How to Apply for a WHO-GMP Certificate Step-by-Step Guide

As you are aware, the pharmaceutical healthcare industry is one of the most heavily regulated sectors in the world. 

The pharmaceutical Companies that manufacture medicines, injectables, capsules, syrups or other healthcare products.

 The WHO-GMP Certificate is one of the most important certifications in this  industry. These companies follow internationally recognized manufacturing practices, ensuring product quality, safety, and efficacy.

A WHO-GMP certificate not only boosts credibility It also opens global export opportunities.Many countries accept WHO-GMP certification as a benchmark for importing pharmaceutical products. If you are a manufacturer thinking of expanding globally, applying for this certificate is a critical step.

Let’s explore and know all these steps, and how to apply for a WHO-GMP certificate.

Step 1: Understand the WHO-GMP Guidelines

Before applying, the first step is to understand what WHO-GMP is and what it requires.

The guidelines define a set of principles and processes to ensure that products are consistently produced and controlled according to quality standards.

Key areas include:

● Clean and controlled manufacturing environment

● Proper documentation and record keeping

● Qualified staff and training programs

● Validated production and quality control methods

● Proper packaging, labeling, and storage

● Complaint redressal and product return systems

Being familiar with these standards will help you prepare better and reduce the chances of rejection during inspection.

Step 2: Prepare Your Facility

When you understand the requirements, the next step is to prepare your manufacturing facility to meet WHO-GMP standards.

This includes:

● Ensuring that your plant layout adheres to a clean and safe design.

● Installing equipment that meets quality standards.

● Implementing standard operating procedures (SOPs).

● Establishing quality assurance and quality control departments.

● Training employees on GMP practices.

At this stage, many companies conduct internal audits or hire consultants specializing in WHO-GMP compliance. This helps identify deficiencies and make corrections before an official inspection.

Step 3: Collect the required documents

Applying for a WHO-GMP certificate requires extensive documentation. Officials will ask you for proof that your facility adheres to WHO-GMP principles.

Commonly required documents include:

● Application form (as prescribed by the licensing authority)

● List of products manufactured

● Site Master File (SMF) detailing the plant layout, processes, and facilities

● Equipment details and calibration

● Standard operating procedures for production, packaging, testing, and checking quality

● Employee qualification and training records

● Quality assurance and control system details

● Stability study and report

Accurate all documentation’s role in obtaining approval.

Step 4: Apply to the licensing authority​

In India, the State of Drug Licensing Authority (SDLA) or the Central Drugs Standard Control Organization (CDSCO) is responsible for WHO-GMP certification.

Manufacturers must submit a completed application form along with the required documents and the prescribed fee.

Depending on the type of product (human medicines, veterinary products, or medical devices), officials may require additional details.​

After submitting the documents, officials will review them and schedule a site inspection.

Step 5: Site Inspection and Audit

The most important step in the certification process is an inspection of your plant by qualified auditors. During this inspection, officials will verify that your manufacturing plant complies with WHO-GMP standards.

They will:

● Inspect manufacturing areas, storage facilities, and laboratories.

● Verify sanitation and hygiene practices.

● Review documents, standard operating procedures (SOPs), and records.

● Inspect quality control systems and testing laboratories.

● Evaluate employee knowledge and training.

If auditors identify any compliance deficiencies, they can provide suggestions and timelines for corrective action. Once the corrections are made, a re-inspection can be conducted.

Step 6: Approval and Certificate Issuance

If your facility meets all requirements, the licensing authority will issue a WHO-GMP certificate. This certificate confirms that your company follows WHO-recommended manufacturing practices. This certificate is typically valid for 2-3 years, after which it must be renewed.

The certificate will also list the products that are WHO-GMP compliant. Companies often display this certification to enhance brand credibility and apply for international tenders or export approvals.

Step 7: Maintain ongoing compliance

Obtaining certification isn't everything; maintaining it is equally important. WHO-GMP is based on the principle of continuous improvement.

Companies must:

● Conduct regular internal audits.

● Train employees periodically.

● Keep documents up-to-date.

● Upgrade equipment and technology to the latest standards.

● Report any changes to the facility or production to the authorities.

Failure to maintain compliance may result in the certificate being suspended or revoked.

Benefits of WHO-GMP Certification

Applying for and obtaining WHO-GMP certification offers several benefits:

● Global recognition – Accepted by many countries as proof of quality.

● Export – Facilitates entry into regulated markets.

● Trust – Builds confidence among healthcare professionals.

● Quality systems – Improves internal processes and efficiency.

● Competitive edge – Helps secure contracts.

Conclusion

Applying for WHO-GMP certification is a systematic process that requires planning, preparation, and strict adherence to guidelines.

From understanding the standards and preparing your facility to documentation, inspection, and certification, every step requires meticulous attention.

For pharmaceutical companies looking to expand globally, WHO-GMP certification is more than just recognition—it's a gateway to international trust and market opportunities.

By following the step-by-step process outlined above, manufacturers can confidently apply for WHO-GMP certification and ensure that their products meet the highest global quality standards.