the journey — ongoing quality systems, training, validation and internal reviews must continue afterward.

FAQs

Frequently Asked Questions

Clear answers before you start your WHO GMP compliance journey.

WHO GMP means Good Manufacturing Practices developed and published by the World Health Organization for pharmaceutical and other relevant health-product manufacturing contexts.

Not as a generic commercial certificate. WHO provides GMP guidance and operates a pharmaceutical Certification Scheme; GMP compliance is assessed within applicable regulatory frameworks, often through competent national authorities.

GMP is particularly relevant to manufacturers of medicinal products and other regulated health products, depending on the applicable regulatory framework.

GMP requirements can be legally mandatory for regulated pharmaceutical manufacturing. The exact obligations depend on the country, product and applicable regulatory authority.

No. GMP focuses specifically on pharmaceutical manufacturing and quality requirements, while ISO 9001 is a general QMS standard and ISO 13485 applies specifically to medical devices.

No. GMP reduces manufacturing and quality risks through controlled processes, documentation and oversight, but it cannot guarantee zero defects.

No. GMP compliance, marketing authorization and export approval are separate regulatory matters that depend on the destination country and applicable authority.

Potentially yes, provided the facility and manufacturing operations meet the applicable GMP and regulatory requirements.

The manufacturer must continuously maintain GMP compliance through quality systems, training, documentation, validation, monitoring, internal reviews and regulatory inspections as applicable.

No. They are not GMP requirements. They may be requested separately for administrative or business verification.

Ready to Start Your WHO GMP Compliance Journey?

Build a manufacturing and quality system that reflects your real GMP obligations — not just paperwork for an inspection.

Initial GMP Assessment → Gap Analysis → Documentation → SOP Development → Training → Facility & Process Review → Qualification/Validation Support → Internal GMP Review → Corrective Actions → Regulatory Inspection Preparation

Apply for WHO GMP Support